[Federal Register: February 23, 2007 (Volume 72, Number 36)]
[Notices]
[Page 8184-8189]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23fe07-65]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004P-0262]
Withdrawal of Approval of 128 Suitability Petitions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 128 suitability petitions. This action is being taken in accordance
with the Pediatric Research Equity Act of 2003 (PREA). Prior to PREA's
enactment, FDA had approved these suitability petitions to permit
abbreviated new drug applications (ANDAs) to be submitted for drugs
that had a different active ingredient, dosage form, or route of
administration than their reference listed drugs (RLDs). However, these
approval decisions are being withdrawn because ANDAs were never
submitted and PREA requires that all applications submitted on or after
April 1, 1999, for a new active ingredient, new indication, new dosage
form, new dosing regimen, or new route of administration contain an
assessment of the safety and effectiveness of the drug for the claimed
indications in relevant pediatric subpopulations unless the requirement
is waived or deferred. This action is being taken without prejudice.
Any of the suitability petitions may be resubmitted for action by the
agency in accordance with current law.
DATES: This notice is effective March 26, 2007.
FOR FURTHER INFORMATION CONTACT: Cecelia M. Parise, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-5845.
SUPPLEMENTARY INFORMATION: PREA (Public Law 108-155) was enacted on
December 3, 2003. Among other things, section 2 of PREA requires that
all drug applications submitted on or after April 1, 1999, for a new
active ingredient, new indication, new dosage form, new dosing regimen,
or new route of administration contain an assessment of the safety and
effectiveness of the drug for the claimed indications in relevant
pediatric subpopulations unless the requirement is waived or deferred.
As a result, FDA is withdrawing its approval for 128 suitability
petitions for which ANDAS were never submitted. The approval decisions,
made prior to the enactment of PREA, would have permitted ANDAs to be
submitted for certain drugs that have a different active ingredient,
dosage form, or route of administration than their RLDs. No ANDAs were
submitted for these drugs pursuant to these suitability petitions prior
to April 1, 1999, and any such application submitted on or after April
1, 1999, would be required to contain the safety and effectiveness
assessments required by PREA, unless waived or deferred. According to
Sec. 314.93(e)(1)(i) (21 CFR 314.93(e)(1)(i)), a suitability petition
may not be approved if investigations must be conducted to show the
safety and effectiveness of the drug product. In addition, according to
Sec. 314.93(f), FDA may withdraw approval of a suitability petition if
it receives information demonstrating that the petition no longer
satisfies the conditions of Sec. 314.93(e). Under PREA, safety and
effectiveness investigations in pediatric subpopulations would be
required for the drug products proposed by these suitability petitions,
unless the requirement is waived or deferred. Therefore, these
suitability petitions no longer satisfy the regulatory requirements for
approval. Pursuant to Sec. 314.93(f), FDA is withdrawing approval of
the 128 suitability petitions listed in the following table:
------------------------------------------------------------------------
Petition
No. Drug Petitioner
------------------------------------------------------------------------
82N-0032/ Chlorzoxazone 500 milligrams (mg) Mikart, Inc.
CP6
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84N-0116/ Disopyramide Phosphate 200 mg or Biocraft Laboratories,
CP1 300 mg Inc.
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84P-0228/ Acetaminophen 500 mg, McNeil Pharmaceutical
CP1 Codeine Phosphate 30 mg or 60 mg
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85P-0067/ Methyltestosterone 25 mg Star Pharmaceuticals
CP1
------------------------------------------------------------------------
85P-0074/ Hydralazine Hydrochloride 25 mg/5 Roxane Laboratories,
CP1 milliliters (mL) Inc.
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85P-0081/ Flurazepam Hydrochloride 30 mg/mL Do.
CP1
------------------------------------------------------------------------
85P-0084/ Vincristine Sulfate 2 mg Bristol Laboratories
CP1
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[[Page 8185]]
85P-0091/ Flurazepam Hydrochloride 15 mg/5 mL Roxane Laboratories,
CP1 Inc.
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85P-0095/ Brompheniramine Maleate 12 mg, UAD Laboratories, Inc.
CP1 Pseudoephedrine Hydrochloride 120
mg
------------------------------------------------------------------------
85P-0129/ Propranolol Hydrochloride 160 mg Verex Laboratories,
CP1 Inc.
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85P-0140/ Dexbrompheniramine Maleate 6 mg, Central
CP1 Pseudoephedrine Hydrochloride 120 Pharmaceuticals, Inc.
mg
------------------------------------------------------------------------
85P-0140/ Dexbrompheniramine Maleate 6 mg, Do.
CP2 Pseudoephedrine Sulfate 120 mg
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85P-0147/ Ketoconazole 20 mg/mL Janssen Pharmaceutica
CP1
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85P-0197/ Propranolol Hydrochloride 80 mg, Forest Laboratories
CP1 120 mg, 160 mg
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85P-0215/ Disulfiram 500 mg/30 mL Paddock Laboratories
CP1
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85P-0238/ Dexbrompheniramine Maleate 6 mg, Bock Pharmacal Co.
CP2 Phenylpropanolamine Hydrochloride
75 mg
------------------------------------------------------------------------
85P-0269/ Codeine Phosphate 10 mg/5 mL, Do.
CP1 Dexbrompheniramine Maleate 1 mg/5
mL,
Phenylpropanolamine Hydrochloride
12.5 mg/5 mL
------------------------------------------------------------------------
85P-0423/ Benztropine Mesylate 0.5 mg/5 mL RIM Consulting Corp.
CP1
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85P-0492/ Azatadine Maleate 1 mg, Smith, Kline & French
CP1 Phenylpropanolamine Hydrochloride Laboratories
75 mg
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85P-0499/ Diazepam 2 mg/5 mL Carolina Medical
CP1 Products Co.
------------------------------------------------------------------------
85P-0510/ Spironolactone 25 mg/5 mL Do.
CP1
------------------------------------------------------------------------
85P-0515/ Lorazepam 0.5 mg, 1 mg, or 2 mg Wyeth Laboratories,
CP1 Inc.
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85P-0516/ Oxazepam 15 mg or 30 mg Do.
CP1
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85P-0543/ Acetaminophen 300 mg, Softan, Inc.
CP1 Codeine Phosphate 30 mg
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85P-0543/ Acetaminophen 500 mg, Do.
CP2 Codeine Phosphate 7.5 or 15 mg
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85P-0543/ Acetaminophen 500 mg, Do.
CP3 Oxycodone Hydrochloride 5 mg
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85P-0563/ Ibuprofen 300, 400, or 600 mg Do.
CP1
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85P-0581/ Acetaminophen 500 mg, Do.
CP1 Propoxyphene Hydrochloride 32 mg
------------------------------------------------------------------------
86P-0045/ Propranolol Hydrochloride 10, 20, Nutripharm, Inc.
CP1 40, 60, 80, 90 mg
------------------------------------------------------------------------
86P-0055/ Spironolactone 25 mg/5 mL Carolina Medical
CP1 Products Co.
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86P-0123/ Cholestyramine 4 grams (g) Parke-Davis, Division
CP1 of Warner-Lambert Co.
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86P-0200/ Acetaminophen 650 mg, Mikart, Inc.
CP1 Codeine Phosphate 15 mg
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86P-0242/ Floxuridine 500 mg/5 mL Quad Pharmaceuticals,
CP1 Inc.
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86P-0292/ Lorazepam 1 mg/5 mL Roxane Laboratories,
CP1 Inc.
------------------------------------------------------------------------
86P-0359/ Aspirin 356.4 mg, Central
CP1 Caffeine 30 mg, Pharmaceuticals, Inc.
Dihydrocodeine Bitartrate 16 mg
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86P-0361/ Acetaminophen 325 mg, Bock Pharmacal Co.
CP1 Aspirin 325 mg,
Codeine Phosphate 30 mg
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[[Page 8186]]
86P-0427/ Hydrochlorothiazide 50 mg, Par Pharmaceutical,
CP1 Triamterene 75 mg Inc.
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86P-0474/ Cholestyramine 500 mg Bristol-Myers Squibb
CP1
------------------------------------------------------------------------
87P-0004/ Fluocinonide 0.05% Richard Hamer Assoc.
CP1
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87P-0037/ Lorazepam 0.5 mg, 1 mg, 2 mg Applied Laboratories,
CP1 Inc.
------------------------------------------------------------------------
87P-0101/ Verapamil Hydrochloride 40 mg/5 mL MY-K Laboratories,
CP1 or 80 mg/5 mL Inc.
------------------------------------------------------------------------
87P-0233/ Verapamil Hydrochloride 120 mg or Searle Research &
CP1 240 mg Development
------------------------------------------------------------------------
87P-0242/ Ibuprofen 800 mg Sidmak Laboratories,
CP1 Inc.
------------------------------------------------------------------------
87P-0265/ Dexbrompheniramine Maleate 6 mg, Bock Pharmacal Co.
CP1 Phenypropanolamine Hydrochloride 75 (King & Spalding)
mg
------------------------------------------------------------------------
87P-0268/ Loperamide Hydrochloride 2 mg Kross, Inc.
CP1
------------------------------------------------------------------------
87P-0301/ Cholestyramine Resin 4 g Ciba-Geigy Corp.
CP1
------------------------------------------------------------------------
87P-0314/ Clemastine Fumarate 1.34 mg, Sandoz Consumer
CP1 Pseudoephedrine Hydrochloride 120 Healthcare Group
mg
------------------------------------------------------------------------
87P-0323/ Acetaminophen 160 mg/5 mL, Kleinfeld, Kaplan &
CP1 Codeine Phosphate 6 mg/5 mL Becker
------------------------------------------------------------------------
87P-0335/ Triamterene 50 mg, Par Pharmaceutical,
CP1 Hydrochlorothiazide 25 mg Inc.
------------------------------------------------------------------------
87P-0340/ Nifedipine 10 mg or 20 mg Do.
CP1
------------------------------------------------------------------------
87P-0367/ Phenytoin Sodium 100 mg, 250 mg/ Lyphomed, Inc.
CP1 vial
------------------------------------------------------------------------
87P-0399/ Propranolol Hydrochloride 40 mg or Burditt, Bowles,
CP1 80 mg/5 mL, Radzius & Rudberry
Hydrochlorothiazide 25 mg/5 mL
------------------------------------------------------------------------
88P-0011/ Cyclophosphamide 20 mg/mL, 500 mL Baxter Healthcare
CP1 pharmacy bulk pack (PBP) Corp.
------------------------------------------------------------------------
88P-0036/ Chlorhexidine Gluconate 0.5% Arent, Fox, Kinter,
CP1 Plotkin & Kahn
------------------------------------------------------------------------
88P-0061/ Homatropine Methylbromide 1.5 mg, Kleinfeld, Kaplan &
CP1 Hydrocodone Bitartrate 5 mg Becker
------------------------------------------------------------------------
88P-0149/ Leucovorin Calcium 1 mg/mL Roxane Laboratories,
CP1 Inc.
------------------------------------------------------------------------
88P-0277/ Quinidine Sulfate 300 mg A. H. Robins
CP1
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88P-0350/ Clemastine Fumarate 1.34 mg, Scientific Consulting
CP1 Phenylpropanolamine Hydrochloride of VA, Inc.
75 mg
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88P-0379/ Cyclophosphamide 20 mg/mL, 250 mL Baxter Healthcare
CP1 PBP Corp.
------------------------------------------------------------------------
88P-0391/ Prednisone 1 mg, 2.5 mg, 5 mg, 10 B.F. Ascher & Co.,
CP1 mg, 20 mg, 25 mg, or 50 mg Inc.
------------------------------------------------------------------------
89P-0028/ Hydrocortisone Valerate 0.2% McKenna, Conner &
CP1 Cuneo
------------------------------------------------------------------------
89P-0029/ Hydrocortisone Valerate 0.2% Do.
CP1
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89P-0071/ Morphine Sulfate 30 mg Ethypharm/Oxford
CP1 Research Intl. Corp.
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89P-0399/ Carbamazepine 200 mg/5 mL Guidelines, Inc.
CP1
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89P-0435/ Pentamidine Isethionate 100 mg/mL Astra Pharmaceutical
CP1 Products, Inc.
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90P-0049/ Hydrocortisone Acetate 2.5% or 1% Ferndale Laboratories,
CP1 Inc.
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90P-0084/ Chlorzoxazone 250 mg Mikart, Inc.
CP1
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90P-0154/ Hydrocortisone Acetate 1% Ferndale Laboratories,
CP1 Inc.
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90P-0198/ Clobetasol Propionate 0.05%, Kross, Inc.
CP1 RLD = Temovate
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[[Page 8187]]
90P-0436/ Nifedipine 30 mg, 60 mg, 90 mg KV Pharmaceutical Co.
CP1
------------------------------------------------------------------------
91P-0348/ Albuterol Sulfate 4 mg Richard Hamer
CP1 Associates, Inc.
------------------------------------------------------------------------
92P-0048/ Triazolam 0.125 mg/5 mL Roxane Laboratories,
CP2 Inc.
------------------------------------------------------------------------
92P-0101/ Hydrocortisone Acetate 2.5% Hogan & Hartson
CP1
------------------------------------------------------------------------
92P-0282/ Acetaminophen 150 mg, Mikart, Inc.
CP1 Aspirin 180 mg,
Hydrocodone Bitartrate 5 mg
------------------------------------------------------------------------
92P-0282/ Acetaminophen 150 mg, Do.
CP2 Aspirin 180 mg,
Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
92P-0282/ Acetaminophen 150 mg, Do.
CP3 Aspirin 180 mg,
Hydrocodone Bitartrate 2.5 mg
------------------------------------------------------------------------
92P-0282/ Acetaminophen 150 mg, Do.
CP4 Aspirin 180 mg,
Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
92P-0332/ Propranolol Hydrochloride 40 mg Flemington
CP1 Pharmaceutical Corp.
------------------------------------------------------------------------
92P-0335/ Albuterol Sulfate 2 mg, 4 mg WE Pharmaceuticals,
CP1 Inc.
------------------------------------------------------------------------
92P-0336/ Prednisone 5 mg or 10 mg Do.
CP1
------------------------------------------------------------------------
92P-0381/ Cytarabine 20 mg/mL, 12.5 mL Bristol-Myers Squibb
CP1 Co.
------------------------------------------------------------------------
92P-0500/ Timethoprim 25 mg/5 mL Ascent
CP1 Pharmaceuticals, Inc.
------------------------------------------------------------------------
93P-0048/ Cimetidine 200, 300, 400 or 800 mg Flemington
CP1 Pharmaceuticals Corp.
------------------------------------------------------------------------
93P-0049/ Propranolol Hydrochloride 10, 20, Do.
CP1 60, 80, 90 mg
------------------------------------------------------------------------
93P-0314/ Acetaminophen 500 mg, Mikart, Inc.
CP1 Codeine Phosphate 45 mg
------------------------------------------------------------------------
93P-0332/ Loperamide Hydrochloride 1 mg Asta Medica GmbH
CP1
------------------------------------------------------------------------
93P-0333/ Prednisone 1, 2.5, 20, 50 mg Dura Pharmaceuticals
CP1
------------------------------------------------------------------------
93P-0346/ Acetaminophen 325 mg, Mikart, Inc.
CP1 Butalbital 50 mg,
Caffeine 40 mg,
Hydrocodone Bitartrate 5 mg
------------------------------------------------------------------------
93P-0367/ Terfenadine 60 mg, Eurand America
CP1 Pseudoephedrine 120 mg
------------------------------------------------------------------------
93P-0446/ Morphine Sulfate 15 mg, 60 mg, 90 Ethypharm
CP1 mg, 100 mg
------------------------------------------------------------------------
93P-0459/ Methyltestosterone 25 mg ICN Pharmaceuticals,
CP1 Inc.
------------------------------------------------------------------------
94P-0182/ Acetaminophen 120 mg, WE Pharmaceuticals,
CP1 Codeine Phosphate 12 mg Inc.
------------------------------------------------------------------------
94P-0186/ Sulfamethoxazole 200 mg, Dura Pharmaceuticals
CP1 Trimethoprim 40 mg
------------------------------------------------------------------------
94P-0199/ Lorazepam 1 mg/10 mL Roxane Laboratories,
CP1 Inc.
------------------------------------------------------------------------
94P-0210/ Acetaminophen 150 mg, Mikart, Inc.
CP1 Aspirin 180 mg,
Codeine Phosphate 60 mg
------------------------------------------------------------------------
94P-0211/ Acetaminophen 150 mg, Do.
CP1 Aspirin 180 mg,
Codeine Phosphate 30 mg
------------------------------------------------------------------------
[[Page 8188]]
94P-0212/ Acetaminophen 150 mg, Do.
CP1 Aspirin 180 mg,
Codeine Phosphate 15 mg
------------------------------------------------------------------------
94P-0263/ Fluorouracil 5% Bradley
CP1 Pharmaceuticals, Inc.
------------------------------------------------------------------------
94P-0432/ Methylprednisolone 16 mg, 24 mg, 32 Dura Pharmaceuticals
CP1 mg
------------------------------------------------------------------------
94P-0433/ Leucovorin Calcium 10 mg/mL 350 mg Lederle Laboratories
CP1 vial
------------------------------------------------------------------------
94P-0433/ Leucovorin Calcium 10 mg/mL 5 mL Do.
CP2 vial
------------------------------------------------------------------------
95P-0008/ Captopril 25 mg/mL Roxane Laboratories,
CP1 Inc.
------------------------------------------------------------------------
95P-0100/ Carbidopa/Levodopa 25/100 mg, 25/ Athena Neurosciences,
CP1 250 mg Inc.
------------------------------------------------------------------------
95P-0223/ Hydrocortisone Butyrate 0.1% McKenna & Cuneo,
CP1 L.L.P.
------------------------------------------------------------------------
95P-0268/ Acyclovir Sodium 5 mg/mL Wilmer, Cutler,
CP1 Pickering
------------------------------------------------------------------------
95P-0277/ Cholestyramine 2 g Mayrand
CP1 Pharmaceuticals, Inc.
------------------------------------------------------------------------
95P-0279/ Butalbital 50 mg, Mikart, Inc.
CP1 Acetaminophen 325 mg,
Caffeine 40 mg,
Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
95P-0279/ Butalbital 50 mg, Do.
CP2 Acetaminophen 325 mg,
Caffeine 40 mg,
Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
95P-0279/ Butalbital 50 mg, Do.
CP3 Acetaminophen 500 mg,
Caffeine 40 mg,
Hydrocodone Bitartrate 10 mg
------------------------------------------------------------------------
95P-0279/ Butalbital 50 mg, Do.
CP4 Acetaminophen 500 mg,
Caffeine 40 mg,
Hydrocodone Bitartrate 7.5 mg
------------------------------------------------------------------------
95P-0326/ Nifedipine 30 mg, 60 mg, 90 mg KV Pharmaceutical Co.
CP1
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95P-0328/ Metronidazole 0.75% RNB Pharmaceutical Co.
CP1
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96P-0018/ Potassium Chloride 20 KV Pharmaceutical Co.
CP1 milliequivalents (meq)
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96P-0021/ Aspirin 650 mg Savage Laboratories,
CP1 Butalbital 50 mg Division of Altana,
Inc.
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96P-0054/ Potassium Chloride 10 meq KV Pharmaceutical Co.
CP1
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96P-0079/ Pentoxyfylline 400 mg Do.
CP1
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96P-0307/ Acyclovir 5% Pitney, Hardin, Kipp &
CP1 Szuch
------------------------------------------------------------------------
96P-0376/ Hydrocortisone Acetate 90 mg Do.
CP1
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96P-0510/ Diltiazem Hydrochloride 120 mg, 180 Labopharm, Inc.
CP1 mg, 240 mg,
RLD = Cardiazem CD
------------------------------------------------------------------------
97P-0155/ Mefenamic Acid 250 mg Pitney, Hardin, Kipp &
CP1 Szuch
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97P-0192/ Diltiazem Hydrochloride 120 mg, 180 Labopharm, Inc.
CP1 mg, 240 mg,
RLD = Dilacor XR
------------------------------------------------------------------------
97P-0195/ Diltiazem Hydrochloride 120 mg, 180 Do.
CP1 mg, 240 mg,
RLD = Tiazac
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97P-0387/ Albuterol Sulfate 2 mg and 4 mg Richard Hamer Assoc.,
CP1 Inc.
------------------------------------------------------------------------
97P-0404/ Famotidine 10 mg Thomas Blake, R.Ph.
CP1
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[[Page 8189]]
98P-0068/ Clobetasol Propionate 0.05%, Richard Hamer
CP1 RLD = Temovate E Associates, Inc.
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98P-0146/ Ifosfamide 50 mg/mL, 20 mL, and 60 Mitchall G. Clark
CP1 mL
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98P-0199/ Captopril 25 mg/5 mL Miran Consulting, Inc.
CP1
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98P-0745/ Econazole Nitrate 1% Do.
CP1
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This action is being taken without prejudice. Any of these
petitions may be resubmitted for action by the agency in accordance
with current law.
Dated: February 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-3043 Filed 2-22-07; 8:45 am]
BILLING CODE 4160-01-S