Table of Contents

Section 1
Section 2
Section 3
FDA EFOIA Reading Room

FOI Documents 140-000 - 149-999

Listed with Abstracts from the Summaries

NADA 140-011 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin hydrogen fumarate + chlortetracycline (equivalent to chlortetracycline hydrochloride)
Trade Name: Denagard® 10; chlortetracycline premixes
Indications for Use: For the control of swine dysentery associated with Serpulina hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by Pasteurella multocida sensitive to chlortetracycline.
Date of Approval: August 20, 1996

NADA 140-014 original approval
Sponsor: Ausa International Inc.
Generic Name: Follicle stimulating hormone (FSH)
Trade Name: SUPER-OV®
Indications for Use: SUPER-OV® is indicated for the induction of superovulation in cows for procedures requiring the production of multiple ova at a single estrus. SUPER-OV® is effective only in cows that are not pregnant and have a normal corpus luteum, i.e. those cows that are cycling normally.
Date of Approval: August 13, 1993

NADA 140-269 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: ketoprofen
Trade Name: Ketofen™
Indications for Use: Ketofen(TM) is indicated for the alleviation of inflammation and pain associated with musculoskeletal disorders in the horse.
Date of Approval: September 26, 1990

NADA 140-270 original approval
Sponsor: Medico Industries, Inc.
Generic Name: sulfamethazine
Trade Name: Sulfamethazine Sustained Release Bolus
Indications for Use: Sulfamethazine Sustained Release Bolus is indicated for the treatment of the following diseases in beef cattle and non-lactating dairy cattle: Bovine respiratory disease complex (shipping fever complex) associated with Pasteurella spp.; bacterial pneumonia associated with Pasteurella spp.; necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum; colibacillosis (bacterial scours) caused by Escherichia coli; coccidiosis caused by Eimeria bovis and E. zurnii; acute mastitis and metritis caused by Streptococcus spp.
Date of Approval: August 25, 1986

NADA 140-288 supplemental approval
Sponsor: The Upjohn Company
Generic Name: melengestrol acetate, lasalocid, tylosin
Trade Name: MGA®100/200 Premix, MGA®500 Liquid Premix, BOVATEC®, TYLAN®
Effect of Supplement: This supplement provides for removal of the requirement of a pre-slaughter drug withdrawal period for heifers fed melengestrol acetate when melengestrol acetate is fed in combination either with lasalocid or with lasalocid and tylosin.
Date of Approval: June 29, 1994

NADA 140-338 original approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: Naxcel Sterile Powder
Indications for Use: Naxcel Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia).
Date of Approval: January 25, 1988

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: Naxcel Sterile Powder
Effect of Supplement: This supplemental application provides for a change in the approved dosage of 0.5 mg/lb body weight to a range of 0.5 mg to 1.0 mg ceftiofur sodium/lb of body weight.
Date of Approval: April 5, 1990

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium
Trade Name: NAXCELR® Sterile Powder
Effect of Supplement: Provides for the use of ceftiofur sodium (NAXCEL Sterile Powder) in lactating dairy cattle, a new class of animal, for the same indications approved in the parent NADA.
Date of Approval: March 15, 1991

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: This supplement provides for an additional species, swine, to be added to the previously approved product, NAXCEL®
Date of Approval: August 4, 1992

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: The supplement provides data in support of a request for approval of Naxcel ® Sterile Powder for an additional species (equine). The issue of the Freedom of Information (FOI) Summary should be considered an extension of previously approved version describing data in support of Naxcelreg., NADA 140-338, approved as a treatment for respiratory disease in cattle January 25, 1988.
Date of Approval: July 13, 1994

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: Provides for the use of ceftiofur sodium (NAXCEL® Sterile Powder) in cattle for a new indication.
Date of Approval: August 24, 1995

NADA 140-338 supplemental approval
Sponsor: The Upjohn Company
Generic Name: Ceftiofur sodium
Trade Name: NAXCEL® Sterile Powder
Effect of Supplement: Provides for an additional species, day-old turkey poults, to be added to the previously approved product, NAXCEL® Sterile Powder; also provides for revision of the chick indication.
Date of Approval: May 21, 1996

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: Naxcel® Sterile Powder
Effect of Supplement: The approval of this supplement will allow for the use of ceftiofur sodium (NAXCEL Sterile Powder) for the treatment of bacterial pneumonia in sheep.
Date of Approval: October 25, 1996

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: Naxcel® Sterile Powder
Effect of Supplement: The approval of this supplement will allow for the use of ceftiofur sodium (NAXCEL? Sterile Powder) for the treatment of bacterial pneumonia in goats to be added to the previously approved NAXCEL label.
Date of Approval: March 7, 2001

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium sterile powder
Trade Name: NAXCEL® brand of ceftiofur sodium sterile powder.
Effect of Supplement: Provides for the use of a subcutaneous (SC) route of administration for NAXCEL® Sterile Powder in cattle.
Date of Approval: May 29, 2001

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: This supplement provides four specific changes to the product insert, 1) revision of the “clinical microbiology” section to update the MIC table using the new MIC data for ceftiofur, 2) the addition of a table listing acceptable quality control ranges for ceftiofur, 3) the addition of the latest National Committee for Clinical Laboratory Standards (NCCLS) reference at the end of the insert, and 4) clarification of the statement under “Storage Conditions” dealing with the storage of reconstituted Naxcel via freezing.
Date of Approval: December 31, 2003

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn
Generic Name: ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: This supplement updates survey microbiological data and adds the National Committee for Clinical Laboratory Standards’ (NCCLS) interpretive criteria for equine isolates to the NAXCEL Sterile Powder package insert.
Date of Approval: February 27, 2004

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: For the treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis type 2.
Date of Approval: June 18, 2004

NADA 140-338 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur sodium
Trade Name: NAXCEL Sterile Powder
Effect of Supplement: To establish a 4-day pre-slaughter withdrawal period for cattle
Date of Approval: June 2, 2006

NADA 140-339 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: Nicarbazin, bambermycins
Trade Name: Nicarb®, Flavomycin®
Indications for Use: As an aid in preventing outbreaks of cecal coccidiosis caused by Eimeria tenella, intestinal coccidiosis caused by E. acervulina, E. maxima, E. nectarix, and E. brunetti,, increased rate of weight gain and improved feed efficiency.
Date of Approval: August 6, 1999

NADA 140-340 original approval
Sponsor: Roussel-Uclaf
Generic Name: lincomycin, halofuginone hydrobromide
Trade Name: Lincomix®, Stenorol®
Indications for Use: For the prevention of coccidiosis caused by E. tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for improved feed efficiency in broiler chickens.
Date of Approval: March 21, 1989

NADA 140-439 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: EQVALAN Liquid
Indications for Use: For treatment and control of the following parasites or parasitic conditions in horses: bots, large mouth stomach worms, neck threadworms, pinworms, ascarids, lungworms, intestinal threadworms, small strongyles large strongyles, summer sores, and dermatitis caused by neck threadworm microfilariae.
Date of Approval: July 1, 1987

NADA 140-439 supplemental approval
Sponsor: Merial Ltd.
Generic Name: ivermectin
Trade Name: EQVALAN Liquid For Horses
Effect of Supplement: This supplement amends the EQVALAN (ivermectin) Oral Liquid For Horses labeling to add four species of internal parasites and to reflect a change in the Indications section which separates the listing of adult small strongyle species from their related fourth-stage larvae. Specifically, the supplement provides for the use of ivermectin oral liquid for the treatment and control of Craterostomum acuticaudatum, Petrovinema poculatum, and Coronocyclus spp. including Coronocyclus coronatus and Coronocyclus labratus. In addition, under the sub-heading Small Strongyles, the labeling has been revised to separate the listing of adult species from their related fourth-stage larvae.
Date of Approval: August 9, 2004

NADA 140-441 original approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Indications for Use: For the treatment of dermal infections, respiratory infections, and urinary cystitis caused by susceptible strains of bacteria in dogs.
Date of Approval: December 27, 1988

NADA 140-441 supplemental approval
Sponsor: Mobay Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® Antibacterial Tablets
Effect of Supplement: This supplemental application amends the NADA to remove the contradiction against use in breeding female dogs.
Date of Approval: June 6, 1990

NADA 140-441 supplemental approval
Sponsor: Bayer Corporation
Generic Name: enrofloxacin tablets and enrofloxacin injectable solution
Trade Name: Baytril® Antibacterial Tablets and Baytril® Antibacterial Injectable Solution
Effect of Supplement: Revises dosage frequency, indications, and limitations.
Date of Approval: June 18, 1997

NADA 140-441 supplemental approval
Sponsor: Bayer Corp., Agriculture Division, Animal Health Division
Generic Name: enrofloxacin
Trade Name: Baytril® Taste Tabs™ Antibacterial Tablets
Effect of Supplement: For the management of diseases in dogs and cats associated with bacteria susceptible to enrofloxacin.
Date of Approval: August 3, 1999

NADA 140-442 original approval
Sponsor: Med-Tech, Inc.
Generic Name: xylaxine HCl
Trade Name: Xylazine HCl Injection
Indications for Use: Xylazine HCl Injection should be used in horses when it is desirable to produce a state of sedation. It has been successfully used when conducting various diagnostic, orthopedic and dental procedures and for minor surgical procedures of short duration. It may also be used as a preanesthetic to local or general anesthesia.
Date of Approval: February 18, 1988

NADA 140-443 original approval
Sponsor: Arkansas Micro Specialties, Inc.
Generic Name: hygromycin B
Trade Name: Hygromix 0.6 and 1.6 Premixes
Indications for Use: SWINE: Control of infestations of large roundworms (Ascaris suis), nodular worms (Oesophagostomum dentatum) and whipworms (Trichuris suis). CHICKENS: Control of infestations of large roundworms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). Discontinue swine feeds containing hygromycin B 15 days before slaughter. Discontinue chicken feeds containing hygromycin B 3 days before slaughter.
Date of Approval: May 30, 1986

NADA 140-445 original approval
Sponsor: Elanco Products Company
Generic Name: narasin + roxarsone (3-nitro-4-hydroxyphenylarsonic acid)
Trade Name: Monteban® + Roxarsone
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by bacteria that are more susceptible to roxarsone combined with narasin than to narasin alone.
Date of Approval: June 28, 1988

NADA 140-448 original approval
Sponsor: Roussel-Uclaf
Generic Name: oxytetracycline + salinomycin sodium
Trade Name: Terramycin + Bio-Cox
Indications for Use: As an aid in the reduction of mortality due to air sacculitis (air sac infection) caused by Escherichia coli sensitive to oxytetracycline and for the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati and E. maxima .
Date of Approval: April 13, 1990

NADA 140-474 original approval
Sponsor: Sterivet Laboratories Limited
Generic Name: hyaluronate sodium
Trade Name: Synacid™
Indications for Use: For the treatment of equine carpal and fetlock joint dysfunction caused by traumatic and/or degenerative joint disease of mile to moderate severity.
Date of Approval: June 1, 1988

NADA 140-530 original approval
Sponsor: Agri-Basics
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonia caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: June 3, 1986

NADA 140-531 original approval
Sponsor: Agri-Basics
Generic Name: tylosin (as tylosin phosphate)
Trade Name: Tylan 5, 10, 20 & 40 Premix
Indications for Use: SWINE: For increased rate of weight gain and improved feed efficiency. BEEF CATTLE: For reduction of incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes . CHICKENS: For increased rate of weight gain and improved feed efficiency. LAYING CHICKENS: Improving feed efficiency. BROILER AND REPLACEMENT CHICKENS: To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum .
Date of Approval: July 26, 1986

NADA 140-533 original approval
Sponsor: Roussel-Uclaf
Generic Name: bacitracin methylene disalicylate, roxarsone, halofuginone hydrobromide
Trade Name: Bacitracin MD, 3-Nitro, Stenorol
Indications for Use: For the prevention of coccidiosis caused by E. tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix and E. mivati ; For increased rate of weight gain and for improved feed efficiency in broiler chickens.
Date of Approval: January 11, 1988

NADA 140-578 original approval
Sponsor: Vetri-Tech, Inc.
Generic Name: tetracycline hydrochloride
Trade Name: Solu-Tet 324
Indications for Use: Chickens: Control of chronic respiratory disease (CRD) and air sac infection caused by Mycolplasma gallisepticum and Esherichia coli; infectious synovitis caused by Mycoplasma synoviae susceptible to otetracycline.
Date of Approval: February 26, 1991

NADA 140-579 original approval
Sponsor: Hoffmann-LaRoche, Inc.
Generic Name: lasalocid sodium, oxytetracycline (monoalkyl trimethyl ammonium salt)
Trade Name: Bovatec®, Terramycin
Indications for Use: For improved feed efficiency, increased rate of weight gain and reduction of the incidence and severity of liver abscesses in beef cattle fed in confinement for slaughter.
Date of Approval: December 18, 1987

NADA 140-581 original approval
Sponsor: A. H. Robbins Company, Inc.
Generic Name: salinomycin, roxarsone, and lincomycin
Trade Name: Bio-Cox®, 3-Nitro®, and Lincomix® (combined use)
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than to salincomycin alone; and for improved feed efficiency.
Date of Approval: May 31, 1989

NADA 140-582 original approval
Sponsor: Anthony Products Co.
Generic Name: oxytetracycline HCl
Trade Name: Oxytetracycline Hydrochloride Injection, 50 mg and 100 mg
Indications for Use: Oxytetracycline HCl (50 mg and 100 mg) is intended for use in the treatment of the following diseases in beef cattle and non-lactating dairy cattle when due to oxytetracycline-susceptible organisms: pneumonia and shipping fever complex associated with Pasteurella spp. and Hemophilus spp.; foot-rot and diphtheria caused by Fusobacterium necrophorum;bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline. If the product contains the statement "Federal law restricts this drug to use by or on the order of a licensed veterinarian," it may contain additional directions for use in beef cattle and non-lactating dairy cattle for the treatment of anaplasmosis caused by Anaplasma marginale and anthrax caused by Bacillus anthracis.
Date of Approval: March 15, 1988

NADA 140-583 original approval
Sponsor: Anthony Products Company
Generic Name: repository corticotropin injection
Trade Name: ACTH Gel
Indications for Use: ACTH (adrenocorticotropic hormone) stimulates the production of cortical hormones by the adrenal cortex. Corticotropin Injection is indicated primarily for use as a diagnostic aid to test for adrenal dysfunction in dogs. The product is also indicated for stimulation of the adrenal cortex, where there is a general deficiency of ACTH in dogs and cats.
Date of Approval: November 14, 1988

NADA 140-584 original approval
Sponsor: Roussel-Uclaf; Hoechst-Roussel Agri-Vet Company
Generic Name: bacitracin methylene disalicylate; halofuginone hydrobromide
Trade Name: Bacitracin MD; Stenorol
Indications for Use: For the prevention of coccidiosis by Eimeria acervulina, E. brunetti, E. maxima, E. mivati, E. necatrix, and E. tenella and improved feed efficiency in broiler chickens.
Date of Approval: March 16, 1988

NADA 140-680 original approval
Sponsor: Penfield Chemical Corporation
Generic Name: tylosin (as tylosin phosphate)
Trade Name: Tylan 5, 10, 20 & 40 Premix
Indications for Use: SWINE: For increased rate of weight gain and improved feed efficiency. For prevention of swine dysentery (vibrionic). For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis. For the treatment and control of swine dysentery (vibrionic) following initial medication of Tylan Plus Vitamins in drinking water. BEEF CATTLE: For reduction in the incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes . CHICKENS: For increased rate of weight gain and improved feed efficiency. LAYING CHICKENS: Improving feed efficiency. BROILER AND REPLACEMENT CHICKENS: To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum .
Date of Approval: July 24, 1987

NADA 140-681 original approval
Sponsor: Pennfield Chemical Corporation
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20, & 40 Sulfa-G Premixes
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonia caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: July 30, 1987

NADA 140-684 original approval
Sponsor: Fort Dodge Laboratories, Inc.
Generic Name: cefadroxil
Trade Name: CEFA-DROPS (cefadroxil) Veterinary Powder for Oral Suspension
Indications for Use: CEFA-DROPS (cefadroxil) is indicated for the treatment of the following conditions: DOGS: Genitourinary tract infections (cystitis) caused by susceptible strains of Escherichia coli, Proteus mirabilis, and Staphylococcus aureus . Skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections and abscesses caused by susceptible strains of Staphylococcus aureus . CATS: Skin and soft tissue infections including abscesses, wound infections, cellulitis and dermatitis caused by susceptible strains of Pasteurella multocida, Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus spp.
Date of Approval: July 20, 1988

NADA 140-806 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: hyaluronate sodium
Trade Name: Hyalovet®
Indications for Use: For the intra-articular treatment of carpal or fetlock joint dysfunction in horses due to acute or chronic, non-infectious synovitis associated with equine osteoarthritis.
Date of Approval: May 31, 1988

NADA 140-810 original approval
Sponsor: Biomed Laboratories
Generic Name: nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment
Trade Name: Panavet Ointment
Indications for Use: Panavet Ointment (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment) is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs, and in anal gland infections in dogs. The preparation is also indicated in the management of dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those cause, complicated, or threatened by bacterial or candidal (Candida albicans) infections. It is also of value in eczematous dermatitis, contact dermatitis, and seborrheic dermatitis, and as an adjunct in the treatment of dermatitis due to parasitic infestation.
Date of Approval: February 3, 1989

NADA 140-818 original approval
Sponsor: Merck Research Laboratories
Generic Name: efrotomycin
Trade Name: Producil
Indications for Use: For increased rate of weight gain when incorporated into complete swine feeds at 3.6 to 14.5 g/tons; for improved feed efficiency when incorporated into complete swine feeds at 3.6 g/ton.
Date of Approval: July 24, 1992

NADA 140-819 original approval
Sponsor: Pfizer Inc.
Generic Name: pyrantel tartrate
Trade Name: Strongid 48
Indications for Use: For the prevention of Strongylus vulgaris larval infections in horses. For control of the following parasites in horses: LARGE STRONGYLES (adults) S. vulgaris, S. edentatus, Triodontophorus spp. SMALL STRONGYLES (adult and fourth-stage larvae) Cyathostomum spp. Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., Poteriostomum spp., PINWORMS (adult and fourth-stage larvae) Oxyuris equi ASCARIDS (adult and fourth-stage larvae) Parascaris equorum.
Date of Approval: April 18, 1990

NADA 140-819 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: pyrantel tartrate
Trade Name: Strongid® 48
Effect of Supplement: This supplement provides for revised feeding instructions. It also provides for movement of the parasite Triodontophorus spp. from the Large Strongyles to the Small Strongyles in the indications section.
Date of Approval: August 24, 1999

NADA 140-820 original approval
Sponsor: Furst-McNess Company
Generic Name: tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name: Tylan 5, 10, 20 & 40 Sulfa-G Premixes
Indications for Use: For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebecterium pyogenes ). Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.
Date of Approval: January 9, 1987

NADA 140-824 supplemental approval
Sponsor: Roussel Uclaf
Generic Name: halofuginone hydrobromide
Trade Name: Stenorol®
Effect of Supplement: Change of tolerance.
Date of Approval: April 14, 1992

NADA 140-825 original approval
Sponsor: Furst-McNess Company
Generic Name: pyrantel tartrate
Trade Name: Swine Wormer-B
Indications for Use: CONTINUOUS FEEDING PROGRAM: For aid in the prevention of migration and establishment of large round worm (Ascaris suum )infections; for aid in the prevention of establishment of nodular worm (Oesophagostomum ) infections of swine. Feed continuously as the sole ration. THREE DAY THERAPEUTIC PROGRAM: For the removal and control of large roundworm (Ascaris suum ) infections of swine. Feed for three days as the sole ration. SINGLE THERAPEUTIC PROGRAM: For the removal and control of large roundworm (Ascaris suum ) and nodular worm (Oesphagostomum ) infections of swine. Withdraw this feed 24 hours prior to slaughter.
Date of Approval: September 24, 1986

NADA 140-828 original approval
Sponsor: BAYER Corporation
Generic Name: enrofloxacin
Trade Name: Baytril® (enrofloxacin) 3.23% Concentrate Antimicrobial Solution
Indications for Use: Chickens - Baytril® (enrofloxacin) 3.23% Concentrate Antimicrobial Solution is indicated for the control of mortality associated with E. coli susceptible to enrofloxacin.
Turkeys - Baytril® (enrofloxacin) 3.23% Concentrate Antimicrobial Solution is indicated for the control of mortality associated with E. coli and P. multocida (fowl cholera) susceptible to enrofloxacin.
Date of Approval: October 4, 1996

NADA 140-831 original approval
Sponsor: Argent Chemical Laboratories, Inc.
Generic Name: formalin
Trade Name: Paracide-F
Indications for Use: a. Formalin is indicated for the control of external parasites on cultured sport and food fishes: salmon, trout, catfish, largemouth bass, and bluegill. b. For control of fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs.
Date of Approval: February 3, 1989

NADA 140-833 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec-F® Injection For Cattle
Indications for Use: Ivomec-F Injection For Cattle is indicated for the treatment and control of the following species of gastrointestinal nematodes, lungworms, liver flukes, grubs, sucking lice, and mange mites of cattle.
Date of Approval: November 15, 1989

NADA 140-833 supplemental approval
Sponsor: Merck & Co., Inc.
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle.
Effect of Supplement: New claims for persistent control of gastrointestinal roundworms and lungworms.
Date of Approval: February 24, 1997

NADA 140-833 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Indications for Use: This supplemental application extends the period of persistent effect against infections of Dictyocaulus viviparus from 21 days to 28 days.
Date of Approval: March 21,1989

NADA 140-833 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin and clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Effect of Supplement: "...has been proved to effectively control infections and to protect from re-infection with Dictyocaulus viviparus for 28 days after treatment."
Date of Approval: April 1,1999

NADA 140-833 supplemental approval
Sponsor: Merial Limited
Generic Name: Ivermectin, clorsulon
Trade Name: Ivomec® Plus Injection for Cattle
Effect of Supplement: To extend the persistent effect periods for Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information and to add the veal calf warning statement to the residue information section.
Date of Approval: April 21, 2004

NADA 140-839 original approval
Sponsor: Beecham Laboratories
Generic Name: mupirocin
Trade Name: BACTODERM®
Indications for Use: BACTODERM® Ointment is indicated for the topical treatment of canine bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of the following organisms: Staphylococcus aureus and Staphylococcus intermedius.
Date of Approval: September 28, 1988

NADA 140-841 original approval
Sponsor: Merck Sharp and Dohme Research Laboratories
Generic Name: Ivermectin
Trade Name: IVOMEC Pour-On for Cattle
Indications for Use: For the treatment and control of gastrointestinal nematodes, lungworms, cattle grubs, sucking and biting lice, and sarcoptic mange mites.
Date of Approval: August 30, 1990

NADA 140-841 supplemental approval
Sponsor: Merck & Co.
Generic Name: ivermectin
Trade Name: Ivomec Pour-On® for Cattle
Effect of Supplement: New claims for persistent control of gastrointestinal roundworms
Date of Approval: June 5, 1997

NADA 140-841 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: Ivomec (ivermectin) Pour-On for Cattle
Effect of Supplement: To add the new persistent activity indications for Dictyocaulus viviparus for 28 days after treatment, Cooperia surnabada for 14 days after treatment, and Damalinia bovis for 56 days after treatment. To extend the persistent activity periods for Oesophagostomum radiatum from 14 to 28 days after treatment and Cooperia punctata and Trichostrongylus axei from 14 days to 21 days after treatment. At this time, the labeling is being revised to reflect updated environmental information, to speciate Cooperia spp in the treatment and control section of the indications, and to add the veal calf warning statement to the residue information section.
Date of Approval: November 24, 2003

NADA 140-842 original approval
Sponsor: MacPage, Inc.
Generic Name: hygromycin B
Trade Name: Hygromix 2.4 Premix
Indications for Use: SWINE: Control of infestations of large roundworms, nodular worms and whipworms . CHICKENS: Control of infestations of large roundworms, cecal worms, and capillary worms.
Date of Approval: August 5, 1987

NADA 140-843 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: narasin, bambermycins, roxarsone
Trade Name: Monteban®, Flavomycin®, 3-Nitro®
Indications for Use: To prevent coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens.
Date of Approval: December 23, 1997

NADA 140-844 original approval
Sponsor: American Cyanamid Co.
Generic Name: levamisole
Trade Name: TRAMISOL®
Indications for Use: TRAMISOL levamisole Pour-On is a broad spectrum anthelmintic which is effective against the following nematode infections in cattle when used in accordance with label directions: stomach worms, intestinal worms, and lungworms.
Date of Approval: January 21, 1988

NADA 140-845 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: bambermycins, narasin
Trade Name: Flavomycin, Monteban
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by susceptible organisms and for increased rate of weight gain and for improved feed efficiency in broiler chickens.
Date of Approval: February 7, 1989

NADA 140-846 original approval
Sponsor: Wildlife Laboratories, Inc.
Generic Name: melatonin implant
Trade Name: PRIME-X
Indications for Use: PRIME-X is recommended for use in healthy male and female kit and adult female mink selected for accelerated priming: PRIME-X implanted mink complete autumn molt and prime 4-6 weeks earlier than normal.
Date of Approval: June 21, 1994

NADA 140-847 original approval
Sponsor: Altana Inc.
Generic Name: nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment
Trade Name: Animax Ointment
Indications for Use: Animax Ointment (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment) is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs, and in anal gland infections in dogs. The preparation is also indicated in the management of dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal infections. It is also of value in eczematous dermatitis, contact dermatitis, and seborrheic dermatitis, and as an adjunct in the treatment of dermatitis due to parasitic infestation.
Date of Approval: September 30, 1988

NADA 140-848 original approval
Sponsor: Hoffman-La Roche Inc.
Generic Name: diazepam
Trade Name: Veteeze® Injection
Indications for Use: As a preanesthetic agent to reduce the amount barbiturate required for short duration anesthesia in dogs.
Date of Approval: December 17, 1992

NADA 140-850 original approval
Sponsor: Elite Chemical Corp., Inc.
Generic Name: dichlorophene-toluene worm capsules
Trade Name: Elite Dog & Cat Wormer, Elite Dog Wormer, Elite Cat Wormer
Indications for Use: For removal of ascarids and hookworms and as an aid in removal of tapeworms from dogs and cats.
Date of Approval: February 14, 1989

NADA 140-851 original approval
Sponsor: Hess & Clark, Inc.
Generic Name: 0.2% nitrofurazone dressing (water soluble) veterinary
Trade Name: NFZ Wound Dressing
Indications for Use: For the prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers of dogs, cats and horses (not for food use).
Date of Approval: July 7, 1989

NADA 140-852 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: narasin, roxarsone, bacitracin methylene disalicylate
Trade Name: Monteban®, 3-Nitro®, BMD®
Indications for Use: For the prevention of coccidiosis caused by susceptible organisms and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: July 5, 1989

NADA 140-852 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin Bacitracin methylene disalicylate Roxarsone
Trade Name: Monteban®, 3-Nitro®, BMD®
Date of Approval: July 29, 1998

NADA 140-853 original approval
Sponsor: A. L. Laboratories, Inc.
Generic Name: bacitracin methylene disalicylate, narasin
Trade Name: BMD®, Monteban®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati , and E. brunetti , for increased rate of weight gain, and for improved feed efficiency in broiler chickens.
Date of Approval: May 22, 1992

NADA 140-854 original approval
Sponsor: Syntex Animal Health, Inc.
Generic Name: oxfendazole
Trade Name: Synanthic®
Indications for Use: Oxfendazole is indicated for the treatment and control of: lungworms, stomach worms, and intestinal worms.
Date of Approval: September 17, 1990

NADA 140-854 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Oxfendazole
Trade Name: SYNANTHIC (oxfendazole) Bovine Dewormer Suspension, 22.5%
Effect of Supplement: This supplement provides for a change in marketing status from prescription (Rx) to over-the-counter (OTC) by removing the intraruminal route of administration on the 22.5% suspension.
Date of Approval: January 29, 2007

NADA 140-856 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: serum gonadotropin and chorionic gonadotropin for injection
Trade Name: P.G. 600 ®
Effect of Supplement: The original application provides for use of P.G.600 ® in prepuberal gilts. The supplement extends the conditions of use to include sows at weaning.
Date of Approval: August 30, 1993

NADA 140-857 original approval
Sponsor: Norden Laboratories, Inc.
Generic Name: luprostiol
Trade Name: Equestrolin™
Indications for Use: Indicated for 1) estrus control and 2) termination of pregnancy in mares.
Date of Approval: January 5, 1990

NADA 140-859 original approval
Sponsor: American Cyanamid Company
Generic Name: salinomycin sodium + chlortetracycline
Trade Name: BIO-COX® + AUREOMYCIN®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by susceptible organisms and as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: June 13, 1989

NADA 140-863 original approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride
Trade Name: Paylean®
Indications for Use: For increased rate of weight gain, improved feed efficiency, and increased carcass leaness in finishing swine fed a complete ration containing at least 16% crude protein from 150lbs (68kg) to 240lb (109 kg) body weight.
Date of Approval: December 22, 1999

NADA 140-863 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride
Trade Name: Paylean®
Indications for Use: To amend cautionary language in product labeling
Date of Approval: June 6, 2002

NADA 140-863 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride
Trade Name: PAYLEAN 9 and PAYLEAN 45
Effect of Supplement: This supplement provides for the replacement of the current indication and dosage with a new indication that allows use in pigs weighing in excess of 240 lb and a new dose range of 4.5 to 9.0 grams per ton. Additionally, this supplement updates the caution statement to reflect new animal safety data.
Date of Approval: April 25, 2006

NADA 140-865 original approval
Sponsor: Roche Vitamins Inc.
Generic Name: Narasin, Bacitracin zinc
Trade Name: MONTEBAN®, BACIFERM
Indications for Use: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima. For increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: August 7, 2000

NADA 140-865 supplemental approval
Sponsor: Alpharma Inc
Generic Name: Narasin, Bacitracin zinc
Trade Name: MONTEBAN®, ALBAC
Effect of Supplement: To provide for the addition of ALBAC® (bacitracin zinc) Type A Medicated article as an alternate source of bacitracin zinc for the approved combination of MONTEBAN® (narasin) and BACIFERM® (bacitracin zinc). No Federal Register required because there is no change to the CFR.
Date of Approval: April 29, 2002

NADA 140-866 original approval
Sponsor: VET-A-MIX, Inc.
Generic Name: yohimbine hydrochloride injectable solution
Trade Name: Yobine™Injectable Solution
Indications for Use: Xylazine Reversing Agent and Antidote For Use in Dogs Only
Date of Approval: September 26, 1989

NADA 140-867 original approval
Sponsor: American Cyanamid Company
Generic Name: salinomycin sodium + chlortetracycline + roxarsone
Trade Name: BIO-COX® + AUREOMYCIN® + 3-Nitro®
Indications for Use: For the prevention of coccidiosis in broiler chickens cause by susceptible organisms including some field strains of E. tenella that are more susceptible to roxarsone combined with salinomycin than salinomycin alone as an aid in the reduction of mortality due to E. coli infections susceptible to such treatment.
Date of Approval: June 12, 1989

NADA 140-869 original approval
Sponsor: Purina Mills, Inc.
Generic Name: medicated feed block containing 6.6% poloxalene
Trade Name: Purina Bloat Block
Indications for Use: For control of legume (alfalfa, clover) and wheat pasture bloat in cattle when consumed at the prescribed rate.
Date of Approval: August 8, 1989

NADA 140-872 original approval
Sponsor: Animal Sciences Division of Monsanto Company
Generic Name: Recombinant DNA-derived methionyl bovine somatotropin
Trade Name: POSILAC® (sterile sometribove zinc suspension)
Indications for Use: For increased production of marketable milk in lactating dairy cows.
Date of Approval: November 5, 1993

NADA 140-872 supplemental approval
Sponsor: Monsanto Company
Generic Name: Sometribove zinc suspension
Trade Name: Posilac 1 Step®
Effect of Supplement: A study was conducted to evaluate the effectiveness and animal safety of sometribove given by subcutaneous injection in the neck area.
Date of Approval: December 27, 2001

NADA 140-872 supplemental approval
Sponsor: Monsanto Company
Generic Name: Sometribove zinc suspension
Trade Name: Posilac 1 Step®
Effect of Supplement: This Freedom of Information Summary describes the basis for labeling changes to modify/remove precautions pertaining to target animal safety and reproduction.
Date of Approval: September 11, 2003

NADA 140-874 original approval
Sponsor: Wildlife Laboratories
Generic Name: yohimbine hydrochloride
Trade Name: Antagonil
Indications for Use: For the antagonism of xylazine sedation in free-ranging and confined members of the family Cervidae (deer and elk).
Date of Approval: February 3, 1993

NADA 140-879 original approval
Sponsor: Norden Laboratories
Generic Name: nystatin - neomycin sulfate - thiostrepton - triamcinolone - acetonide topical ointment
Trade Name: DERMA 4 Ointment
Indications for Use: DERMA 4 Ointment is particularly useful in the treatment of: (1) acute and chronic otitis of varied etiologies; (2) interdigital cysts in dogs and cat; (3) anal gland infections in dogs; (4) dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal (Candida albicans ) infection; and (5) eczematous, contact and seborrheic dermatitis. Additionally, DERMA 4 Ointment may be used as an adjunct in the treatment of dermatitis due to parasitic infestation.
Date of Approval: August 2, 1989

NADA 140-881 original approval
Sponsor: Biomed Laboratories
Generic Name: nitrofurazone soluble dressing
Trade Name: Nitrofurazone Soluble Dressing
Indications for Use: For the prevention or treatment of surface bacterial infections of wounds, burns and cutaneous ulcers of dogs, cats and horses (not for food use).
Date of Approval: May 11, 1990

NADA 140-883 original approval
Sponsor: MOBAY Corporation
Generic Name: Hyaluronate Sodium
Trade Name: Legend(TM) ™(Hyaluronate Sodium) Injectable Solution
Indications for Use: Legend Injectable Solution is indicated in the treatment of joint dysfunction of the carpus or fetlock in horses due to non-infectious synovitis associated with equine osteoarthritis.
Date of Approval: September 12, 1991

NADA 140-883 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: Hyaluronate sodium
Trade Name: LEGEND Multi Dose Injectable Solution
Effect of Supplement: Approval of the supplement will add a multiple dose vial containing the preservative benzyl alcohol.
Date of Approval: December 15, 2005

NADA 140-886 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: HEARTGARD-30 Chewables
Indications for Use: For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis ) up to a month after infection.
Date of Approval: July 3, 1989

NADA 140-889 original approval
Sponsor: A.H. ROBINS and Biocraft Laboratories, Inc.
Generic Name: nystatin, neomycin sulfate, thiostrepton, triamcinolone, acetonide ointment
Trade Name: Derm-Otic Ointment
Indications for Use: Derm-Otic Ointment (nystatin, neomycin sulfate, thiostrepton, triamcinolone acetonide ointment) is particularly useful in the treatment of acute and chronic otitis of varied etiologies, in interdigital cysts in cats and dogs, and in anal gland infections in dogs. The preparation is also indicated in the management of dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly those caused, complicated, or threatened by bacterial or candidal (Candida albicans ) infections. It is also of value in eczematous dermatitis, and as an adjunct in the treatment of dermatitis due
to parasitic infestation.
Date of Approval: November 21, 1989

NADA 140-890 original approval
Sponsor: The Upjohn Company
Generic Name: ceftiofur hydrochloride sterile suspension
Trade Name: EXCENEL® Sterile Suspension*
Indications for Use: EXCENEL® Sterile Suspension is indicated for the treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis Type 2.
Date of Approval: April 26, 1996

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Co
Generic Name: Ceftiofur hydrochloride
Trade Name: Excencel® Sterile Suspension
Effect of Supplement: The supplemental application dated 7/26/98 provides for the use of an intramuscular or subcutaneous route of administration for Excenel® Sterile Suspension in new species cattle. The application dated 08/18/98 provides a revised label warning statement against use in veal calves.
Date of Approval: July 26, 1998; August 18, 1998

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL® RTU Sterile Suspension
Effect of Supplement: This supplement provides a new indication, within the currently approved dose and duration, for use of ceftiofur hydrochloride sterile suspension (EXCENEL^® RTU Sterile Suspension) in cattle, for the treatment of acute metritis (0-14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Date of Approval: February 8, 2002

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL® RTU Sterile Suspension
Effect of Supplement: To make the following four changes to the product insert:
1. revise the current "Microbiology" section to a "Clinical Microbiology" section
2. revise the minimum inhibitory concentration (MIC) table to include new MIC data for ceftiofur
3. add a table listing acceptable quality control ranges for ceftiofur
4. revise the National Committee for Clinical Laboratory Standards reference at the end to the insert.
Date of Approval: December 12, 2003

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: ceftiofur hydrochloride
Trade Name: EXCENEL RTU Sterile Suspension
Effect of Supplement: For the treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis type 2.
Date of Approval: June 18, 2004

NADA 140-890 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: EXCENEL RTU Sterile Suspension
Effect of Supplement: To establish a 3-day pre-slaughter withdrawal period for cattle
Date of Approval: June 2, 2006

NADA 140-892 original approval
Sponsor: Syntex Animal Health
Generic Name: oxfendazole
Trade Name: Synanthic® Bovine Dewormer Paste, 18.5%
Indications for Use: Oxfendazole is indicated for use in cattle (excluding female dairy cattle of breeding age) for the removal and control of: Lungworms, Stomach  worms: Barberpole worms, Brown stomach worms, Small  stomach  worms Intestinal  worms: hookworms, small intestinal worm, tapeworms, nodular worms.
Date of Approval: June 29, 1993

NADA 140-893 original approval
Sponsor: Beecham Laboratories
Generic Name: Epsiprantel
Trade Name: CESTEX ®
Indications for Use: CESTEX® (epsiprantel) tablets are indicated for the removal of the following: Feline cestodes:Dipylidium caninumand Taenia taeniaeformis.Canine cestodes:Dipylidium caninumand Taenia pisiformis
Date of Approval: December 1, 1989

NADA 140-896 (INAD 4521) original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Gentamicin sulfate, clotrimazole, and betamethasone valerate
Trade Name: OTOMAX®
Indications for Use: OTOMAX is indicated for treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatisformerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
Date of Approval: June 9, 1993

NADA 140-897 original approval
Sponsor: Roussel UCLAF
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-S
Indications for Use: For increased rate of weight gain and improved feed efficiency in feedlot steers.
Date of Approval: November 27, 1991

NADA 140-897 supplemental approval
Sponsor: Roussel Uclaf
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-G
Effect of Supplement: Provides for the administration of REVALOR®-G in pasture steers (slaughter, stocker and feeder steers) for increased rate of weight gain.
Date of Approval: March 27, 1996

NADA 140-897 supplemental approval
Sponsor: Roussel Uclaf
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-G
Effect of Supplement: Provides for the administration of REVALOR®-G in pasture heifers (slaughter, stocker and feeder heifers) for increased rate of weight gain.
Date of Approval: July 2, 1996

NADA 140-897 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: trenbolone acetate and estradiol
Trade Name: REVALOR®-IS
Effect of Supplement: Provides for the use of an additional dose ear implant for steers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency.
Date of Approval: June 19, 2000

NADA 140-897 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Trenbolone Acetate and Estradiol
Trade Name: REVALOR–S, REVALOR-IS, REVALOR-G
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004

NADA 140-901 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: Polysulfated Glycosaminoglycan (PSGAG)
Trade Name: Adequan® i.m.
Indications for Use: Adequan® i.m. is recommended for the intramuscular treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses.
Date of Approval: November 11, 1989

NADA 140-901 supplemental approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: Polysulfated Glycosaminoglycan (PSGAG)
Trade Name: Adequan® i.m
Effect of Supplement: Effect of Supplement: This supplemental application amends the NADA to provide for the use of Adequan® i.m. in the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the hock joint in horses.
Date of Approval: September 12, 1996

NADA 140-904 original approval
Sponsor: Veterinary Research and Development, Inc.
Generic Name: copper disodium edetate
Trade Name: Bovi-Cu
Indications for Use: For use in beef cattle and beef calves to prevent copper deficiency alone on or in association with molybdenum toxicity.
Date of Approval: April 18, 1989

NADA 140-908 original approval
Sponsor: Lloyd, Inc.
Generic Name: Sulfamethazine USP
Trade Name: Veta-Meth™ (sulfamethazine)
Indications for Use: For the treatment of diseases caused by organisms sensitive to sulfamethazine such as bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) ...
Date of Approval: September 16, 1999

NADA 140-909 original approval
Sponsor: Norden Laboratories, Inc.
Generic Name: sulfamethazine bolus
Trade Name: Sulka-S ™Bolus
Indications for Use: For treatment of the following diseases caused by organisms susceptible to sulfamethazine: bacterial scours (colibacillosis) caused by Escherichia coli , necrotic pododermatitis (foot rot) and calf diphtheria caused by Fusobacterium necrophorum , bacterial pneumonia associated with Pasteurella spp. , and coccidiosis caused by Eimeria bovis and E. zurnii in ruminating beef and dairy calves.
Date of Approval: March 27, 1989

NADA 140-910 original approval
Sponsor: HESS & CLARK, INC.
Generic Name: nitrofurazone soluble powder
Trade Name: NFZ Wound powder
Indications for Use: For the prevention or treatment of surface bacterial infections of wounds, burns, skin ulcers and abscesses after incision. For use only on dogs, cats and horses (not for food use).
Date of Approval: July 17, 1989

NADA 140-912 original approval
Sponsor: Mobay Corporation
Generic Name: febantel
Trade Name: Rintal® Tabs Anthelmintic Tablets
Indications for Use: Rintal® Tabs Anthelmintic Tablets are indicated for the removal of the following nematode parasites: In Dogs and Puppies: Hookworms (Ancylosotoma caninum, Uncinaria stenocephala); Ascarids (Toxocara canis, Toxascaris leonina); Whipworms (Trichuris vulpis). In Cats and Kittens: Hookworms (ancylostoma tubaeforme); Ascarids (Toxocara cati).
Date of Approval: July 19, 1991

NADA 140-913 original approval
Sponsor: Mobay Corporation
Generic Name: Enrofloxacin
Trade Name: Baytril® Antibacterial Injectable Solution
Indications for Use: Baytril® (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs:Dermal infections (wounds and abscesses) caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae *, Proteus mirabilis, and Staphylococcus aureus; Respiratory infections (pneumonia, tonsillitis, rhinitis) caused by susceptible strains of Escherichia coliand Staphylococcus aureus. Urinary cystitis caused by susceptible strains of Escherichia coli, Proteus mirabilis and Staphylococcus aureus.
Date of Approval: May 4, 1990

NADA 140-913 supplemental approval
Sponsor: Bayer Corporation
Generic Name: enrofloxacin tablets and enrofloxacin injectable solution
Trade Name: Baytril® Antibacterial Tablets and Baytril® Antibacterial Injectable Solution
Effect of Supplement: Revises dosage frequency, indications, and limitations.
Date of Approval: June 18, 1997

NADA 140-915 original approval
Sponsor: Ciba-Geigy Animal Health
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR®
Indications for Use: Interceptor tablets are indicated for use in the prevention of heartworm disease caused by Dirofilaria immitis and control of adult hookworm infections caused by Ancylostoma caninum in dogs.
Date of Approval: June 14, 1990

NADA 140-915 supplemental approval
Sponsor: CIBA-GEIGY Animal Health
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR®
Effect of Supplement: Approval of the supplemental NADA will change NADA No. 140-915 by adding indications for the removal and control of adult Toxocara canis (roundworm) and Trichuris vulpis (whipworm) infections in dogs over eight weeks of age. Data supporting efficacy for the roundworm and whipworm indications is contained in this supplemental NADA. The supplemental application does not propose any changes in the formulation, dosage forms, manufacturing procedures, recommended dosages or treatment regiment for INTERCEPTOR (milbemycin oxime).
Date of Approval: December 29, 1992

NADA 140-915 supplemental approval
Sponsor: Ciba-Geigy Corporation
Generic Name: milbemycin oxime tablets
Trade Name: INTERCEPTOR Flavor Tabs
Effect of Supplement: Approval of the supplemental NADA will change NADA No. 140-915 by adding indications for the use of INTERCEPTOR (milbemycin oxime) Flavor Tabs in puppies four weeks of age or greater and two pounds of body weight or greater (from greater than eight weeks of age). The supplemental application does not propose any changes in the formulation, dosage forms, manufacturing procedures, recommended dosages or monthly treatment regimen for INTERCEPTOR (milbemycin oxime) Flavor Tabs.
Date of Approval: August 16, 1995

NADA 140-915 supplemental approval
Sponsor: Ciba-Geigy Corporation
Generic Name: Milbemycin Oxime Tablets
Trade Name: Interceptor®
Effect of Supplement: This supplement expands the indications to include the removal and control of adult roundworms Toxascaris leonina. Laboratory data support the efficacy of the drug against this species.
Date of Approval: Sep. 9, 1996

NADA 140-915 supplemental approval
Sponsor: Novartis Animal Health
Generic Name: milbemycin oxime
Trade Name: INTERCEPTOR® FLAVOR TABS® for cats
Effect of Supplement: Approval of this supplemental NADA will change NADA 140-915 by adding an additional species (cat) to the label. The supplemental application also provides for changes in the dosage and indications for the cat only. No changes are made in the dosage form, dosages or treatment regimen for the dog. The cat will have labeling separate from the dog approval.
Date of Approval: March 10, 1998

NADA 140-915 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin Oxime Tablets
Trade Name: Safeheart™
Effect of Supplement: For the prevention of heartworm disease caused by Dirofilaria immitis in dogs and puppies four weeks of age or greater and 2 pounds of body weight or greater.
Date of Approval: June 4, 1998

NADA 140-916 original approval
Sponsor: Fermenta Animal Health Company
Generic Name: tiamulin
Trade Name: DENAGARD ® Liquid Concentrate
Indications for Use: For the treatment of swine dysentery associated with Treponema hyodysenteriae and swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.
Date of Approval: Jan 29, 1993

NADA 140-918 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: halofuginone hydrobromide, bambermycins
Trade Name: Stenorol®, Flavomycin®
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain in growing turkeys.
Date of Approval: March 22, 1996

NADA 140-919 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: halofuginone hydrobromide; bacitracin methylene disalicylate
Trade Name: Stenorol®, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagimitis, and E. gallopavonis; and for increased rate of weight gain in growing turkeys.
Date of Approval: Jan 29, 1993

NADA 140-921 original approval
Sponsor: VET-A-MIX, Inc.
Generic Name: Prednisolone, USP oral tablet 5.0 mg
Trade Name: PrednisTab™
Indications for Use: PrednisTab™ is intended for use in dogs. The indications for PrednisTab™ are the same as those for other anti-inflammatory steroids and comprise the various collagen, dermal, allergic, ocular, otic, and musculoskeletal conditions known to be responsive to the anti-inflammatory corticosteroids.
Date of Approval: November 8, 1991

NADA 140-921 supplemental approval
Sponsor: Lloyd, Incorporated
Generic Name: prednisolone, USP
Trade Name: PrednisTab®
Effect of Supplement: Provides for a new 20 mg tablet size.
Date of Approval: November 20, 1997

NADA 140-926 original approval
Sponsor: Elanco Animal Health, Division of Eli Lilly & Co.
Generic Name: Narasin/nicarbazin, bacitracin, methylene, disalicylate
Trade Name: Maxiban®/BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: January 4, 1999

NADA 140-927 original approval
Sponsor: Intervet America, Inc.
Generic Name: chorionic gonadotropin
Trade Name: CHORULON®
Indications for Use: CHORULON is indicated for the intramuscular use in cows for the treatment of nymphomania (frequent or constant heat) due to cystic ovaries.
Date of Approval: November 22, 1991

NADA 140-927 supplemental approval
Sponsor: Intervet Inc.
Generic Name: chorionic gonadotropin
Trade Name: Chorulon®
Effect of Supplement: Provides for the use of chorionic gonadotropin (Chorulon® ) as an aid in improving spawning function in male and female brood finfish.
Date of Approval: August 6, 1999

NADA 140-929 original approval
Sponsor: Elanco Animal Health
Generic Name: Tilmicosin Phosphate
Trade Name: MICOTIL® 300
Indications for Use: For the treatment of respiratory disease (BRD) associated with Pasteurella haemolytica in cattle.
Date of Approval: March 3, 1992

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin injection USP
Trade Name: Micotil® 300
Effect of Supplement: Provides for the use of tilmicosin phosphate (Micotil® 300) in cattle for a new therapeutic claim.
Date of Approval: December 30, 1996

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Micotil® 300 Injection
Effect of Supplement: Deletes the following statements from the label: "A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal."
Date of Approval: December 23, 1997

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Micotil® 300 Injection
Effect of Supplement: This supplemental application provides for the addition of a new species, sheep.
Date of Approval: September 4, 2002

NADA 140-929 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Tilmicosin phosphate
Trade Name: MICOTIL 300
Effect of Supplement: To provide user safety information on the product labeling related to the mechanism of toxicity and medical intervention.
Date of Approval: December 2, 2005

NADA 140-934 original approval
Sponsor: SmithKline Beecham Animal Health
Generic Name: Albendazole
Trade Name: VALBAZEN®
Indications for Use: For the removal and control of the following endoparasites infecting sheep: A.Liver flukes;
B.Tapeworms; C.Lungworms; D.Stomach worms; E.Intestinal worms
Date of Approval: November 10, 1994

NADA 140-937 original approval
Sponsor: Elanco Animal Health
Generic Name: Monensin Sodium, Bacitracin Methylene Disalicylate
Trade Name: COBAN®, and BMD®, No Trade Name Proposed for Combination
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: November 18, 1994

NADA 140-937 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: monensin sodium, bacitracin methylene disalicylate
Trade Name: COBAN®, BMD®
Effect of Supplement: This supplemental application provides for a new combination including bacitracin methylene disalicylate, as an aid in the control of transmissible enteritis complicated by susceptible organisms at a new use level, when used in Type C medicated feeds in combination with monensin for the prevention of coccidiosis.
Date of Approval: August 13, 1998

NADA 140-940 original approval
Sponsor: Pfizer Inc.
Generic Name: semduramicin sodium
Trade Name: AVIAX®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix and E. mivati/mitis.
Date of Approval: March 10, 1994

NADA 140-942 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Narasin and nicarbazin, bambermycins
Trade Name: Maxiban® plus Flavomycin®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: March 8, 2001

NADA 140-947 original approval
Sponsor: Elanco Animal Health
Generic Name: Narasin/nicarbazin
Trade Name: Mexiban®, Lincomix®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increase in rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: September 3, 1998

NADA 140-951 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: Diclazuril
Trade Name: Clinacox ™
Indications for Use: For the prevention of coccidiosis by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (E. mivati), and E. maxima In broiler chicken.
Date of Approval: April 21, 1999

NADA 140-951 original approval
Sponsor: Schering-Plough Aminal Health
Generic Name: Diclazuril
Trade Name: Clinacox ™
Indications for Use: Broiler Chickens:
For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.
Date of Approval: September 21, 2001

NADA 140-954 original approval
Sponsor: Hoechst-Roussel Agri-Vet Company
Generic Name: fenbendazole, lincomycin
Trade Name: Lincomix®, Type “A” Medicated Article (Premix)
Indications for Use: Fenbendazole is indicated for the removal of: LUNGWORMS; GASTROINTESTINAL WORMS; KIDNEYWORMS ..1. increased rate of weight gain in growing-finishing swine 2. for control of swine dysentery; for use in swine on premises with a history of swine dysentery, but where symptoms have not yet occurred 3. for treatment swine dysentery  4. for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae.
Date of Approval: July 9, 1992

NADA 140-955 original approval
Sponsor: Elanco Animal Health
Generic Name: Monensin, Bambermycin
Trade Name: COBAN®, FLAVOMYCIN®
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: June 28, 2000

NADA 140-958 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: phenylbutazone paste
Trade Name: Equiphen Paste
Indications for Use: For relief of inflammatory conditions associated with the musculoskeletal system in horses.
Date of Approval: May 14, 1993

NADA 140-971 original approval
Sponsor: Merck Research Laboratories
Generic Name: ivermectin and pyrantel (as pamoate salt)
Trade Name: HEARTGARD-30® Plus
Indications for Use: Ivermectin (To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for a month (30 days) after infection), pyrantel pamoate (for the treatment and control of adult Toxocara canis, Toxascaris leonina, Ancylostoma caninum and Uncinaria stenocephala) in dogs.
Date of Approval: January 15, 1993

NADA 140-971 supplemental approval
Sponsor: Merck Research Laboratories
Generic Name: ivermectin; pyrantel (as pamoate salt)
Trade Name: Heartgard™ Plus
Effect of Supplement: This supplement expands the indications to include the treatment and control of adult hookworms (Ancylostoma braziliense).
Date of Approval: October 3, 1996

NADA 140-973 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: clenbuterol hydrochloride
Trade Name: VENTIPULMIN® SYRUP
Indications for Use: Ventipulmin^® Syrup (clenbuterol hydrochloride) is indicated for use in the management of horses affected with airway obstruction, such as occurs in chronic obstructive pulmonary disease (COPD).
Date of Approval: May 11, 1998

NADA 140-974 original approval
Sponsor: Merck Sharp & Dohme Research Laboratories
Generic Name: ivermectin
Trade Name: IVOMEC® Premix for Swine
Indications for Use: For the treatment and control of GASTROINTESTINAL ROUNDWORMS; KIDNEYWORMS; LUNGWORMS; lice and mange mites when incorporated into complete swine feeds.
Date of Approval: September 23, 1993

NADA 140-974 supplemental approval
Sponsor: Merck Research Laboratories
Generic Name: Ivermectin
Trade Name: IVOMEC® Premix for Swine
Effect of Supplement: To add the label claim for treatment of breeding swine.
Date of Approval: July 27, 1995

NADA 140-974 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: IVOMEC® Premix for Swine;
Effect of Supplement: New claim for the treatment and control of threadworms (Strongyloides ransomi, adults and somatic larvae, and prevention of transmission of infective larvae to piglets via the colostrum or milk, when fed during gestation) and use of Type C medicated feed as a top dress for adult swine.
Date of Approval: August 10, 1998

NADA 140-976 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: neomycin sulfate
Trade Name: Neomix® 325 Medicated Premix / Neomix® AG 325 Medicated Premix
Effect of Supplement: Provides for the finalization of NAS/NRC/DESI review of Neomycin Sulfate Type A Medicated Articles.
Date of Approval: November 3, 1999

NADA 140-988 original approval
Sponsor: Merck Research Laboratories
Generic Name: Ivermectin
Trade Name: IVOMEC® SR Bolus for Cattle
Indications for Use: The Ivomec® SR Bolus is indicated for (1) the treatment of established infections and, throughout its approximately 135-day invermectin delivery period, prevents the establishment of infection by newly ingested larvae of certain nematode species, (2) treatment of established infections of certain mange mites, (3) treatment of established infections of certain sucking lice, (4) control of existing Hypoderma larvae or grubs and newly acquired larvae during the 135-day period, and (5) control of the tick Amblyomma americanum by interfering with engorgement with blood and completion of the reproductive portion of the young adult female life cycle.
Date of Approval: November 18, 1996

NADA 140-988 supplemental approval
Sponsor: Merial Limited
Generic Name: ivermectin
Trade Name: Ivomec® SR Bolus for Cattle
Effect of Supplement: Provides for reducing the predicted duration of effectiveness from "approximately 135 days" to "approximately 130 days".
Date of Approval: June 21, 2000

NADA 140-989 original approval
Sponsor: Western Chemical, Inc.
Generic Name: formalin
Trade Name: PARASITE-S®
Indications for Use: A. Formalin is indicated for the control of external parasites on cultured food fishes: salmon, trout, catfish, largemouth bass, and bluegill sunfish. Organisms controlled include the protozoa: Ichthyophthirius spp. ("Ich"), Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp. and monogenetic trematodes: Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp.; B. For control of fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs.
Date of Approval: July 31, 1992

NADA 140-989 supplemental approval
Sponsor: Western Chemical Inc.
Generic Name: formalin
Trade Name: PARASITE-S®
Effect of Supplement: To add a new species, new claims, new dosages, and new treatment regimens.
Date of Approval: September 30, 1993

NADA 140-989 supplemental approval
Sponsor: Western Chemical, Inc.
Generic Name: Formalin
Trade Name: Parasite-S
Effect of Supplement: The approval will allow for the use of formalin to be expanded, as aparasiticide, to all finfish, and, as a fungicide, to the eggs of all finfish.
Date of Approval: June 18, 1998

NADA 140-992 original approval
Sponsor: Roussel Uclaf
Generic Name: trenbolone acetate and estradiol
Trade Name: Revalor®-H
Indications for Use: For increased rate of weight gain and improved feed efficiency in heifers fed in confinement for slaughter.
Date of Approval: December 13, 1994

NADA 140-992 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-200
Effect of Supplement: This supplemental application provides for the use of a higher dose ear implant for steers fed in confinement for slaughter for increased rate of weight gain and improved feed efficiency.
Date of Approval: November 29, 1999

NADA 140-992 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-IH
Effect of Supplement: Provides for the administration of a dose of 80 mg trenbolone acetate and 8 mg estradiol in heifers fed in confinement for slaughter for increased rate of weight gain.
Date of Approval: June 19, 2000

NADA 140-992 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: Revalor®-200
Effect of Supplement: Provides for the administration of REVALOR®-200
to heifers fed in confinement for slaughter.
Date of Approval: December 6, 2001

NADA 140-992 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Trenbolone acetate, estradiol
Trade Name: REVALOR-H, REVALOR-IH, Revalor®-200
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: October 28, 2004

NADA 140-994 original approval
Sponsor: Lloyd, Inc.
Generic Name: Tolazoline Hydrochloride, USP, Sterile Solution
Trade Name: Tolazine™Injection
Indications for Use: Tolazine should be used in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine.
Date of Approval: April 19, 1996

NADA 140-998 original approval
Sponsor: SmithKline Beecham Animal Health
Generic Name: virginiamycin
Trade Name: V-Max™
Indications for Use: For increased rate of weight gain, for improved feed efficiency, and for reduction in the incidence of liver abscesses in cattle fed in confinement for slaughter.
Date of Approval: June 24, 1994

NADA 140-999 original approval
Sponsor: Orion Corporation
Generic Name: medetomidine hydrochloride
Trade Name: Domitor®
Indications for Use: Domitor is indicated for use as a sedative and analgesic in dogs over 12 weeks of age, to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The IV route of administration is more efficacious for dental care.
Date of Approval: March 19, 1996

NADA 141-002 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Oxytetracycline hydrochloride
Trade Name: OXY 500 Calf Bolus / OXY 1000 Calf Bolus
Indications for Use: For the control and treatment of the following diseases of beef and dairy calves caused by organisms sensitive to oxytetracycline; bacterial entertis caused by Salmonella typhimurium and Escherichia coli (colibacillosis); bacterial pneumonia (shipping fever complex, pasteurellosis) caused by Pasteurella multocida.
Date of Approval: October 26, 1998

NADA 141-007 original approval
Sponsor: Miles, Inc.
Generic Name: praziquantel + pyrantel Pamoate + febantel
Trade Name: Drontal™ Plus Broad Spectrum Anthelmintic Tablets
Indications for Use: Drontal™ Plus Broad Spectrum Anthelmintic Tablets are indicated for the removal of tapeworms, hookworms, ascarids, whipworms in dogs.
Date of Approval: May 19, 1994

NADA 141-007 supplemental approval
Sponsor: Bayer Corporation
Generic Name: Praziquantel + Pyrantel Pamoate + Febantel
Trade Name: Drontal™ Plus Broad Spectrum Anthelmintic Tablets
Effect of Supplement: This supplemental application amends NADA 141-007, Drontal™ Plus Broad Spectrum Anthelmintic Tablets, by adding the tape-worm Echinococcus multilocularis claim to the label.
Date of Approval: March 28, 1996

NADA 141-007 supplemental approval
Sponsor: Bayer Corporation Agricultural Division
Generic Name: Praziquantel + Pyrantel Pamoate + Febantel
Trade Name: Drontal™ Plus Broad Spectrum Anthelmintic Tablets
Effect of Supplement: Effect of Supplement: This supplement amends the NADA to provide for a larger tablet containing 136.0 mg praziquantel, 136.0 mg pyrantel base as pyrantel pamoate and 680.4 mg febantel and the associated label changes.
Date of Approval: February 10, 2003

NADA 141-007 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: praziquantel/pyrantel pamoate/febantel
Trade Name: DRONTAL Plus TASTE TABS
Effect of Supplement: This supplement amends the approved NADA by adding a flavored tablet formulation with the same indications.
Date of Approval: January 12, 2006

NADA 141-008 original approval
Sponsor: Miles Inc.
Generic Name: praziquantel + pyrantel pamoate
Trade Name: Drontal™ Tablets
Indications for Use: Drontal Tablets will remove Tapeworms (Dipylidium caninum, Taenia taeniaeformis ), Hookworms (Ancylostoma tubaeforme ) and Large Roundworms (Toxocara cati ) in kittens and cats.
Date of Approval: September 29, 1993

NADA 141-017 original approval
Sponsor: Abbott Laboratories
Generic Name: sarafloxacin hydrochloride
Trade Name: Saraflox® WSP
Indications for Use: Saraflox® WSPis indicated in growing broiler chickens and growing turkeys for the control of mortality associated with E. coli organisms sensitive to sarafloxacin hydrochloride.
Date of Approval: August 18, 1995

NADA 141-018 original approval
Sponsor: Abbott Laboratories
Generic Name: sarafloxacin hydrochloride
Trade Name: SaraFlox® Injection
Indications for Use: SaraFlox® Injection is indicated for control of early mortality associated with Escherichia coli (colibacillosis) susceptible to sarafloxacin in day-old broiler chickens.
Date of Approval: March 28, 1996

NADA 141-018 supplemental approval
Sponsor: Abbott Laboratories
Generic Name: sarafloxacin hydrochloride
Trade Name: SaraFlox® Injection
Effect of Supplement: This supplement provides for the addition of a new dose for in ovo administration to 18-day embryonated broiler eggs, to be added to the previously approved product, SaraFlox® Injection.
Date of Approval: January 21, 1997

NADA 141-025 original approval
Sponsor: Syntex Animal Health
Generic Name: laidlomycin propionate potassium
Trade Name: Cattlyst®
Indications for Use: For increased rate of weight gain and improved feed efficiency of cattle fed in confinement for slaughter.
Date of Approval: March 4, 1994

NADA 141-025 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: laidlomycin propionate potassium
Trade Name: Cattlyst®
Effect of Supplement: Codification of Acceptable Daily Intake (ADI) and establishment of a Tolerance for residues.
Date of Approval: May 12, 2003

NADA 141-026 original approval
Sponsor: Ciba Animal Health
Generic Name: lufenuron suspension
Trade Name: Program® Suspension
Indications for Use: Program® Suspension is indicated for use in cats, six weeks of age and older, for the control of flea populations.
Date of Approval: March 28, 1995

NADA 141-026 supplemental approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron suspension
Trade Name: Program® Suspension
Effect of Supplement: Change from Rx to Over the Counter and addition of an Adverse Reactions section to the product label.
Date of Approval: December 31, 1996

NADA 141-029 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: desoxycorticosterone pivalate
Trade Name: Percorten™-V
Indications for Use: For use as a replacement therapy for the mineralocoricoid dificit in dogs with primary adrenocortical insufficiency.
Date of Approval: January 12, 1998

NADA 141-033 original approval
Sponsor: Pfizer
Generic Name: atipamezole hydrochloride
Trade Name: Antisedan®
Indications for Use: ANTISEDAN ® is indicated for the reversal of the clinical effects of the sedative and analgesic agent, DOMITOR® (medetomidine hydrochloride), in dogs.
Date of Approval: August 6, 1996

NADA 141-033 supplemental approval
Sponsor: Orion Corporation
Generic Name: atipamezole hydrochloride
Trade Name: ANTISEDAN
Effect of Supplement: An additional indication for the reversal of the sedative and analgesic effects of DEXDOMITOR (dexmedetomidine hydrochloride).
Date of Approval: December 1, 2006

NADA 141-034 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Flavomycin®
Effect of Supplement: A previous approval (58 FR 54286; October 21, 1993) provided for the use of bambermycins in complete feeds for increased rate of weight gain and improved feed efficiency of cattle fed in confinement for slaughter. This approval provides for the same dosage range of 10 to 20 mg bambermycins/head/day for increased rate of weight gain in pasture cattle (slaughter, stocker and feeder cattle) when fed daily in a least one pound of supplemental feed (Type C Medicated feed).
Date of Approval: March 14, 1994

NADA 141-034 supplemental approval
Sponsor: Hoechst-Roussel Agri-Vet Co.
Generic Name: bambermycins
Trade Name: Gainpro™
Effect of Supplement: 21 CFR 558.95 currently provides for the use of bambermycins in cattle fed in confinement for slaughter for improved feed efficiency and increased rate of weight gain, and for increased rate of weight gain in pasture cattle. This supplement provides for use of a generic formulation of loose mineral free-choice Type C medicated feed for free-choice supplementation to pasture cattle.
Date of Approval: July 9, 1996

NADA 141-034 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: Bambermycins
Trade Name: GAINPRO ™
Effect of Supplement: 21 CFR 558.95 currently provides for the use of bambermycins in cattle fed in confinement for slaughter for improved feed efficiency and increased rate of weight gain, and for increased rate of weight gain in pasture cattle. This supplement provides for use of loose mineral free-choice Type C medicated feed (Trade Name: Vigortone GP Grazer) for free-choice supplementation to pasture cattle.
Date of Approval: March 10, 1998

NADA 141-034 supplemental approval
Sponsor: Hoechst Roussel Vet
Generic Name: Bambermycins
Trade Name: GAINPRO ™
Effect of Supplement: provides for the removal of the caution statement "Not for Use in Animals Intended for Breeding" in feedlot and pasture cattle, and the addition of dairy and beef replacement heifers to the indications for use in pasture cattle.
Date of Approval: June 29, 1998

NADA 141-034 supplemental approval
Sponsor: Intervet, Inc.
Generic Name: Bambermycins
Trade Name: GAINPRO ™
Effect of Supplement: To provide for free-choice and hand-fed consumption of bambermycins at a rate of not less than 10 mg nor more than 40 mg per head per day to increase rate of weight gain in pasture cattle.
Date of Approval: February 10, 2003

NADA 141-035 original approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron tablets
Trade Name: PROGRAM® Tablets
Indications for Use: PROGRAM Tablets are indicated for use in dogs, six weeks of age and older, for the prevention and control of flea populations.
Date of Approval: November 23, 1994

NADA 141-035 supplemental approval
Sponsor: Ciba Animal Health, Ciba-Geigy Corporation
Generic Name: lufenuron tablets
Trade Name: Program® Tablets
Effect of Supplement: Change from Rx to Over the Counter and addition of an Adverse Reactions section to the product label.
Date of Approval: December 31, 1996

NADA 141-035 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: lufenuron
Trade Name: Program® Cat Tabs
Effect of Supplement: Approval of the supplemental NADA will change NADA 141-035 by adding the indication for the use of lufenuron tablets in cats and kittens, six weeks of age or older, at a minimum dose of 30 mg/kg for the control of flea populations. The cat [sic] will have labeling separate from the original dog approval.
Date of Approval: January 23, 1997

NADA 141-035 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron Tablets
Trade Name: Program® Flavor Tabs™
Effect of Supplement: This supplemental provides for adding a flavored tablet formulation with the same indications as the non-flavored tablets.
Date of Approval: August 1, 1998

NADA 141-035 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron
Trade Name: Program® Flavor Tabs™
Effect of Supplement: This supplemental application provides for labeling changes reflecting the concurrent use with Capstar® (nitenpyram) Tablets (NADA 141-175) and reflecting a decrease in the minimum age from 6 weeks to 4 weeks.
Date of Approval: June 11, 2003

NADA 141-036 original approval
Sponsor: The Upjohn Company
Generic Name: pirlimycin hydrochloride aqueous gel
Trade Name: Pirsue™ Aqueous Gel
Indications for Use: Pirlimycin is indicated for the treatment of clinical and subclinical mastitis in lactating dairy cattle. Pirlimycin has been proven effective only against Staphylococcus species such as Staphylococcus aureus and Streptococcus species such as Streptococcus agalactiae, Stretococcus dysgalactiae, and Streptococcus uberis. Cows with systemic clinical signs caused by mastitis should receive other appropriate therapy under the direction of a licensed veterinarian.
Date of Approval: September 10, 1993

NADA 141-036 supplemental approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: pirlimycin hydrochloride
Trade Name: PIRSUE® Sterile Solution
Effect of Supplement: Provides for a new sterile formulation with the same therapeutic claims. Also, provides for an Acceptable Daily Intake, a tolerance in cattle muscle, and a 9-day pre-slaughter withdrawal period.
Date of Approval: September 7, 2000

NADA 141-036 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Pirlimycin hydrochloride
Trade Name: PIRSUE Sterile Solution
Effect of Supplement: This supplement provides for an extended duration of therapy dosage regimen.
Date of Approval: December 12, 2007

NADA 141-038 original approval
Sponsor: Luitpold Pharmaceuticals, Inc.
Generic Name: polysulfated glycosaminoglycan (PSGAG)
Trade Name: Adequan® Canine
Indications for Use: Intramuscular injection for the control of signs associated with non-infectious degenerative and/or traumatic arthritis of canine synovial joints.
Date of Approval: July 15, 1997

NADA 141-040 original approval
Sponsor: PR Pharmaceuticals, Inc.
Generic Name: Estradiol benzoate
Trade Name: Celerin™
Indications for Use: For increased rate of weight gain and improved feed efficiency in steers and in heifers which will not be used for reproduction.
Date of Approval: June 25, 2003

NADA 141-040 supplemental approval
Sponsor: PR Pharmaceuticals, Inc.
Generic Name: Estradiol benzoate
Trade Name: CELERIN
Effect of Supplement: This supplement provides for the addition of the suckling beef calf indication “For increased rate of weight gain,” originally approved under NADA 141-041 as CELERIN C to CELERIN. In addition it updates the dosage administration for suckling beef calves to 0.5 mL (10 mg). This supplement also provides for a change in the indication and dosage to allow use for increased rate of weight gain in steers fed in confinement for slaughter, previously at 10 mg (0.5 mL) to 20 mg (1.0 mL). In addition, this supplement also provides for a new 10 mL vial size.
Date of Approval: January 19, 2006

NADA 141-041 original approval
Sponsor: PR Pharmaceuticals, Inc.
Generic Name: Estradiol benzoate
Trade Name: Celerin™ C
Indications for Use: For increased rate of weight gain in calves at least 30 days old which will not be used for reproduction and not used for veal.
Date of Approval: June 25, 2003

NADA 141-043 original approval
Sponsor: Syntex Animal Health, Division of Syntex Agribusiness, Inc.
Generic Name: trenbolone acetate and estradiol benzoate
Trade Name: Synovex® Plus
Indications for Use: For improved feed efficiency in steers fed in confinement for slaughter.
Date of Approval: February 22, 1996

NADA 141-043 supplemental approval
Sponsor: Fort Dodge Animal Health, Division of American Home Products Corp.
Generic Name: Trenbolone acetate and estradiol benzoate
Trade Name: Synovex® Plus
Effect of Supplement: provides for implanatation in steers fed in confinement for slaughter for increased rate of weight gain and the establishment of an ADI for trenbolone.
Date of Approval: March 16, 1999

NADA 141-043 supplemental approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name: Trenbolone acetate and estradiol benzoate
Trade Name: Synovex® Choice
Effect of Supplement: provides for use at an additional dosing level.
Date of Approval: October 3, 2002

NADA 141-043 supplemental approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name: Trenbolone Acetate and Estradiol Benzoate
Trade Name: SYNOVEX Choice and SYNOVEX PLUS
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established. ”immediately following the label indications.
Date of Approval: October 28, 2004

NADA 141-044 original approval
Sponsor: Peptech Animal Health Pty, Limited
Generic Name: Deslorelin Acetate
Trade Name: Ovuplant ™
Indications for Use: For inducing ovulation within 48 hours in estrous mares with an ovarian follicle greater than 30 mm in diameter.
Date of Approval: June 18, 1998

NADA 141-047 original approval
Sponsor: Fort Dodge Laboratories
Generic Name: butorphanol
Trade Name: Torbugesic-SA (butorphanol) Veterinary Injection
Indications for Use: Torbugesic-SA (butorphanol tartrate, USP) is indicated for the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
Date of Approval: July 5, 1994

NADA 141-051 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin heartworm prevention tablets
Trade Name: ProHeart™ for Dogs
Indications for Use: To prevent infections by the canine heartworm, Dilofilaria immitis, and the subsequent development of canine heartworm disease.
Date of Approval: May 27, 1997

NADA 141-052 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: 0.2% cyclosporine opthalmic ointment
Trade Name: Optimmune® Opthalmic Ointment
Indications for Use: For the treatment of chronic keratoconjunctivitis sicca (KCS) in dogs.
Date of Approval: August 2, 1995

NADA 141-052 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: 0.2% cyclosporine USP ophthalmic ointment
Trade Name: Optimmune® ophthalmic ointment
Effect of Supplement: To add the label claim for the management of chronic superficial keratitis (CSK) in dogs. In addition, the label claim for treatment of chronic keratoconjunctivis sicca (KCS) was changed to management of chronic KCS. The term management reflects the complexity of therapy for the two diseases.
Date of Approval: August 26, 1997

NADA 141-053 original approval
Sponsor: Pfizer Inc.
Generic Name: carprofen
Trade Name: Rimadyl®
Indications for Use: RIMADYL® is indicated for the relief of pain and inflammation in dogs. RIMADYL was shown to be clinically effective for the reflief of signs associated with osteoarthritis in dogs.
Date of Approval: October 25, 1996

NADA 141-053 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: carprofen
Trade Name: Rimadyl® Caplets
Effect of Supplement: This supplement provides for flexibility in administration of the total daily dose of Rimadyl® caplets. The drug may be administered orally at 2 milligrams per pound of body weight once daily or 1 milligram per pound of body weight twice daily.
Indications for Use: Rimadyl® is indicated for the relief of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: September 27, 2001

NADA 141-054 original approval
Sponsor: Merck Research Laboratories
Generic Name: Ivermectin and lincomycin
Trade Name: IVOMEC® Premix for Swine, Type A Medicated Article and LINCOMIX® Premix, Type A Medicated Article
Indications for Use: Ivermectin: For the treatment and control of gastrointestinal roundworms, kidneyworms, lungworms, lice and mange mites in swine. Lincomycin: for increased rate of weight gain, for treatment and control of swine dysentery, and for reduction in the severity of swine mycoplasmal pneumonia caused by Mycoplasma hyopneumoniae in swine.
Date of Approval: March 28, 1996

NADA 141-059 original approval
Sponsor: Alpharma, Inc.
Generic Name: bacitracin methylene disalicylate, chlortetracycline
Trade Name: BMD®-25, BMD®-30, BMD®-40, BMD®--50, BMD®-60, or BMD®-75 and CTC®50, CTC®65, CTC®70, or Micro-CTC®100
Indications for Use: Bacitracin methylene disalicylate Type A Medicated Articles (NADA 46-592): For increased rate of weight gain and improved feed efficiency. Chlortetracycline Type A Medicated Articles (NADA 46-699): For treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis, and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline.
Date of Approval: September 18, 1996

NADA 141-059 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: bacitracin methylene disalicylate chlortetracycline
Trade Name: BMD®10 BMD®25, BMD®30, BMD®40, BMD®50, BMD®60, or BMD®75 and CTC®50, CTC®65, CTC®70 Type A Medicated Articles
Effect of Supplement: This supplemental approval provides for using currently approved, single ingredient, Type A medicated articles in making combination drug Type B medicated swine feeds containing bacitracin methylene disalicylate and chlortetracycline.
Date of Approval: June 24, 1998

NADA 141-059 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: chlortetracycline (CTC), bacitracin methylene disalicylate (BMD)
Trade Name: ChlorMax™ 50, ChlorMax™ 65, or ChlorMax™ 70 and BMD® -25, BMD® -30, BMD® -40, BMD® -50, BMD® -60 or BMD® -75 Type A Medicated Articles
Effect of Supplement: adds the claim for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline to approved combination label indications.
Date of Approval: July 7, 2000

NADA 141-060 original approval
Sponsor: Alpharma, Inc.
Generic Name: Decoquinate
Trade Name: Deccox® -M Medicated Powder for Whole Milk
Indications for Use: DECCOX®-M is indicated for the prevention of coccidiosis caused by Eimeria bovis and E. zuernii in ruminating and non-ruminating calves, including veal calves.
Date of Approval: January 14, 1999

NADA 141-061 original approval
Sponsor: Pfizer Inc.
Generic Name: Doramectin 1% injectable solution
Trade Name: Dectomex® Injectable Solution
Indications for Use: For the treatment and control of certain nematode and arthropod parasites in cattle.
Date of Approval: July 30, 1996

NADA 141-061 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin 1% injectable solution
Trade Name: Dectomax® Injectable Solution
Effect of Supplement: New claims for persistent ocntrol of gastrointestinal roundworms and lungworms in cattle.
Date of Approval: July 18, 1997

NADA 141-061 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: doramectin 1% injectable solution
Trade Name: Dectomax® Injectable Solution
Effect of Supplement: Adds swine to the previously approved NADA.
Date of Approval: September 18, 1997

NADA 141-061 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: doramectin
Trade Name: Dectomax® 1% Injectable Solution For Cattle and Swine
Effect of Supplement: Provides for the addition of persistent efficacy to protect cattle from reinfection with Cooperia oncophora for 14 days and Oesophagostomum radiatum for 28 days after treatment.
Date of Approval: October 25, 1998

NADA 141-061 original approval
Sponsor: Pfizer Inc.
Generic Name: doramectin
Trade Name: Dectomax® 1% Injectable Solution For Cattle and Swine
Effect of Supplement: New indication for persistent control of nematodes in cattle adding protection against Haemonchus placei for 14 days after treatment.
Date of Approval: February 1, 1999

NADA 141-062 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: lufenuron
Trade Name: Program® Cat Flavor Tabs™
Indications for Use: Program Cat Flavor Tabs are indicated for use in cats and kittens, six weeks of age and older, for the control of flea populations.
Date of Approval: March 3, 1997

NADA 141-063 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: florfenicol
Trade Name: NUFLOR® Injectable Solution
Indications for Use: For the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, Pasteurella multocida,and Haemophilus somnus.
Date of Approval: May 31, 1996

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Label changes to standardize the veal calf residue warning and remove a graphic box from the Warnings section.
Date of Approval: April 2, 1998

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Provides for the use of a subcutaneous route of administration for Nuflor® Injectable Solution in cattle.
Date of Approval: June 4, 1998

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Provides for the use of florfenicol (Nuflor®Injectable Solution) as a single subcutaneous injection in cattle at high risk of developing bovine respiratory disease (BRD).
Date of Approval: December 17, 1998

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: NUFLOR® Injectable Solution
Effect of Supplement: Provides for the use of florfenicol (Nuflor®Injectable Solution) for treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis, infectious pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Date of Approval: January 14, 1999

NADA 141-063 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: NUFLOR Injectable Solution
Effect of Supplement: The effect of this supplement is to add information describing florfenicol’s in vitro bactericidal activity against some strains of Mannheimia haemolytica and Histophilus somni to the microbiology section of the product labeling.
Date of Approval: November 14, 2006

NADA 141-064 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly and Company
Generic Name: tilmicosin phosphate
Trade Name: Pulmotil® 90
Indications for Use: Pulmotil® 90 is indicated for the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.
Date of Approval: December 17, 1996

NADA 141-064 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Pulmotil® 90 Type A Medicated Article
Effect of Supplement: 1. The addition of the following caution statement to labeling.
“Caution: Do not allow horses or other equine access to feeds containing tilmicosin.”
2. The codification under 21 CFR 556.735, of an acceptable daily intake (ADI) in man and a muscle tolerance for parent tilmicosin in swine muscle.
Date of Approval: February 2, 1999

NADA 141-064 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: tilmicosin phosphate
Trade Name: Pulmotil® 90
Effect of Supplement: Changes to the label are 1) removal of the MIC chart; 2) additions to the Pharmacology section of the label; 3) additional CAUTION that discourages continuous use for more than 21 days and limits use of each VFD form to 90 days. Changes to the VFD are inclusion of the additional CAUTION like the label and 2) addition of a 90-day maximum for the expiration of the VFD.
Date of Approval: November 15, 2001

NADA 141-064 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Tilmicosin phosphate
Trade Name: PULMOTIL 90
Effect of Supplement: To allow for use in female breeding swine for the existing indication “For the control of swine respiratory disease associated with Actinobacillus pleuropneumoniae and Pasteurella multocida.”
Date of Approval: November 24, 2004

NADA 141-065 original approval
Sponsor: Pfizer Inc.
Generic Name: Semduramicin, Bacitracin methylene disalicylate
Trade Name: Aviax ™, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mivati/mitis, E. necatrix, and E. tenella, and for improved feed efficiency in broiler chickens.
Date of Approval: October 18, 1996

NADA 141-066 original approval
Sponsor: Pfizer Inc.
Generic Name: semduramicin, roxarsone
Trade Name: Aviax™, 3-Nitro®
Indications for Use: For the prevention of coccidiosis in broiler chickens caused by Eimeria acervulina, E. brunetti, E. mivati/mitis, E. necatrix, including some field strains of E. tenella that are more susceptible to semduramicin combined with roxarsone than semduramicin alone.
Date of Approval: November 7, 1997

NADA 141-067 original approval
Sponsor: Biopure Corporation
Generic Name: Hemoglobin glutamer-200 (bovine)
Trade Name: Oxyglobin
Indications for Use: Oxyglobin is indicated for the treatment of anemia in dogs by increasing systemic oxygen content (plasma hemoglobin concentration) and improving the clinical signs associated with anemia for at least 24 hours, regardless of the cause of anemia (hemolysis, blood loss, or ineffective erythropoiesis).
Date of Approval: January 12, 1998

NADA 141-067 supplemental approval
Sponsor: Biopure Corporation
Generic Name: Hemoglobin glutamer-200 (bovine)
Trade Name: Oxyglobin® Solution
Effect of Supplement: This supplement changes the original approval from a fixed dosage of 30 mL/kg to a flexible dosage range of 10-30 mL/kg.
Date of Approval: January 11, 2000

NADA 141-068 original approval
Sponsor: Bayer Corporation, Agriculture Division, Animal Health
Generic Name: Enrofloxacin
Trade Name: Baytril 100 Injectable Solution
Indications for Use: For the treatment of bovine respiratory disease (BRD) associated with Pasteurella haemolytica, Pasteurella multocida, and Haemophilus somnus.
Date of Approval: July 24, 1998

NADA 141-068 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: Enrofloxacin
Trade Name: BAYTRIL 100
Effect of Supplement: To provide for the use of enrofloxacin in female dairy cattle less than 20 months of age.
Date of Approval: February 13, 2008

NADA 141-068 supplemental approval
Sponsor: Bayer HealthCare LLC
Generic Name: Enrofloxacin
Trade Name: BAYTRIL 100
Effect of Supplement: This supplement provides a new indication, for the treatment and control of swine respiratory disease, in swine.
Date of Approval: March 14, 2008

NADA 141-069 original approval
Sponsor: Alpharma, Inc.
Generic Name: colistimethate sodium
Trade Name: FIRST GUARD STERILE POWDER
Indications for Use: FIRST GUARD STERILE POWDER (colistimethate sodium) is indicated for use in 1- to 3- day-old chickens for the control of early mortality associated with Escherichia coli susceptible to colistin.
Date of Approval: January 13, 1998

NADA 141-070 original approval
Sponsor: Mallinkrodt Veterinary, Inc.
Generic Name: propofol
Trade Name: Rapinovet®
Indications for Use: Rapinovet®is an anesthetic injection for use in dogs as follows: a) as a single injection to provide general anesthesia for procedures lasting up to five minutes; b) for induction and maintenance of general anesthesia using incremental doses to effect; and c) for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
Date of Approval: November 7, 1996

NADA 141-070 supplemental approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: propofol
Trade Name: Rapinovet®
Effect of Supplement: 1. The supplement supports the addition of a new species, cats, to the original approved dog application for the same anesthetic indications.
2. The supplement also contains changes to the original canine portions of the label and FOI Summary as follows:
a. Information concerning the use of medetomidine prior to propofol anesthesia in dogs will appear on the label as well as in the FOI Summary. Medetomidine is approved for use in dogs for sedation and analgesia.
b. The recommended preanesthetic medetomidine dose will be lowered from 10-40 ug/kg IM/IV to 5-10 ug/kg IM based on data already contained in the original new animal drug application (NADA) approval for propofol in dogs.
Date of Approval: January 14, 1999

NADA 141-071 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: imidocarb dipropionate
Trade Name: Imizol®
Indications for Use: For the treatment of babesiosis in dogs with clinical signs and/or demonstrated Babesia organisms in the blood.
Date of Approval: November 7, 1997

NADA 141-074 original approval
Sponsor: Wildlife Laboratories, Incorporated
Generic Name: naltrexone hydrochloride
Trade Name: Trexonil™
Indications for Use: For use as an antagonist to carfentanil citrate immobilization in free-ranging or confined elk and moose (Cervidae).
Date of Approval: December 23, 1996

NADA 141-075 original approval
Sponsor: Orphan Medical, Inc.
Generic Name: fomepizole
Trade Name: Antizol-Vet™ (fomepizole) for injection
Indications for Use: Antizol-Vet™ is indicated as an antidote for ethylene glycol (antifreeze) poisoning in dogs who have ingested or are suspected of having ingested ethylene glycol.
Date of Approval: November 25, 1996

NADA 141-077 original approval
Sponsor: Pharmacia & Upjohn Company
Generic Name: spectinomycin sulfate tetrahydrate
Trade Name: ADSPEC™ Sterile Solution
Indications for Use: ADSPEC™ Sterile Solution is indicated for the treatment of bovine respiratory disease (pneumonia) associated with Pasteurella haemolytica, Pasteurella multocida and Haemophilus somnus.
Date of Approval: January 28, 1998

NADA 141-078 original approval
Sponsor: Merck Research Laboratories
Generic Name: ivermectin
Trade Name: Heartgard® for Cats
Indications for Use: Heartgard® for Cats is indicated for the prevention of feline heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection, and for the removal and control of adult and immature (L4) hookworms (Ancylostoma tubaeforme and A. braziliense).
Date of Approval: December 23, 1996

NADA 141-079 original approval
Sponsor: Merck Research Laboratories
Generic Name: eprinomectin
Trade Name: Ivomec® Eprinex™ Pour-On
Indications for Use: For treatment and control of certain gastrointestinal nematodes, lungworms, cattle grubs, lice, mange mites, and flies.
Date of Approval: April 16, 1997

NADA 141-079 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Eprinomectin
Trade Name: Ivomec® Eprinex™ Pour-On for Beef and Dairy Cattle
Effect of Supplement: This supplemental application adds indications for the treatment and control of adult Strongyloides papillosus and adult Trichostrongylus longispicularis and removes the age restriction for use in cattle under 8 weeks of age
Date of Approval: August 9, 1998

NADA 141-080 original approval
Sponsor: Deprenyl Animal Health, Inc.
Generic Name: selegiline hydrochloride, the levorotatory form of deprenyl HCl
Trade Name: Anipryl®
Indications for Use: For the control of clinical signs associated with uncomplicated canine pituitary dependent hyperadrenocorticism (PDH).
Date of Approval: May 30, 1997

NADA 141-080 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: selegiline hydrochloride, the levorotatory form of deprenyl HCl
Trade Name: Anipryl®
Effect of Supplement: Provides for the addition of a new claim for the clinical signs associated with canine Cognitive Dysfunction Syndrome at a new dose of 0.5-1.0mg/kg.
Date of Approval: December 10, 1998

NADA 141-081 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: orbifloxacin
Trade Name: Orbax™
Indications for Use: For the management of diseases in dogs associated with bacteria susceptible to orbifloxacin; clinical efficacy was established in skin and soft tissue infections (wounds and abscesses) and urinary tract infections (cystitis) associated with bacteria susceptible to orbifloxacin.
Date of Approval: April 22, 1997

NADA 141-081 supplemental approval
Sponsor: Schering-Plough Animal Health
Generic Name: orbifloxacin tablets
Trade Name: Orbax™ tablets
Effect of Supplement: The supplement to NADA 141-081, for dogs, provides for revisions to 21 CFR 520.1616 and the use of Orbax (orbifloxacin) tablets in cats as indicated below.
§520.1616 Orbifloxacin tablets.
(d) Conditions of use. (1) Dogs and cats.
Date of Approval: September 18, 1997

NADA 141-081 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Orbifloxacin
Trade Name: ORBAX Tablets
Indications for Use: ORBAX Tablets (orbifloxacin) are indicated for the management of diseases in dogs and cats associated with bacteria susceptible to orbifloxacin.
Date of Approval: March 3, 2006

NADA 141-082 original approval
Sponsor: Heska Corporation
Generic Name: doxycycline hyclate
Trade Name: Heska™ Periodontal Disease Therapeutic
Indications for Use: The Heska Periodontal Disease Therapeutic is indicated for the treatment and control of periodontal disease in dogs.
Date of Approval: November 19, 1997

NADA 141-083 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid, Bacitracin Zinc
Trade Name: Avatec® plus Baciferm®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: April 18, 2001

NADA 141-084 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel™ Tablets
Indications for Use: For use in dogs and puppies four weeks of age and older and two pounds body weight or greater, for the prevention of heartworm disease caused by Dirofilaria immitis, for the prevention and control of flea populations, the control of adult Ancylostoma caninum (hookworm), and the removal and control of adult Toxocara canis, Toxocaris leonine (roundworm) and Trichuris vulpis (whipworm) infections.
Date of Approval: April 10, 1997

NADA 141-084 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel™ Flavor Tablets®
Effect of Supplement: Approval of this supplemental NADA will change NADA 141-084 by adding a flavored tablet formulation with the same indications. The flavored tablets (in three tablet sizes) will replace the swallow tablets for dogs ³ 11 pounds. The swallow tablet will remain for dogs between 2-10 lbs.
Date of Approval: June 17, 1998

NADA 141-084 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: milbemycin oxime/lufenuron tablets
Trade Name: Sentinel™ Flavor Tablets®
Effect of Supplement: Approval of this supplemental NADA will change the labeling for NADA 141-084.
1. There are some minor revisions to clarify the currently approved text in the package insert.
2. Use of the Client Information insert will be discontinued.
3. The package insert is revised to include reference to the concurrent use of CAPSTAR® (nitenpyram) Tablets (NADA 141-175) to kill adult fleas. The information supporting approval for this concurrent use is documented in NADA 141-204.
4. The unit dose cartons are revised to refer to concurrent use with CAPSTAR® Tablets.
5. Each unit dose carton will contain an additional “FLEA MANAGEMENT SYSTEM™” package insert that provides specific information for using CAPSTAR® Tablets with SENTINEL® Flavor Tabs®.
Date of Approval: June 11, 2003

NADA 141-085 original approval
Sponsor: Alpharma, Inc.
Generic Name: zoalene, bacitracin methylene disalicylate
Trade Name: ZOAMIX®,BMD®
Indications for Use: For the prevention and control of coccidiosis, for increased weight gain, and improved feed efficiency in growing turkeys.
Date of Approval: June 3, 1998

NADA 141-085 supplemental approval
Sponsor: Alpharma, Inc.
Generic Name: zoalene, bacitracin methylene disalicylate
Trade Name: Zoamix® , BMD®
Effect of Supplement: Provides for using approved single ingredient bacitracin methylene disalicylate and zoalene Type A medicated articles to make two-way combination drug Type C medicated feeds used for the management of necrotic enteritis and coccidiosis in replacement and broiler chickens.
Date of Approval: November 20, 2001

NADA 141-087 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: Quest™ moxidectin 2% Equine Oral Gel
Indications for Use: Quest^™ moxidectin 2% Equine Oral Gel, when administered at the recommended dose level of 0.4 mg moxidectin/kg (2.2 lb) body weight, has been demonstrated to be effective in the treatment and control of certain stages of gastrointestinal parasites of horses and ponies.
Date of Approval: July 11, 1997

NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of American Home Products
Generic Name: moxidectin
Trade Name: Quest™ 2% Equine Oral Gel
Effect of Supplement: a. New indication: For the treatment and control of Gasterophilus nasalis (3rd instars)
b. Labeling Change: The precautions section is revised to read “This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.” The photograph on the carton was changed to remove the picture of a young foal.
Date of Approval: October 4, 1999

NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: moxidectin
Trade Name: Quest™ Gel
Effect of Supplement: Raise the minimum age limit for use of this product from 4 months up to 6 months of age.
Date of Approval: May 29, 2003

NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: Quest® Gel
Indications for Use: For the treatment and control of the following stages of gastrointestinal parasites of horses and ponies six months of age and older which will not to be used for food: Large strongyles: Strongylus vulgaris (adult and L4/L5 arterial stages), Strongylus edentatus (adult and tissue stages), Triodontophorus brevicauda (adults), Triodontophorus serratus (adults) Small strongyles (adults): Cyathostomum spp. including C. catinatum, C. pateratum; Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus; Cylicostephanus spp. including C.calicatus, C. goldi, C. longibursatus, C. minutis; Coronocyclus spp., including C. coronatus, C. labiatus, C. labratus; Gyalocephalus capitatus; undifferentiated luminal larvae Encysted cyathostomes: late L3 and L4 mucosal cyathostome larvae Ascarids: Parascaris equorum (adults and L4 larval stages) Pinworms: Oxyuris equi (adults and L4 larval stages) Hairworms: Trichostrongylus axei (adults) Large-mouth stomach worms: Habronema muscae (adults) Horse stomach bots: Gasterophilus intestinalis (2nd and 3rd instars), G. nasalis (3rd instars) One dose also suppresses strongyles egg production for 84 days.
Date of Approval: March 17, 2004

NADA 141-087 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: QUEST Gel
Effect of Supplement: The supplement provides for the use of moxidectin gel for the treatment and control of adult Cylicocyclus radiatus and Petrovinema poculatus based on results from additional dose confirmation studies. 
Date of Approval: November 23, 2005

NADA 141-088 original approval
Sponsor: Alpharma, Inc.
Generic Name: Nitarsone, Bacitracin methylene disalicylate
Trade Name: HISTOSTAT®, BMD®
Indications for Use: As an aid in the prevention of blackhead, for increased weight gain, and improved feed efficiency in growing turkeys.
Date of Approval: June 17, 1998

NADA 141-090 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril; Virginiamycin
Trade Name: Clinacox ™, Stafac®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. For increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: January 13, 2000

NADA 141-095 original approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin 0.5% pour-on solution
Trade Name: Dectomax® Pour-On solution
Indications for Use: To control infections and to protect cattle from re-infection with Cooperia oncophora and Dictyocaulus viviparus for 21 days, and Ostertagia ostertagi, Cooperia puctata, and oesophagostomum radiatum for 28 days after treatment.
Date of Approval: September 16, 1997

NADA 141-095 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin
Trade Name: Dectomax® Pour-On solution for cattle
Effect of Supplement:  Adds to labeling a new indication for treatment and control of horn fly, Haematobia irritans
Date of Approval: October 25, 1998

NADA 141-095 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: doramectin
Trade Name: Dectomax® Pour-On
Effect of Supplement: Provides for addition of a therapeutic claim for Trichostrongylus axei L4 and a persistency claim of 35 days for Haemonchus placei.
Date of Approval: August 10, 1999

NADA 141-095 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Doramectin
Trade Name: DECTOMAX (doramectin) Pour-On
Effect of Supplement: For treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, lice, mange mites and horn flies. To protect cattle from reinfection with Cooperia oncophora, D. viviparus, Ostertagia ostertagi, and O.radiatum for 28 days; and with C. punctata, and Haemonchus placei for 35 days after treatment.
Date of Approval: June 30, 2004

NADA 141-095 supplemental approval
Sponsor: Pfizer, Inc
Generic Name: Doramectin
Trade Name: DECTOMAX Pour-On
Effect of Supplement: This supplement allows the following additional persistent effect indications. DECTOMAX Pour-On solution has been proved to effectively control infestations and to protect cattle from reinfestation with Bovicola (Damalinia) bovis for 77 days and Linognathus vituli for 42 days after treatment.
Date of Approval: June 23, 2005

NADA 141-096 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: difloxacin hydrochloride
Trade Name: Dicural® Tablets
Indications for Use: To manage diseases in dogs associated with bacteria susceptible to difloxacin.
Date of Approval: November 20, 1997

NADA 141-097 original approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin, bacitracin methylene disalicylate
Trade Name: Ivomec® Premix for Swine + BMD®
Indications for Use: For the treatment and control of gastrointestinal roundworms (Ascaris suum, adults and fourth-stage larvae; Ascarops strongylina, adults; Hyostrongylus rubidus, adults and fourth-stage larvae; Oesophagostomum spp., adults and fourth-stage larvae), kidneyworms (Stephanurus dentatus, adults and fourth-stage larvae), lungworms (Metastrongylus spp., adults), threadworms (Strongyloides ransomi, adults and somatic larvae and prevention of transmission of infective larvae to piglets, via the colostrum or milk, when fed during gestation), lice (Haematopinus suis), and mange mites (Sarcoptes scabiei var. suis).
Date of Approval: February 3, 1999

NADA 141-098
Sponsor: Abbott Laboratories
Generic Name: Propofol
Trade Name: PROPOFLO™
Indications for Use: a. For induction of anesthesia.
b. For maintenance of general anesthesia for up to 20 minutes.
c. For induction of general anesthesia where maintenance is provided by inhalant anesthetics.
Date of Approval: March 13, 1998

NADA 141-099 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: CYDECTIN® (moxidectin) 0.5% Pour-On for Cattle
Indications for Use: Effective in the treatment and control of external parasites. CYDECTIN® (moxidectin) 0.5% Pour-On for Cattle has been proven to effectively control infections and to protect cattle from reinfection with Ostertagia ostertagi for 28 days following treatment and Dictyocaulus viviparus for 42 days after treatment.
Date of Approval: January, 28, 1998

NADA 141-099 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: CYDECTIN® (moxidectin) 0.5% Pour-On for Cattle
Effect of Supplement: This supplemental application provides for topical use of a 0.5% moxidectin solution on dairy cattle of breeding age for treatment and control of infections and infestations of certain internal and external parasites. In addition, the regulations are amended to establish a tolerance for moxidectin residues in milk.
Date of Approval: November 2, 1999

NADA 141-099 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: moxidectin
Trade Name: CYDECTIN® (moxidectin) 0.5% Pour-On
Effect of Supplement: This supplemental application provides for treatment and control of infections of additional life stages and species of gastrointestinal roundworms for topical use of 0.5% moxidectin solution on cattle.
Date of Approval: June 18, 2001

NADA 141-100 original approval
Sponsor: Alpharma, Inc.
Generic Name: Decoquinate, bacitracin methylene disalicylate, roxarsone
Trade Name: DECCOX®,BMD®, 3-NITRO®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. nectrix, E. mivati, E. acervulina,
E. maxima, and E. brunetti, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed effeciency, and improved pigmentation in broiler chickens.
Date of Approval: June 2, 1998

NADA 141-101 original approval
Sponsor: BioScience
Generic Name: competitive exclusion culture
Trade Name: PREEMPT™
Indications for Use: PREEMPT™ is indicated for the early establishment of intestinal microflora in chickens to reduce Salmonella colonization.
Date of Approval: March 13, 1998

NADA 141-102 original approval
Sponsor: Alpharma Inc.
Generic Name: Decoquinate, Bacitracin methylene disalicylate
Trade Name: DECCOX®, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti, and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: July 24, 1998

NADA 141-103 original approval
Sponsor: Abbott Laboratories
Generic Name: Sevoflurane
Trade Name: SevoFlo™
Indications for Use: For induction and maintenance of general anesthesia.
Date of Approval: November 17, 1999

NADA 141-105 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Lufenuron 10% Sterile Suspension Injectable
Trade Name: Program 6 Month Injectable for Cats
Indications for Use: Program 6 Month Injectable for Cats is indicated for use in cats, six weeks of age and older, for the control of flea populations. Lufenuron controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Date of Approval: March 31, 1998

NADA 141-107 original approval
Sponsor: Alaco, Inc.
Generic Name: b -aminopropionitrile fumarate
Trade Name: BAPTEN® For Injection
Indications for Use: BAPTEN is indicated for the treatment of tendinitis of the superficial digital flexor tendon (SDFT) in the adult horse where there is sonographic evidence of fiber tearing.
Date of Approval: June 10, 1998

NADA 141-108 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: Etodolac
Trade Name: EtoGesic™
Indications for Use: Etodolac is recommended for the management of pain and inflammation associated with osteoarthritis in dogs
Date of Approval: July 22, 1998

NADA 141-108 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Etodolac
Trade Name: EtoGesic™
Effect of Supplement: This supplement allows for the addition of a 500 mg tablet.
Date of Approval: May 8, 2003

NADA 141-109 original approval
Sponsor: Roche Vitamins, Inc.
Generic Name: LASALOCID®, BACIFERM®
Trade Name: Lasalocid plus Bacitracin Zinc
Indications for Use: For the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: April 15, 1999

NADA 141-110 original approval
Sponsor: Elanco Animal Health
Generic Name: Monesin, virginiamycin
Trade Name: Coban®, Stafac®
Indications for Use: For the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis, and E. gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: January 29, 1999

NADA 141-111 original approval
Sponsor: Pfizer Inc.
Generic Name: Carprofen
Trade Name: Rimadyl® chewable tablets
Indications for Use: Rimadyl® chewable tablets are indicated for the relief of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: May 14, 1999

NADA 141-111 supplemental approval
Sponsor: Pfizer Inc.
Generic Name: Carprofen
Trade Name: Rimadyl® chewable tablets
Effect of Supplement: This supplement provides for flexibility in administration of the total daily dose of Rimadyl® Chewable Tablets. The drug may be administered orally at 2 milligrams per pound of body weight once daily or 1 milligram per pound of body weight twice daily
Indications for Use: Rimadyl® chewable tablets are indicated for the relief of pain and inflamation associated with osteoarthritis in dogs.
Date of Approval: November 26, 2001

NADA 141-112 original approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin/nicarbazin Bacitracin methylene disalicylate Roxarsone
Trade Name: Maxiban®, BMD®, 3-Nitro®
Indications for Use: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin; for increased rate of weight gain; improved feed efficiency, and improved pigmentation in broiler chickens.
Date of Approval: March 4, 1999

NADA 141-113 original approval
Sponsor: Elanco Animal Health, a Division of Eli Lilly and Co.
Generic Name: Narasin/nicarbazin Roxarsone
Trade Name: Maxiban®, 3-Nitro®
Indications for Use: For prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima; for increased rate of weight gain; improved feed efficiency, and improved pigmentation in broiler chickens.
Date of Approval: March 4, 1999

NADA 141-114 original approval
Sponsor: Pfizer, Inc.
Generic Name: Semduramicin, virginiamycin
Trade Name: Aviax™, Stafac®
Indications for Use: Provides for the combined use of two previously approved Type A Medicated Articles in the manufacture of Type C medicated feeds.
Date of Approval: July 27, 1999

NADA 141-120 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Clomipramine hydrochloride
Trade Name: Clomicalm ™ Tablets
Indications for Use: To be used apart of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
Date of Approval: December 10, 1998

NADA 141-120 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Clomipramine hydrochloride
Trade Name: CLOMICALM Tablets
Effect of Supplement: This supplement provides for the addition of a 5 mg tablet size.
Date of Approval: November 22, 2006

NADA 141-121 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin, bacitracin methylene disalicylate, roxarsone
Trade Name: BIO-COX® / BMD® / 3-NITRO®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, as an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler, roaster, and replacement (breeder and layer) in chickens not laying eggs.
Date of Approval: December 23, 1999

NADA 141-123 original approval
Sponsor: Merial Ltd.
Generic Name: Omeprazole
Trade Name: GastroGard ™
Indications for Use: For the treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
Date of Approval: March 16, 1999

NADA 141-124 original approval
Sponsor: Alpharma, Inc.
Generic Name: Narasin, Nicarbazin, Bacitracin methylene disalicylate
Trade Name: Maxiban plus BMD
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E acervulina, E. maxima, E. brunetti, and E. mivati; and as an aid in the control or prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
Date of Approval: January 14, 2002

NADA 141-129 original approval
Sponsor: Hoechst Roussel Vet
Generic Name: Lasalocid, bambermycins
Trade Name: Avatec®, Flavomycin®
Indications for Use: For the combined use of two previously approved Type A Medicated Articles in the manufacture of Type C medicated feeds.
Date of Approval: August 6, 1999

NADA 141-135 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin, roxarsone
Trade Name: BIO-COX® / 3-NITRO®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in roaster and replacement (breeder and layer) chickens not laying eggs.
Date of Approval: May 26, 2000

NADA 141-136 original approval
Sponsor: Alpharma, Inc.
Generic Name: Salinomycin sodium, bacitracin methylene disalicylate
Trade Name: Bio-Cox® plus BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, as an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 20, 2000

NADA 141-138 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin, Bacitracin methylene disalicylate, Roxarsone
Trade Name: COBAN®, BMD®, 3-NITRO®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E.  runette, and E. mivati, as an aid in the prevention or control of necrotic enteritis caused or complicated by Clostridium spp. Or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens intended for use as cage layers.
Date of Approval: June 28 2000

NADA 141-139 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin, Roxarson
Trade Name: COBAN®, 3-NITRO
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens intended for use as cage layers.
Date of Approval: June 28 2000

NADA 141-140 original approval
Sponsor: Alpharma, Inc.
Generic Name: Monensin, Bacitracin methylene disalicylate
Trade Name: COBAN®, BMD®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima, and for increased rate of weight gain and for improved feed efficiency in replacement chickens intended for use as cage layers; As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella,
E. acervulina, E. brunetti, E. mivati, and E. maxima, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin in broiler chickens and replacement chickens intended for use as cage layers.
Date of Approval: January 2, 2001

NADA 141-142 original approval
Sponsor: Alpharma, Inc.
Generic Name: Amprolium, Bacitracin methylene disalicylate, Roxarsone
Trade Name: AMPROL®, BMD®, 3-NITRO®
Indications for Use: For development of active immunity to coccidiosis, as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in replacement chickens.
Date of Approval: February 16, 2001

NADA 141-143 original approval
Sponsor: Norbrook Laboratories Limited
Generic Name: Oxytetracycline injection
Trade Name: TETRADURE 300 (Oxytetracycline) Injection (Rx product), OTC product: Oxytetracycline Injrection 300 mg/mL
Indications for Use: Beef and non-lactating dairy cattle, calves, including pre-ruminating (veal) calves: for the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot-rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresi; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococcal and streptococcal organisms sensitive to oxytetracycline. Also, TETRADURE 300 is indicated (prescription use) for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia (Pasteurella) haemolytica. Swine: for the treatment of bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and leptospirosis caused by Leptospira pomona. In sows, oxytetracycline is indicated as an aid in the control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli.
Date of Approval: July 25, 2003

NADA 141-144 original approval
Sponsor: Alpharma, Inc.
Generic Name: Bacitracin methylene disalicylate, fenbendazole
Trade Name: BMD® / SAFE-GUARD®
Indications for Use: Fenbendazole is indicated for the removal of:
Lungworms: adult (Metastrongylus apri, M. pudendotectus)
Gastrointestinal worms: adult and larvae (L3, L4 stages – liver, lung, and intestinal forms) large roundworms (Ascaris suum), adult nodular worms (Oesophagostomum dentatum, O. quadrispinulatum), small stomach worms (Hyostrongylus rubidus), adult and larvae (L2, L3, L4 stages – intestinal mucosal forms) whipworms (Trichuris suis)
Kidneyworms: adult and larvae (Stephanurus dentatus) Bacitracin methylene disalicylate is indicated for:
Increased rate of weight gain and improved feed efficiency in growing and finishing swine
Control of clostridial enteritis in suckling pigs caused by Clostridium perfringens when fed to pregnant sows during the period from 14 days before farrowing through 21 days after farrowing
Control of swine dysentery associated with Treponema hyodysenteriae in growing and finishing swine on premises with a history of swine dysentery but where signs of disease have not yet occurred or following an approved treatment of the disease
Date of Approval: April 7, 2000

NADA 141-146 original approval
Sponsor: Koffolk, Inc.
Generic Name: Nicarbazin, Bacitracin zinc
Trade Name: NICARB® BACIFERM®
Indications for Use: As an aid in preventing outbreaks of cecal (Eimeria tenella) and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis, and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: February 2, 2000

NADA 141-147 original approval
Sponsor: Alpharma, Inc
Generic Name: Decoquinate, chlortetracycline
Trade Name: Deccox® plus Chloromax®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; for the treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: September 29, 2000

NADA 141-147 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: Decoquinate Chlortetracycline
Trade Name: DECCOX CHLORMAX
Effect of Supplement: To revise the Type B and C labeling with the revised decoquinate range of 12.9 to 90.8 g/ton and chlortetracycline range of 500 to 4000 g/ton in the Type C complete feed and decoquinate range of 90.9 to 535.7 g/ton and chlortetracycline range of 4000 to 20,000 g/ton in the Type C supplement feed.
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; for the treatment of bacterial enteritis caused by Escherichia coli and for bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: December 16, 2004

NADA 141-148 original approval
Sponsor: Alpharma, Inc
Generic Name: decoquinate, monensin
Trade Name: DECCOX® RUMENSIN®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii, and for increased feed efficiency in cattle being fed in confinement for slaughter.
Date of Approval: November 16, 2000

NADA 141-148 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: Decoquinate Monensin Sodium
Trade Name: DECCOX® / RUMENSIN®
Effect of Supplement: Provides for the expanded dose range of 12.9 to 90.8 grams per ton of feed for decoquinate when used in combination with monensin sodium, and for revised Blue Bird labels.
Date of Approval: July 30, 2004

NADA 141-149 original approval
Sponsor: Alpharma, Inc
Generic Name: decoquinate, monensin, tylosin
Trade Name: Deccox® Rumensin® Tylan®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis, and E. zuernii, for improved feed efficiency and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces pyogenes in growing-finishing cattle being fed in confinement for slaughter.
Date of Approval: November 16, 2000

NADA 141-150 original approval
Sponsor: Roche Vitamins, Inc.
Generic Name: Lasalocid, virginiamycin
Trade Name: Avatec®, Stafac®
Indications for Use: For the combined use of two previously approved Type A Medicated Articles in the manufacture of Type C medicated feeds.
Date of Approval: August 6, 1999

NADA 141-151 original approval
Sponsor: Pfizer, Inc.
Generic Name: Marbofloxacin
Trade Name: Zeniquin ™
Indications for Use: Zeniquin ™ (marbofloxacin) tablets are indicated for the treatment of infections in dogs associated with bacteria susceptible to marbofloxacin.
Clinical effectiveness was confirmed in skin and soft tissue infections and urinary tract infections (cystitis) associated with bacteria susceptible to marbofloxacin.
Date of Approval: June 26, 1999

NADA 141-151 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Marbofloxacin
Trade Name: Zeniquin ™
Indications for Use: Provides for the use of Zeniquin (marbofloxacin) tablets in cats for the treatment of infections in dogs associated with bacteria susceptible to marbofloxacin.
Date of Approval: August 1, 2001

NADA 141-152 original approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution ™
Indications for Use: Revolution kills adult fleas and prevents flea eggs from hatching for one month and is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and the treatment and control of ear mite (Otodectes cynotis) infestations in dogs and cats. Revolution also is indicated for the treatment and control of sarcoptic mange (Sarcoptes scabiei) in dogs, and the treatment of intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections in cats. Revolution is recommended for use in dogs and cats six weeks of age and older.
Date of Approval: May 26, 1999

NADA 141-152 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution ™
Effect of Supplement: Provides for the additional indication for control of tick infestations in dogs
Date of Approval: August 5, 1999

NADA 141-152 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Selamectin
Trade Name: Revolution ™
Effect of Supplement: Provide additional indication for control of intestinal hookworm (Ancylostoma tubaeforme) and roundworm(Toxocara cati) infections in cats.
Date of Approval: June 13, 2000

NADA 141-153 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bacitracin methylene disalicylate
Trade Name: Clinacox ™, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mitis (mivati) and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. For increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: January 13, 2000

NADA 141-154 original approval
Sponsor: Alpharma, Inc.
Generic Name: Robenidine hydrochloride, Bacitracin methylene disalicylate
Trade Name: Robenz® plus BMD®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E acervulina, E. maxima, E. brunetti, and E. mivati and as an aid in the control or prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin.
Date of Approval: February 11, 2002

NADA 141-155 original approval
Sponsor: Alpharma, Inc.
Generic Name: Robenidine hydrochloride, Bacitracin methylene disalicylate, Roxarsone
Trade Name: Robenz®, BMD®, 3-Nitro®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E acervulina, E. maxima, E. brunetti, and E. mivati and as an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens; .
Date of Approval: July 3, 2000

NADA 141-156 original approval
Sponsor: Alpharma, Inc.
Generic Name: Amprolium, Bacitracin methylene disalicylate
Trade Name: AMPROL®, BMD®
Indications for Use: For the development of active immunity to coccidiosis, and for increased rate of weight gain and improved feed efficiency in replacement chickens.
Date of Approval: February 12, 2001

NADA 141-157 original approval
Sponsor: Alpharma, Inc.
Generic Name: Halofuginone hydrobromide, roxarsone
Trade Name: Stenorol® / 3-Nitro®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati (E. mitis), and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in chickens not laying eggs.
Date of Approval: July 3, 2000

NADA 141-158 original approval
Sponsor: Shering-Plough Animal Health Corporation
Generic Name: Diclazuril Bambermycins
Trade Name: Clinacox ™; Flavomycin®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati (E. mitis). Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. For increased rate weight gain and improved feed efficiency in broiler chickens.
Date of Approval: July 3, 2000

NADA 141-162 original approval
Sponsor: Wellmark International
Generic Name: (S)-Methoprene
Trade Name: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® FLEA CONTROL CAPSULES™
Indications for Use: ZODIAC® FLEATROL™ FLEA CAPS™ and HARTZ® Flea Control Capsules™ are indicated for use in dogs, nine weeks of age and older and 4 pounds body weight or greater, for the prevention and control of flea populations. (S)-Methoprene prevents and controls flea populations by preventing the development of flea eggs and does not kill adult fleas. Concurrent use of insecticides may be necessary for adequate control of adult fleas.
Date of Approval: January 24, 2000

NADA 141-163 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin Oxime Solution
Trade Name: MILBEMITE™ OTIC Solution
Indications for Use: MILBEMITE OTIC Solution is indicated for treatment of ear mite (Otodectes cyanotis) infestations in cats and kittens eight weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.
Date of Approval: February 2, 2000

NADA 141-163 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Milbemycin Oxime Solution
Trade Name: MILBEMITE™ OTIC Solution
Effect of Supplement: This supplement provides target animal safety study data to lower the age limitation of the product from 8 to 4 week old kittens and to allow a repeat treatment if necessary.
Date of Approval: December 13, 2000

NADA 141-164 original approval
Sponsor: Elanco Animal Health
Generic Name: Monensin, Tylosin phosphate
Trade Name: COBAN®, TYLAN®
Indications for Use: As an aid in the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency in broiler chickens.
Date of Approval: July 3, 2000

NADA 141-170 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Narasin, tylosin phosphate
Trade Name: Monteban® plus Tylan®
Indications for Use: For the prevention of coccidiosis caused by Eimeria necatrix, E. tenella, E. acervulina, E. brunetti, E. mivati, and E. maxima, for increased rate of weight gain and improved feed efficiency.
Date of Approval: September 20, 2000

NADA 141-171 original approval
Sponsor: Purina Mills, Inc.
Generic Name: Lasalocid
Trade Name: Bovatec® 68 Purina Sugar Mag Block 1440 BVT Medicated Mineral Block
Indications for Use: For increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).
Date of Approval: August 20, 2002

NADA 141-172 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, Tylosin phosphate
Trade Name: PAYLEAN®, TYLAN®
Indications for Use:  1) For increased weight gain, improved feed efficiency and increased carcass leanness in finishing swine fed a complete ration containing at least 16% crude protein from 150 lb (68kg) to 240 lb (109 kg) body weight, and for prevention and/or control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis. 2) For improved feed efficiency and increased carcass leanness in finishing swine fed a complete ration containing at least 16% crude protein from 150 lb (68kg) to 240 lb (109 kg) body weight, and for prevention and/or control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis.
Date of Approval: February 20, 2001

NADA 141-172 supplemental approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, Tylosin phosphate
Trade Name: PAYLEAN®, TYLAN®
Effect of Supplement: To provide for the use of ractopamine and tylosin single-ingredient Type A medicated articles to make a combination drug type C medicated feed and to add the claim for the prevention of swine dysentery in finishing swine.
Date of Approval: June 19, 2002

NADA 141-172 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride and tylosin phosphate
Trade Name: PAYLEAN and TYLAN
Effect of Supplement: This supplement provides for the combined use of ractopamine hydrochloride and tylosin phosphate in swine in excess of 240 lb and
reduces the maximum dose of ractopamine hydrochloride to 10 ppm (9 g/ton).
Date of Approval: October 20, 2006

NADA 141-174 original approval
Sponsor: Blue Ridge Pharmaceuticals, Inc.
Generic Name: Ivermectin otic suspension
Trade Name: ACAREXX™
Indications for Use: ACAREXX is indicated for the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens four weeks of age or older. Effectiveness against eggs and immature stages has not been proven.
Date of Approval: December 5 , 2000

NADA 141-175 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Nitenpyram
Trade Name: Capstar™
Indications for Use: For the treatment of flea infestations on dogs, puppies, cats and kittens four weeks of age and 2 pounds of body weight or greater.
Date of Approval: October 20, 2000

NADA 141-175 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Nitenpyram
Trade Name: Capstar™
Effect of Supplement: 1. The text in the “Indications” section is changed to include the words “kill adult fleas.” The section will now read: “CAPSTAR® Tablets kill adult fleas and are indicated for the treatment of flea infestations on dogs, puppies, cats and kittens 4 weeks of age and older and 2 pounds of body weight or greater.” This change makes the labeling more consistent with labeling for other approved products that kill adult fleas.
2. There are some minor revisions to clarify the currently approved text in the package insert and the unit dose cartons.
3. The package insert is revised to include reference to the concurrent use of PROGRAM® (lufenuron) Flavor Tabs® (NADA 141-035) to kill adult fleas and prevent flea eggs from hatching. The information supporting approval for this concurrent use is documented in NADA 141-205.
4. The package insert is revised to refer the reader to a veterinarian for information about the concurrent use of SENTINEL® (milbemycin oxime/lufenuron) Flavor Tabs® (NADA 141-084), to kill adult fleas and prevent flea eggs from hatching. SENTINEL® Flavor Tabs® are a prescription product. The information supporting approval for this concurrent use is documented in NADA 141-204.
5. The unit dose cartons are revised to refer to concurrent use with PROGRAM® (lufenuron) Flavor Tabs®. 6. Each unit dose carton will contain an additional “FLEA MANAGEMENT SYSTEMÔ” package insert that provides specific information for using CAPSTAR® Tablets with PROGRAM® (lufenuron) Flavor Tabs®.
Date of Approval: June 11, 2003

NADA 141-176 original approval
Sponsor: BAYER Corporation
Generic Name: Enrofloxacin/Silver Sulfadiazine
Trade Name: Baytril® Otic
Indications for Use: Baytril® Otic is indicated for the treatment of canine otitis externa complicated by acterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.
Date of Approval: September 29, 2000

NADA 141-177 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Gentamicin sulfate, Clotrimazole, Mometasone furoate monohydrate
Trade Name: Mometamax™ Otic Suspension
Indications for Use: Mometamax™ Otic Suspension is indicated for the treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs.
Date of Approval: December 5 , 2000

NADA 141-177 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Gentamicin sulfate, USP; mometasone furoate monohydrate; and clotrimazole, USP suspension
Trade Name: Mometamax™ Otic Suspension
Indications for Use: For the treament of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and certain bacteria (Pseudomonas supp. including P. aeruginosa, coagulase positive staphylococci, Enterococcus faecalis, Proteus mirabilis and beta-hemolytic streptococci).
Date of Approval: January 9, 2003

NADA 141-177 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Gentamicin sulfate, USP; mometasone furoate monohydrate; and clotrimazole, USP suspension
Trade Name: MOMETAMAX
Effect of Supplement: New package size (7.5g bottle) 
Date of Approval: June 1, 2005

NADA 141-178 original approval
Sponsor: IDEXX Pharmaceuticals, Inc.
Generic Name: Nitazoxanide
Trade Name: NAVIGATOR (32% nitazoxanide) Antiprotozoal Oral Paste
Indications for Use: NAVIGATOR (32% nitazoxanide) Antiprotozoal Oral Paste in indicated for the treatment of horses with equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona.
Date of Approval: November 18, 2003

NADA 141-179 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid sodium, Bacitracin methylene disalicylate
Trade Name: AVATEC®, BMD®
Indications for Use: For the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and
E. adenoeides, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: July 11, 2001

NADA 141-180 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Albuterol sulfate
Trade Name: Torpex™
Indications for Use: For the immediate relief of bronchospasm and bronchoconstriction associated with reversible airway obstruction in horses.
Date of Approval: November 16, 2001

NADA 141-181 original approval
Sponsor: Alpharma, Inc.
Generic Name: Lasalocid, Bacitracin zinc
Trade Name: AVATEC, ALBAC
Indications for Use: For the prevention of coccidiosis caused by Eimeria meleagrimitis, E. gallopavonis, and E. adenoeides, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: May 15, 2002

NADA 141-185 original approval
Sponsor: Alpharma, Inc.
Generic Name: decoquinate, chlortetracycline
Trade Name: Deccox® plus Aureomycin®
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii; for the treatment of bacterial enteritis caused by Escherichia coli, and for bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: March 15, 2002

NADA 141-185 supplemental approval
Sponsor: Alpharma Inc.
Generic Name: DECCOX AUREOMYCIN
Trade Name: Decoquinate Chlortetracycline
Indications for Use: For the prevention of coccidiosis caused by Eimeria bovis and E. zuernii for the treatment of bacterial enteritis caused by Escherichia coli and for bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.
Date of Approval: December 16, 2004

NADA 141-186 original approval
Sponsor: IDEXX Pharmaceuticals, Inc.
Generic Name: 1% diclofenac sodium
Trade Name: SURPASS
Indications for Use: SURPASS is indicated for the control of pain and inflammation associated with osteoarthritis (OA) in tarsal, carpal, metacarpophalangeal, metatarsophalangeal, and proximal interphalangeal (hock, knee, fetlock, and pastern) joints in horses.
Date of Approval: May 13, 2004

NADA 141-187 original approval
Sponsor: Ridley Block Operations Inc.
Generic Name: Lasalocid
Trade Name: DBOVATEC 68
Indications for Use: For increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, and dairy and beef replacement heifers).
Date of Approval: December 12, 2003

NADA 141-188 original approval
Sponsor: Bayer Animal Health
Generic Name: Ponazuril
Trade Name: Marquis™
Indications for Use: For the treatment of Equine Protozoal Myeloencephalitis (EPM) caused by Sarcocystis neurona
Date of Approval: July 19, 2001

NADA 141-189 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: Moxidectin
Trade Name: ProHeart® 6 Sustained Release Injectable for Dogs
Indications for Use: For the prevention of heartworm disease caused by Dirofilaria immitis and for treatment of existing larval and adult hookworm (Ancylostoma caninum) infections.
Date of Approval: June 06, 2001

NADA 141-189 supplemental approval
Sponsor: Fort Dodge Animal Health, Div. of American Home Products, Inc.
Generic Name: Moxidectin
Trade Name: ProHeart® 6 Sustained Release Injectable for Dogs
Effect of Supplement: New indication for the treatment of existing larval and adult hookworm (Uncinaria stenocephala) infections.
Date of Approval: June 13, 2002

NADA 141-189 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Moxidectin
Trade Name: PROHEART 6 Sustained Release Injectable for Dogs
Effect of Supplement: This supplement provides for the revision of the animal safety information in the warning, precaution, adverse reactions, and post-approval sections of the product labeling.
Date of Approval: May 23, 2008

NADA 141-190 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: Diclazuril, Bacitracin methylene disalicylate, Roxarsone
Trade Name: Clinacox plus BMD® plus 3-Nitro®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati), and E. maxima. Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima. As an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin or as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin. For increased rate of weight gain, improved feed efficiency and improved pigmentation in broiler chickens.
Date of Approval: December 14, 2001

NADA 141-192 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Zeranol
Trade Name: Ralgro® LA
Indications for Use: For increased rate of weight gain for up to 210 days in pasture cattle (slaughter, stocker, and feeder steers and heifers).
Date of Approval: November 1, 2001

NADA 141-192 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Zeranol
Trade Name: Ralgro® L.A.
Effect of Supplement: This supplement provides for addition to the labeling of the statements “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.” to the warning section and “Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.” immediately following the label indications.
Date of Approval: January 14, 2005

NADA 141-193 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: tepoxalin
Trade Name: ZUBRIN™ Rapidly-Disintegrating Tablets
Indications for Use: ZUBRIN™ (tepoxalin) Tablets are indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: March 31, 2003

NADA 141-194 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bacitracin methylene disalicylate
Trade Name: CLINACOX™, BMD®
Indications for Use: Growing Turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: April 2, 2002

NADA 141-195 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Diclazuril, Bambermycins
Trade Name: CLINACOX™, FLAVOMYCIN®
Indications for Use: Growing Turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for improved feed efficiency in growing turkeys or for the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis, and E. meleagrimitis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
Date of Approval: April 2, 2002

NADA 141-198 original approval
Sponsor: Elanco Animal Health, A division of Eli Lilly and Co.
Generic Name: Tylosin, salinomycin
Trade Name: Tylan® /Bio-Cox®
Indications for Use: For increased rate of weight gain and improved feed efficiency, and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunette, and E. mivati in broiler chickens.
Date of Approval: September 4, 2002

NADA 141-199 original approval
Sponsor: Pfizer, Inc.
Generic Name: Carprofen
Trade Name: RIMADYL® INJECTABLE
Indications for Use: Rimadyl® Injectable is indicated for the relief of
pain and inflammation associated with
osteoarthritis in dogs.
Date of Approval: March 3, 2003

NADA 141-199 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Carprofen
Trade Name: RIMADYL® INJECTABLE
Effect of Supplement: provides for the addition of a once daily administration of 2 mg/lb (4.4 mg/kg) of body weight in addition to a twice daily administration of 1 mg/lb (2.2 mg/kg) by subcutaneous injection.
Date of Approval: March 25, 2003

NADA 141-199 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Carprofen
Trade Name: RIMADYL® INJECTABLE
Effect of Supplement: This supplement to NADA 141-199 provides revisions to 21CFR 522.312 (2) Indications for Use. To add a claim for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs.
Date of Approval: April 2, 2003

NADA 141-200 original approval
Sponsor: DEC INTERNATIONAL, INC
Generic Name: Intravaginal Progesterone Insert
Trade Name: EAZI-Breed™ CIDR® Cattle Insert
Indications for Use: 1. Synchronization of estrus in suckled beef cows, and replacement beef and dairy heifers. 2. Advancement of first postpartum estrus in suckled beef cows. 3. Advancement of first pubertal estrus in replacement beef heifers.
Date of Approval: May 2, 2002

NADA 141-200 supplemental approval
Sponsor: PHARMACIA & UPJOHN COMPANY
Generic Name: Progesterone
Trade Name: EAZI-Breed™ CIDR® Cattle Insert
Indications for Use: For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus
Date of Approval: July 29, 2003

NADA 141-203 original approval
Sponsor: Novartis Animal Health US, Inc
Generic Name: deracoxib
Trade Name: DERAMAXX Chewable Tab
Indications for Use: DERAMAXX™ Chewable Tablets are indicated for the
control of postoperative pain and inflammation associated with orthopedic surgery in dogs > 4 lbs (1.8 kg).
Date of Approval: August 21, 2002

NADA 141-203 supplemental approval
Sponsor: Novartis Animal Health US, Inc
Generic Name: deracoxib
Trade Name: DERAMAXX Chewable Tab
Effect of Supplement: The supplement to NADA 141-203 provides revisions to 21 CFR 520.538. Indications for Use. To add a claim for the control of pain and inflammation associated with osteoarthritis in dogs. Amount: To add a new dose range of 1-2 mg/kg (0.45-0.91 mg/lb).
Date of Approval: February 11, 2003

NADA 141-203 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: deracoxib
Trade Name: DERAMAXX Tablets
Effect of Supplement: This supplement provides for the addition of a 75 mg tablet size.
Date of Approval: June 13, 2007

NADA 141-203 supplemental approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Deracoxib
Trade Name: DERAMAXX Chewable Tablets
Effect of Supplement: This supplement provides for the addition of a 50-mg tablet size.
Date of Approval: May 16, 2008

NADA 141-204 original approval
Sponsor: Novartis Animal Health US
Generic Name: Milbemycin oxime/lufenuron, nitenpyram
Trade Name: Sentinel® Flavor Tabs® , Capstar® Tablets, Flea Management System™
Indications for Use: For use in dogs 4 weeks and older to kill adult fleas and to prevent flea eggs from hatching.
Date of Approval: June 11, 2003

NADA 141-205 original approval
Sponsor: Novartis Animal Health US
Generic Name: Lufenuron, nitenpyram
Trade Name: PROGRAM® Flavor Tabs® and CAPSTAR® Tablets
Indications for Use: For use to kill adult fleas and to prevent flea eggs from hatching.
Date of Approval: June 11, 2003

NADA 141-206 original approval
Sponsor: Schering-Plough Animal Health
Generic Name: Florfenicol
Trade Name: Nuflor® 2.3% Concentrate Solution
Indications for Use: For treatment of swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis Type 2.
Date of Approval: September 4, 2002

NADA 141-207 original approval
Sponsor: Pfizer, Inc.
Generic Name: Danofloxacin mesylate
Trade Name: A 180®
Indications for Use: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia (Pastreurella) haemolytica and Pasteurella multocida.
Date of Approval: September 20, 2002

NADA 141-208 original approval
Sponsor: Bayer Corp.
Generic Name: Imidacloprid, invermectin
Trade Name: Advantage® DUO
Indications for Use: For the prevention of heartworm disease caused by Dirofilaria immitis. Also indicated for the treatment of flea infestation (Ctenocephalides felis).
Date of Approval: September 27, 2002

NADA 141-209 original approval
Sponsor: PHARMACIA & UPJOHN COMPANY
Generic Name: ceftiofur crystalline free acid
Trade Name: NAXCEL XT STERILE SUSPENSION
Indications for Use: NAXCEL XT STERILE SUSPENSION is indicated for treatment of BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida and H. omnus. NAXCEL XT STERILE SUSPENSION is also indicated for the control of respiratory disease in cattle which are at high risk of developing BRD associated with Mannheimia. haemolytica, P. multocida and H. somnus.
Date of Approval: September 5, 2003

NADA 141-209 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur crystalline free acid
Trade Name: EXCEDE Sterile Suspension
Effect of Supplement: 1. To add a new route of administration for injection in the posterior aspect of the ear where it attaches to the head (base of ear).
2. To add a new indication, “For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in lactating dairy cattle.”
3. To establish a 13-day pre-slaughter withdrawal period for cattle.
Date of Approval: June 2, 2006

NADA 141-209 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur crystalline free acid
Trade Name: EXCEDE Sterile Suspension
Effect of Supplement: This supplement provides for a new indication, treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.
Date of Approval: August 15, 2008

NADA 141-210 original approval
Sponsor: RMS Laboratories, Inc.
Generic Name: Triamcinolone acetonide 0.015% topical spray
Trade Name: Genesis™ Topical Spray
Indications for Use: For the control of pruritus associated with allegic dermatitis in dogs.
Date of Approval: November 4 , 2002

NADA 141-211 original approval
Sponsor: Phibro Animal Health
Generic Name: Carbadox, oxytetracycline dihydrate base
Trade Name: Mecadox® 10 / Terramycin® 50, 100, or 200
Indications for Use: For the treatment of bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis susceptible to oxytetracycline, treatment of bacterial pneumonia caused by Pasteurella multocida susceptible to oxytetracycline, and increased rate of weight gain and improved feed efficiency.
Date of Approval: July 21, 2004

NADA 141-213 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: meloxicam
Trade Name: Metacam® Oral Suspension
Indications for Use: Metacam® Oral Suspension is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: April 15, 2003

NADA 141-213 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: meloxicam
Trade Name: Metacam® Oral Suspension
Effect of Supplement: This supplement to NADA 141-213 provides revisions to 21 CFR 520.1350 (1) Amount. To change the format to read “administered initially at 0.09 mg/lb (0.2 mg/kg) body weight only on the first day of treatment. For all treatments after day 1, METACAM Oral Suspension should be administered once daily at a dose of 0.045 mg/lb (0.1 mg/kg).”
Date of Approval: October 28, 2004

NADA 141-214 original approval
Sponsor: Merial Limited
Generic Name: Ivermectin/praziquantel
Trade Name: Zimecterin® Gold Paste
Indications for Use: For treatment and control of the following parasites in horses: Tapeworms: noplocephala perfoliata Large strongyles (adults):
Strongylus vulgaris (also early forms in blood vessels) Strongylus edentatus (also tissue stages) Strongylus equinus Triodontophorus spp. including: Triodontophorus brevicauda Triodontophorus serratus
Craterostomum acuticaudatum Small strongyles: Including those resistant to some benzimidazole class compounds (adults and 4th stage larvae)
Coronocyclus spp. including: Coronocyclus coronatus Coronocyclus labiatus Coronocyclus labratus Cyathostomum spp. including:
Cyathostomum catinatum Cyathostomum pateratum Cylicocyclus spp. including: Cylicocyclus insigne Cylicocyclus leptostomum Cylicocyclus nassatus Cylicocyclus brevicapsulatus Cylicodontophorus spp.
Cylicostephanus spp. including: Cylicostephanus calicatus Cylicostephanus goldi Cylicostephanus longibursatus Cylicostephanus minutus Petrovinema poculatum Pinworms (adults and 4th stage larvae) - Oxyuris equi Ascarids (adults and 3rd and 4th stage larvae) - Parascaris equorum Hairworms (adults) - Trichostrongylus axei Large-mouth stomach worms (adults) - Habronema muscae Bots (oral and gastric stages) – Gasterophilus spp. including G. intestinalis and G. nasalis
Lungworms (adults and 4th stage larvae) - Dictyocaulus arnfieldi
Intestinal threadworms (adults) - Strongyloides westeri Summer sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; dermatitis caused by neck threadworm microfilariae, Onchocerca
Date of Approval: April 17, 2003

NADA 141-214 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin, praziquantel
Trade Name: Zimermectin® Gold Paste
Effect of Supplement: This supplement amends the ZIMECTRIN Gold (ivermectin/praziquantel) Paste labeling to reflect a change in the indications section. Specifically, under the sub-heading Small Strongyles, the labeling has been revised to separate the listing of adult species from the fourth-stage larvae. The label language has also been revised for treatment frequency; removing the eight week intertreatment interval because treatment frequency should be based on a parasite control program designed specifically for each horse. A new precaution statement has also been added.
Date of Approval: July 13, 2004

NADA 141-214 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Ivermectin/praziquantel
Trade Name: ZIMECTERIN Gold Paste
Effect of Supplement: This supplement amends the ZIMECTERIN Gold (ivermectin/praziquantel) Paste labeling to reflect the change in the age of treatment from “5 months of age and older” to “2 months of age and older.”
Date of Approval: October 28, 2005

NADA 141-215 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin/Pra ziquantel Paste
Trade Name: EQUIMAXTM Paste
Indications for Use: Indications: Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism. EQUIMAX™ (ivermectin/praziquantel) Paste is indicated for the treatment and control of the following parasites:
Tapeworms: Anoplocephala perfoliata
Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp.
Small Strongyles including those resistant to some benzimidazole class compounds (adults and fourth-stage larvae): Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp.
Pinworms (adults and fourth-stage larvae): Oxyuris equi
Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum
Hairworms (adults): Trichostrongylus axei
Large-mouth Stomach Worms (adults): Habronema muscae
Bots (oral and gastric stages): Gasterophilus spp.
Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi
Intestinal Threadworms (adults): Strongyloides westeri
Summer sores caused by Habronema and Draschia spp. cutaneous third- stage larvae.
Dermatitis caused by Neck threadworm microfilariae, Onchocerca
Date of Approval: July 11, 2003

NADA 141-215 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin/praziquantel
Trade Name: EQUIMAX
Effect of Supplement: This supplement provides for the use of EQUIMAX Paste in breeding, pregnant or lactating mares without adverse effects on fertility.
Date of Approval: July 30, 2004

NADA 141-215 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: ivermectin/praziquantel
Trade Name: EQUIMAX
Effect of Supplement: This is a regulatory supplement requested by the Division of Surveillance to bring product labeling into compliance with the pioneer product. Therefore, this supplement provides for separation of small strongyle fourth-stage larvae from the small strongyle adults, which are speciated in the indication section of the product labeling. In addition, it revises the Warning statement to read “Do not use in horses intended for human consumption.”
Date of Approval: September 16, 2005

NADA 141-216 original approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name: Moxidectin, praziquantel
Trade Name: Quest® Plus Gel
Indications for Use: For the treatment and control of the following stages of gastrointestinal parasites of horses and ponies six months of age and older and not to be used for food
Date of Approval: May 14, 2003

NADA 141-216 original approval
Sponsor: Fort Dodge Animal Health, Division of Wyeth
Generic Name: Moxidectin, praziquantel
Trade Name: Quest® Plus Gel
Indications for Use: For the treatment and control of the following stages of gastrointestinal parasites of horses and ponies
Date of Approval: March 17, 2004

NADA 141-216 supplemental approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin and praziquantel
Trade Name: QUEST Plus Gel
Effect of Supplement: The supplement provides for the use of QUEST Plus gel for the treatment and control of adult Cylicocyclus radiatus and Petrovinema poculatus based on results from additional dose confirmation studies.
Date of Approval: November 23, 2005

NADA 141-217 original approval
Sponsor: Technology Transfer, Inc.
Generic Name: Zinc Gluconate Neutralized by Arginine
Trade Name: Neutersol® Injectable Solution
Indications for Use: Neutersol® Injectable Solution is indicated for chemical sterilization in 3 to 10 month old male dogs.
Date of Approval: March 17, 2003

NADA 141-218 original approval
Sponsor: Novartis Animal Health US, Inc.
Generic Name: Cyclosporine capsules, USP Modified
Trade Name: ATOPICA
Indications for Use: For the control of atopic dermatitis in dogs weighing at least 4 lbs body weight.
Date of Approval: August 15, 2003

NADA 141-219 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Meloxicam
Trade Name: AMETACAM (meloxicam) 5 mg/mL Solution for Injection
Indications for Use: METACAM (meloxicam) 5 mg/mL Solution for Injection is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: November 12, 2003

NADA 141-219 supplemental approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Meloxicam
Trade Name: METACAM 5 mg/mL Solution for Injection
Effect of Supplement: To add a claim for the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy and castration when administered prior to surgery in cats.
Date of Approval: October 28, 2004

NADA 141-220 original approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: CYDECTIN Injectable Solution for Beef and Nonlactating Dairy Cattle
Indications for Use: CYDECTIN Injectable when administered at the recommended dose level of 0.2 mg/2.2 lb (0.2 mg/kg) body weight is effective in the treatment and control of the following internal and external parasites of cattle:
Date of Approval: May 20, 2005

NADA 141-220 supplemental approval
Sponsor: Fort Dodge Animal Health
Generic Name: Moxidectin
Trade Name: CYDECTIN Injectable Solution for Beef and Nonlactating Dairy Cattle
Effect of Supplement: Addition of six new therapeutic claims:
Trichostrongylus colubriformis – Adult
Cooperia pectinata – Adult
Cooperia spatulata – Adult
Nematodirus helvetianus – Adult
Ostertagia ostertagi – L4
Trichostrongylus axei – L4
Date of Approval: January 10, 2006

NADA 141-221 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride
Trade Name: OPTAFLEXX™ 45
Indications for Use: 1) (8.2 – 24.6 g/ton) - For increased rate of weight gain, and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
2) ( 9.8 – 24.6 g/ton) - For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
Date of Approval: June 13, 2003

NADA 141-222 original approval
Sponsor: Intervet, Inc.
Generic Name: Altrenogest
Trade Name: MATRIX
Indications for Use: For synchronization of estrus in sexually mature gilts that have had at least one estrous cycle.
Date of Approval: September 30, 2003

NADA 141-223 original approval
Sponsor: Alpharma, Inc.
Generic Name: Diclazuril, roxarsone
Trade Name: Clinacox ™ / 3-Nitro®
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunette, E. mitis (mivati), and E. maxima. Also, for increased rate of weight gain, improved feed efficiency, and improved pigmentation.
Date of Approval: January 27, 2004

NADA 141-224 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, monensin sodium, tylosin phosphate
Trade Name: Optaflexx ™ / Rumensin ® / Tylan ®
Indications for Use: Increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: January 27, 2004

NADA 141-224 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride, monensin USP, and tylosin phosphate
Trade Name: OPTAFLEXX plus RUMENSIN plus TYLAN
Effect of Supplement: This supplement provides for revised dosing for the combined use of ractopamine hydrochloride, monensin USP, and tylosin phosphate for cattle fed in confinement for slaughter, based on the December 1, 2006, supplemental approval for RUMENSIN (under NADA 095-735), which provided for an increase in the upper dosage limit in cattle being fed in confinement for slaughter. This supplement also updates the name of one of tylosin’s targeted bacteria to Arcanobacterium (Actinomyces) pyogenes, based on the November 7, 2006, supplemental approval for TYLAN (under NADA 012-491).
Date of Approval: October 12, 2007

NADA 141-225 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, monensin sodium
Trade Name: Optaflexx ™ / Rumensin ®
Indications for Use: Increased rate of weight gain, improved feed efficiency, increased carcass leanness, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: January 27, 2004

NADA 141-225 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride and monensin USP
Trade Name: OPTAFLEXX plus RUMENSIN
Effect of Supplement: This supplement provides for revised dosing for the combined use of ractopamine hydrochloride and monensin USP for cattle fed in confinement for slaughter, based on the December 1, 2006, supplemental approval for RUMENSIN (under NADA 095-735), which provided for an increase in the upper dosage limit in cattle being fed in confinement for slaughter.
Date of Approval: October 30, 2007

NADA 141-226 original approval
Sponsor: Phibro Animal Health
Generic Name: Semduramicin sodium Virginiamycin Roxarsone
Trade Name: AVIAX STAFAC ROXARSONE
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, E. mivati/E. mitis, for the prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation in broiler chickens.
Date of Approval: April 6, 2005

NADA 141-227 original approval
Sponsor: Merial Ltd.
Generic Name: Omeprazole
Trade Name: UlcerGard ™
Indications for Use: For the prevention of gastric ulcers.
Date of Approval: February 18, 2004

NADA 141-228 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: N-butylscopolammonium bromide
Trade Name: Buscopan™ Injectable Solution
Indications for Use: BUSCOPAN Injectable Solution is indicated for the control of abdominal pain (colic) associated with spasmodic colic, flatulent colic, and simple impactions in horses.
Date of Approval: May 03, 2004

NADA 141-229 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Romifidine hydrochloride
Trade Name: Sedivet® 1% Injection
Indications for Use: For use as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedure, and minor surgical procedures. Also used as a preanesthetic prior to the induction of general anesthesia.
Date of Approval: June 3, 2004

NADA 141-230 original approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: Previcox™
Indications for Use: For the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: July 21, 2004

NADA 141-230 supplemental approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: PREVICOX
Effect of Supplement: This supplement provides for the addition of a new indication for the control of postoperative pain and inflammation associated with soft-tissue surgery in dogs.
Date of Approval: December 18, 2007

NADA 141-232 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Cefpodoxime proxetil
Trade Name: Simplicef™
Indications for Use: For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus intermedius, Staphylococcus aureus, Streptococcus canis (group G, ß hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.
Date of Approval: July 22, 2004

NADA 141-233 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, monensin sodium, tylosin phosphate, melengestrol acetate
Trade Name: Optaflexx™ / Rumensin® / Tylan® / MGA®
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: July 2, 2004

NADA 141-233 supplemental approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride, monensin USP, tylosin phosphate and melengestrol acetate
Trade Name: OPTAFLEXX plus RUMENSIN plus TYLAN plus MGA
Effect of Supplement: This supplement provides for revised dosing for the combined use of ractopamine hydrochloride, monensin USP, tylosin phosphate and melengestrol acetate for heifers fed in confinement for slaughter, based on the December 1, 2006, supplemental approval for RUMENSIN (under NADA 095-735), which provided for an increase in the upper dosage limit in cattle being fed in confinement for slaughter. This supplement also updates the name of one of tylosin’s targeted bacteria to Arcanobacterium (Actinomyces) pyogenes, based on the November 7, 2006, supplemental approval for TYLAN (under NADA 012-491). In addition, this supplement increases the monensin tolerance in cattle liver from 0.05 to 0.10 ppm.
Date of Approval: September 11, 2007

NADA 141-234 original approval
Sponsor: Elanco Animal Health A Division of Eli Lilly & Co.
Generic Name: Ractopamine hydrochloride, monensin sodium, melengestrol acetate
Trade Name: Optaflexx™ / Rumensin® / MGA®
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 28 to 42 days on feed.
Date of Approval: July 2, 2004

NADA 141-235 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur crystalline free acid
Trade Name: Excede™ For Swine
Indications for Use: For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
Date of Approval: June 18, 2004

NADA 141-236 original approval
Sponsor: Intervet, Inc.
Generic Name: Porcine insulin zinc
Trade Name: Vetsulin™
Indications for Use: For the reduction of hyperglycemia and hyperglycemia associated clinical signs with diabetes mellitus.
Date of Approval: April 1, 2004

NADA 141-236 supplemental approval
Sponsor: Intervet Inc.
Generic Name: Porcine insulin zinc suspension
Trade Name: VETSULIN
Effect of Supplement: This supplement provides for a new starting dose in dogs and for the use of VETSULIN in cats.
Date of Approval: March 24, 2008

NADA 141-238 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: SPECTRAMAST LC Sterile Suspension
Indications for Use: SPECTRAMAST LC Sterile Suspension (ceftiofur hydrochloride) is indicated for the treatment of clinical mastitis in lactating dairy cattle associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. Cows with systemic clinical signs caused by mastitis should receive other appropriate therapy under the direction of a licensed veterinarian.
Date of Approval: February 9, 2005

NADA 141-238 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: SPECTRAMAST LC Sterile Suspension
Effect of Supplement: To establish a 2-day pre-slaughter withdrawal period for cattle
Date of Approval: June 2, 2006

NADA 141-239 original approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: SPECTRAMAST DC Sterile Suspension
Indications for Use: SPECTRAMAST DC Ceftiofur Hydrochloride Sterile Suspension is indicated for the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
Date of Approval: March 15, 2005

NADA 141-239 supplemental approval
Sponsor: Pharmacia & Upjohn Co.
Generic Name: Ceftiofur hydrochloride
Trade Name: SPECTRAMAST DC Sterile Suspension
Effect of Supplement: To establish a 16-day pre-slaughter withdrawal period for cattle
Date of Approval: June 2, 2006

NADA 141-240 original approval
Sponsor: Animal Health Pharmaceuticals, LLC
Generic Name: Sulfadiazine and pyrimethamine
Trade Name: REBALANCE Antiprotozoal Oral Suspension
Indications for Use: REBALANCE Antiprotozoal Oral Suspension is indicated for the treatment of horses with equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona
Date of Approval: November 5, 2004

NADA 141-241
Sponsor: Merial Ltd.
Generic Name: Ivermectin
Trade Name: Zimecterin-EZ™
Indications for Use: For treatment and control of the following parasites in horses: Large strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda, and T. serratus and
Craterostomum acuticaudatum; Small strongyles: (adults, including those resistant to some benzimidazole class compounds) - Coronocyclus spp. including: C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including: C. catinatum, C. pateratum, Cylicocyclus spp. including: C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp. including: C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles – Fourth-stage larvae; Pinworms (adults and fourth-stage larvae) - Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae) - Parascaris equorum; Hairworms (adults) - Trichostrongylus axei; Large-mouth Stomach Worms (adults) - Habronema muscae; Bots (oral and gastric stages) - Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae) - Dictyocaulus arnfieldi; Intestinal Threadworms (adults) - Strongyloides westeri; Summer sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.
Date of Approval: December 16, 2004

NADA 141-244 original approval
Sponsor: Pfizer Inc.
Generic Name: Tulathromycin
Trade Name: DRAXXIN Injectable Solution
Indications for Use: Cattle: DRAXXIN Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni (Haemophilus somnus), and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni (Haemophilus somnus).
Swine: DRAXXIN Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, and Haemophilus parasuis.
Date of Approval: May 24, 2005

NADA 141-244
Sponsor: Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name: Draxxin®
Effect of Supplement: This application provides Mycoplasma bovis to the list of target pathogens for bovine respiratory disease (BRD) treatment indication. This approval qualifies for THREE years of marketing exclusivity.
Date of Approval: August 18, 2006

NADA 141-244 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name: DRAXXIN Injectable Solution
Effect of Supplement: This supplement provides for the addition of Mycoplasma bovis to the list of target pathogens for the BRD control “at high risk” indication.
Date of Approval: September 26, 2007

NADA 141-244 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name: DRAXXIN Injectable Solution
Effect of Supplement: This supplement provides for 1) the addition of a new indication, for the treatment of IBK associated with Moraxella bovis in cattle, and 2) the addition of Mycoplasma hyopneumoniae to the list of pathogens for the SRD indication.
Date of Approval: December 28, 2007

NADA 141-244 supplemental approval
Sponsor: Pfizer, Inc.
Generic Name: Tulathromycin
Trade Name: DRAXXIN Injectable Solution
Effect of Supplement: This supplement provides for a new indication, for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef and non-lactating dairy cattle.
Date of Approval: August 28, 2008

NADA 141-245 original approval
Sponsor: Phoenix Scientific, Inc.
Generic Name: embutramide/chloroquine phosphate/lidocaine
Trade Name: TRIBUTAME* Euthanasia Solution
Indications for Use: TRIBUTAME Euthanasia Solution is indicated for euthanasia in dogs only. * During this product’s development, the proposed trade name was EMBUTANE. This trade name was changed to TRIBUTAME late in the development process. Therefore, most study titles refer to the product as EMBUTANE. However, the reader should be aware that the two trade names refer to the identical product and the word EMBUTANE has been changed to TRIBUTAME wherever possible. 
Date of Approval: May 20, 2005

NADA 141-246 original approval
Sponsor: Schering-Plough Animal Health Corporation
Generic Name: Florfenicol
Trade Name: AQUAFLOR Type A Medicated Article (florfenicol), An Antibiotic
Indications for Use: For the control of mortality in catfish due to enteric septicemia of catfish associated with Edwardsiella ictaluri.
Date of Approval: October 24, 2005

NADA 141-246 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: AQUAFLOR
Effect of Supplement: This supplement provides for the addition of the indication for the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.
Date of Approval: March 19, 2007

NADA 141-246 supplemental approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: AQUAFLOR
Effect of Supplement: This supplement provides for the addition of an indication for the control of mortality in freshwater-reared salmonids due to furunculosis associated with Aeromonas salmonicida.
Date of Approval: October 26, 2007

NADA 141-247 original approval
Sponsor: Fort Dodge Animal Health Division of Wyeth
Generic Name: Moxidectin
Trade Name: CYDECTIN (moxidectin) Oral Drench for Sheep
Indications for Use: CYDECTIN Oral Drench for Sheep, when administered at the recommended dose of 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight (BW), is effective in the treatment and control of the adult and larval (L4) stages of the following internal parasites of sheep:
Haemonchus contortus - Adult and L4 larvae
Teladorsagia circumcincta – Adult and L4 larvae
Teladorsagia trifurcata - Adult and L4 larvae
Trichostrongylus axei - Adult and L4 larvae
Trichostrongylus colubriformis - Adult and L4 larvae
Trichostrongylus vitrinus – Adult and L4 larvae
Cooperia curticei - Adult and L4 larvae
Cooperia oncophora – Adult and L4 larvae
Oesophagostomum columbianum - Adult and L4 larvae
Oesophagostomum venulosum – Adult and L4 larvae
Nematodirus battus - Adult and L4 larvae
Nematodirus filicollis - Adults and L4 larvae
Nematodirus spathiger - Adults and L4 larvae
Date of Approval: November 30, 2005

NADA 141-250 original approval
Sponsor: Alpharma Inc.
Generic Name: Chlortetracycline plus lasalocid sodium
Trade Name: 1) AUREOMYCIN 50, AUREOMYCIN 70, AUREOMYCIN 90 or AUREOMYCIN 100 plus 2) BOVATEC-68, BOVATEC-91, or BOVATEC-20 Liquid
Indications for Use: Indicated for the following numbered indications of combinations of chlortetracycline and lasalocid sodium: 1 and 5, 1 and 6, 1 and 7, 1 and 8, 2 and 7 (with the exception of dairy replacement heifers), 3 and 5, 3 and 6, 3 and 7 (with the exception of dairy replacement heifers), 3 and 8 (with the exception of dairy cattle), 4 and 5, 4 and 6, 4 and 7 (with the exception of dairy replacement heifers), 4 and 8 (with the exception of dairy cattle).
Chlortetracycline
1) 500 to 4,000 g/ton hand feed continuously for not more than 5 days to provide 10 mg/lb per day – for the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline in calves, beef, and non-lactating dairy cattle.
2) 0.5 mg/lb bodyweight daily – for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in beef cattle over 700 pounds.
3) 350 mg per head daily – for control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline in beef cattle under 700 pounds.
4) 350 mg per head daily – for control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline in beef cattle.
Lasalocid sodium
5) 10 to 30 g/ton to provide 100 to 360 mg lasalocid per head per day – for improved feed efficiency in cattle fed in confinement for slaughter.
6) 25 to 30 g/ton to provide 250 to 360 mg lasalocid per head per day – for improved feed efficiency and rate of weight gain in cattle fed in confinement for slaughter.
7) 30 to 600 g/ton to provide 60 to 300 mg/head/day in at least one pound of feed – for increased rate of weight gain in pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers).
8) 30 to 181.8 g/ton to provide 1 mg/2.2 lb bodyweight per day – for the control of coccidiosis caused by Eimeria bovis and Eimeria zuernii in cattle weighing up to 800 pounds with a maximum of 360 mg of lasalocid per head per day.
Date of Approval: March 31, 2006

NADA 141-253 original approval
Sponsor: Merial Ltd.
Generic Name: Firocoxib
Trade Name: EQUIOXX Oral Paste
Indications for Use: EQUIOXX Oral Paste is administered for up to 14 days for the control of pain and inflammation associated with osteoarthritis in horses.
Date of Approval: December 30, 2005

NADA 141-251 original approval
Sponsor: Bayer HealthCare LLC
Generic Name: imidacloprid + moxidectin
Trade Name: ADVANTAGE MULTI for Dogs
Indications for Use: ADVANTAGE MULTI for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. ADVANTAGE MULTI for Dogs kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). ADVANTAGE MULTI for Dogs is also indicated for the treatment and control of the following intestinal parasites:
Date of Approval: December 20, 2006

NADA 141-254 original approval
Sponsor: Bayer HealthCare LLC
Generic Name: imidacloprid + moxidectin
Trade Name: ADVANTAGE MULTI for Cats
Indications for Use: ADVANTAGE MULTI for Cats is indicated for the prevention of heartworm disease caused by Dirofilaria immitis. ADVANTAGE MULTI for Cats kills adult fleas (Ctenocephalides felis) and is indicated for the treatment of flea infestations. ADVANTAGE MULTI for Cats is also indicated for the treatment and control of ear mite (Otodectes cynotis) infestations and the following intestinal parasites:
Date of Approval: January 19, 2007

NADA 141-255 original approval
Sponsor: Eka Chemicals, Inc.
Generic Name: Hydrogen peroxide Liquid solution
Trade Name: 35% PEROX-AID
Indications for Use: For the control of mortality in freshwater-reared finfish eggs due to saprolegniasis. For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacteriurn branchiophilum. And for the control of mortality in freshwater-reared coolwater finfish and channel catfish due to external colurnnaris disease associated with Flavobacterium columnare (Flexibacler columnaris)."
Date of Approval: January 11, 2007

NADA 141-255 original approval
Sponsor: Eka Chemicals, Inc.
Generic Name: Hydrogen peroxide
Trade Name: 35% PEROX-AID
Indications for Use: For the control of mortality in freshwater-reared finfish eggs due to saprolegniasis, for the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum, and for the control of mortality in freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with Flavobacterium columnare (Flexibacter columnaris)
Date of Approval: January 11, 2007

NADA 141-257 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin, pyrantel pamoate, praziquantel
Trade Name: IVERHART MAX Chewable Tablets
Indications for Use: For use in dogs to prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae (Dirofilaria immitis) for a month (30 days) after infection and for the treatment and control of roundworms (Toxocara canis, Toxascaris leonina), hookworms (Ancylostoma caninum, Uncinaria stenocephala, Ancylostoma braziliense) and tapeworms (Dipylidium caninum, Taenia pisiformis).
Date of Approval: October 13, 2006

NADA 141-257 supplemental approval
Sponsor: Virbac AH, Inc.
Generic Name: Ivermectin, pyrantel pamoate, praziquantel
Trade Name: IVERHEART MAX Chewable Tablets
Effect of Supplement: This supplement provides for removal of the following statement from the Precautions section of the package insert: “The effective use of this drug for the treatment and control of tapeworms has not been evaluated in dogs less than 15 pounds.”
Date of Approval: February 15, 2007

NADA 141-258 original approval
Sponsor:
Generic Name: Zilpaterol hydrochloride
Trade Name: Zilmax®
Indications for Use: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 20 to 40 days on feed.
Date of Approval: August 10, 2006

NADA 141-259 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: AQUAFLOR-CA1
Indications for Use: For the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare.
Date of Approval: April 13, 2007

NADA 141-260 original approval
Sponsor: Pfizer, Inc.
Generic Name: Dirlotapide
Trade Name: SLENTROL
Indications for Use: For the management of obesity in dogs
Date of Approval: December 12, 2006

NADA 141-261 original approval
Sponsor: Virbac AH, Inc.
Generic Name: Pyrantel pamoate /Praziquantel
Trade Name: WORMXPLUS* Flavored Chewables VIRBANTEL Flavored Chewables
Indications for Use: For the treatment and control of roundworms (Toxocara canis, Toxascaris leonina); hookworms (Ancylostoma caninum, Ancylostoma braziliense, Uncinaria stenocephala); and tapeworms (Dipylidium caninum, Taenia pisiformis) in dogs and puppies.
Date of Approval: March 13, 2007

NADA 141-262 original approval
Sponsor: Pfizer, Inc.
Generic Name: Maropitant citrate
Trade Name: CERENIA Tablets
Indications for Use: For the prevention of acute vomiting in dogs. For the prevention of vomiting due to motion sickness in dogs
Date of Approval: January 29, 2007

NADA 141-263 original approval
Sponsor: Pfizer, Inc.
Generic Name: Maropitant citrate
Trade Name: CERENIA Injectable Solution
Indications for Use: For the prevention and treatment of acute vomiting in dogs.
Date of Approval: January 29, 2007

NADA 141-264 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol
Trade Name: NUFLOR (florfenicol), An Antibiotic
Indications for Use: For the control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Streptococcus suis, and Bordetella bronchiseptica in groups of swine in buildings experiencing an outbreak of SRD.
Date of Approval: November 3, 2006

NADA 141-265 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Florfenicol (with 2-pyrrolidone and triacetin)
Trade Name: NUFLOR GOLD Injectable Soltuion
Indications for Use: NUFLOR GOLD Injectable Solution is indicated for treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.
Date of Approval: March 21, 2008

NADA 141-267 original approval
Sponsor: Orion Corporation
Generic Name: dexmedetomidine hydrochloride
Trade Name: DEXDOMITOR
Indications for Use: DEXDOMITOR is indicated for use as a sedative and analgesic in dogs to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. DEXDOMITOR is also indicated for use as a preanesthetic to general anesthesia
Date of Approval: December 1, 2006

NADA 141-267 supplemental approval
Sponsor: Orion Corp.
Generic Name: dexmedetomidine hydrochloride
Trade Name: DEXDOMITOR
Effect of Supplement: The effect of the supplement is to add an indication for its use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures in cats.
Date of Approval: September 7, 2007

NADA 141-268 original approval
Sponsor: Schering-Plough Animal Health Corp.
Generic Name: Diclazuril
Trade Name: PROTAZIL Antiprotozoal Pellets
Indications for Use: PROTAZIL Antiprotozoal Pellets are indicated for the treatment of equine protozoal myeloencephalitis (EPM) caused by Sarcocystis neurona in horses.
Date of Approval: March 29, 2007

NADA 141-269 original approval
Sponsor: Intervet Inc.
Generic Name: Trenbolone Acetate and Estradiol
Trade Name: REVALOR-XS
Indications for Use: A slow-release delivery system which increases rate of weight gain and improves feed efficiency for up to 200 days in steers fed in confinement for slaughter.
Date of Approval: January 19, 2007

NADA 141-272 original approval
Sponsor: Elanco Animal Health, A Division of Eli Lilly & Co.
Generic Name: fluoxetine hydrochloride
Trade Name: RECONCILE
Indications for Use: RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan.
Date of Approval: January 19, 2007

NADA 141-273 original approval
Sponsor: Boehringer Ingelheim Vetmedica, Inc.
Generic Name: Pimobendan
Trade Name: VETMEDIN
Indications for Use: VETMEDIN (pimobendan) is indicated for the management of the signs of mild, moderate, or severe (modified NYHA Class II^a, III^b, or IV^c) congestive heart failure in dogs due to atrioventricular valvular insufficiency (AVVI) or dilated cardiomyopathy (DCM). VETMEDIN is indicated for use with concurrent therapy for congestive heart failure (e.g., furosemide, etc.) as appropriate on a case-by-case basis.
^a A dog with modified New York Heart Association (NYHA) Class II heart failure has fatigue, shortness of breath, coughing, etc. apparent when ordinary exercise is exceeded.
^b A dog with modified NYHA Class III heart failure is comfortable at rest, but exercise capacity is minimal.
^c A dog with modified NYHA Class IV heart failure has no capacity for exercise and disabling clinical signs are present even at rest.
Date of Approval: April 30, 2007

NADA 141-274 original approval
Sponsor: Fort Dodge Animal Health
Generic Name: etodolac
Trade Name: ETOGESIC Injectable
Indications for Use: ETOGESIC Injectable is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Date of Approval: September 7, 2007

NADA 141-275 original approval
Sponsor: Bayer HealthCare LLC
Generic Name: emodepside / praziquantel
Trade Name: PROFENDER Topical Solution
Indications for Use: PROFENDER Topical Solution is indicated for the treatment and control of hookworm infections caused by Ancylostoma tubaeforme (adults, immature adults, and fourth stage larvae), roundworm infections caused by Toxocara cati (adults and fourth stage larvae), and tapeworm infections caused by Dipylidium caninum (adults) and Taenia taeniaeformis (adults) in cats.
Date of Approval: June 29, 2007

NADA 141-276 original approval
Sponsor: Intervet Inc.
Generic Name: Zilpaterol hydrochloride, monensin USP, and tylosin phosphate
Trade Name: ZILMAX plus RUMENSIN plus TYLAN
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii and reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes in cattle fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: January 10, 2008

NADA 141-277 original approval
Sponsor: Elanco Animal Health
Generic Name: Spinosad
Trade Name: COMFORTIS
Indications for Use: Kill fleas and are indicated for the prevention and treatment of flea infestations (Ctenocephalides felis) on dogs for one month.
Date of Approval: September 25, 2007

NADA 141-278 original approval
Sponsor: Intervet Inc.
Generic Name: Zilpaterol hydrochloride and monensin USP
Trade Name: ZILMAX plus RUMENSIN
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, and prevention and control of coccidiosis due to Eimeria bovis and E. zuernii in cattle fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: February 15, 2008

NADA 141-280 original approval
Sponsor: Intervet Inc.
Generic Name: Zilpaterol hydrochloride, monensin USP, tylosin phosphate, and melengestrol acetate
Trade Name: ZILMAX plus RUMENSIN plus TYLAN plus MGA
Indications for Use: For increased rate of weight gain, increased carcass leanness, improved feed efficiency, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 20 to 40 days on feed.  
Date of Approval: February 29, 2008

NADA 141-281 original approval
Sponsor: Phibro Animal Health
Generic Name: Semduramicin
Trade Name: AVIAX II
Indications for Use: For the prevention of coccidiosis caused by Eimeria tenella, E. acervulina, E. maxima, E. brunetti, E. necatrix, and E. mitis
Date of Approval: December 7, 2007

NADA 141-282 original approval
Sponsor: Intervet Inc.
Generic Name: Zilpaterol hydrochloride, monensin USP, and melengestrol acetate
Trade Name: ZILMAX plus RUMENSIN plus MGA
Indications for Use: For increased rate of weight gain, improved feed efficiency, increased carcass leanness, prevention and control of coccidiosis due to Eimeria bovis and E. zuernii, and suppression of estrus (heat) in heifers fed in confinement for slaughter for the last 20 to 40 days on feed.
Date of Approval: February 22, 2008

NADA 141-285 original approval
Sponsor: Pfizer, Inc.
Generic Name: Cefovecin sodium
Trade Name: CONVENIA
Indications for Use: For the treatment of skin infections (wounds and abscesses) in cats caused by susceptible strains of Pasteurella multocida.
Date of Approval: April 25, 2008

NADA 141-286 original approval
Sponsor: Intervet Inc.
Generic Name: Fenbendazole/ivermectin/praziquantel
Trade Name: PANACUR Plus Soft Chews
Indications for Use: For the treatment and control of adult Toxocara canis (roundworm), Ancylostoma caninum (hookworm), Trichuris vulpis (whipworm), and Dipylidium caninum (tapeworm), and for the prevention of heartworm disease caused by Dirofilaria immitis in adult dogs.
Date of Approval: May 9, 2008

NADA 141-290 original approval
Sponsor: Elanco Animal Health
Generic Name: Ractopamine hydrochloride
Trade Name: TOPMAX 9
Indications for Use: For increased rate of weight gain and improved feed efficiency in finishing tom turkeys fed for the last 14 days prior to slaughter.  For increased rate of weight gain and improved feed efficiency in finishing hen turkeys fed for the last 7 to 14 days prior to slaughter.
Date of Approval: November 12, 2008

NADA 141-294 original approval
Sponsor: GTC Biotherapeutics, Inc.
Generic Name: Bc6 rDNA construct in GTC 155-92 Goats
Trade Name: Bc6 rDNA construct in GTC 155-92 Goats
Indications for Use: Expression of the human gene for antithrombin (which is intended for the treatment of humans) in the mammary gland
Date of Approval: February 6, 2009

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