Daily FOI Log Control No: 98002868 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: M MARQUART Requester: BF GOODRICH CO Subject: ELI LILLY'S - HUMULIN N INSULIN NDA DATA Control No: 98002869 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFS22 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: COOPER VISION INC, SAN JOSE, CA - CAP 7C0209 Control No: 98002870 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: M KEVILLE Requester: CORAL THERAPEUTICS INC Subject: UNIVERSITY OF NORTH CAROLINA HOSPITALS, CHAPEL HILL, NC - EIR 1/16-22/98 & 1/96 Control No: 98002871 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: ELAN CORP, GAINESVILLE, GA - EIR, 483 & RESPONSE 8/25-9/17/97 Control No: 98002872 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP340 Signature: Requester: WARNER M Subject: OPILIO CRABS - LABORATORY RPT SAMPLE 98-738-124 Control No: 98002873 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP340 Signature: M SUN Requester: DIGITCARE CORP Subject: SJ MEDICAL - ENTRY NO 429-0805544-7 TEST RESULT Control No: 98002874 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP340 Signature: J GALINDO Requester: EUREKA FISHERIES INC Subject: EUREKA FISHERIES INC, COOS BAY, OR - EIRS LAST TWO Control No: 98002875 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: VINTAGE PHARMACEUTICALS INC, CHARLOTTE, NC - EIR & FIRM RESPONSE MOST RECENT Control No: 98002876 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFC300 Signature: Requester: PETZOLD D Subject: OIG # 95-OIA-970-008 - APPENDICES/ATTACMENTS & TRANS Control No: 98002877 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP240 Signature: Requester: FOI SERVICES INC Subject: ALMIL NUTRITIONAL, BREA, CA - EIR & 483 10/30/95 Control No: 98002878 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: ARROW PRODUCTS, HOLBROOK, NJ - EIR & 483 7/8/96 Control No: 98002879 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE140 Signature: Requester: FOI SERVICES INC Subject: ESTEE LAUDER, NY, NY - EIR, 483 & COMPANY RESPONSE 9/17-23/97 Control No: 98002880 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA140 Signature: Requester: FOI SERVICES INC Subject: NORWOOD COATED PRODUCTS, FRAZER, PA - EIR & 483 MOST RECENT Control No: 98002881 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE540 Signature: Requester: FOI SERVICES INC Subject: BIOVAIL LABS INC, CAROLINA, PR - EIR, 483 & RESPONSE 7/97 Control No: 98002882 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA140 Signature: Requester: FOI SERVICES INC Subject: WYETH-AYERST, RADNOR, PA - EIR & 483 1/97 TO PRESENT Control No: 98002883 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE340 HFRP240 Signature: Requester: FOI SERVICES INC Subject: MULTISORB TECHNOLOGIES, BUFFALO, NY - EIR, 483 & COMPANY RESPONSE 1/14/97 Control No: 98002884 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP240 Signature: Requester: FOI SERVICES INC Subject: ALPHA THERAPEUTIC, LOS ANGELES, CA - CONSENT CECREE 1/27/98 Control No: 98002885 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA240 Signature: Requester: FOI SERVICES INC Subject: AMERICAN LABORATORIES INC, CHANTILLY, VA - EIRS, 483S, WARNING LTRS, ETC 6/97 TO 12/97 Control No: 98002886 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW340 Signature: Requester: FOI SERVICES INC Subject: MEDTRONIC, MINNEAPOLIS, MN - EIRS & 483 1/95-3/96, 5/96-11/96 & 2/97 Control No: 98002887 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: ORTHO DIAGNOSTICS, RATITAN, NJ - EIRS & 483S 1/95 TO PRESENT Control No: 98002888 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: ORTHO PHARMACEUTICALS, RARITAN, NJ - EIRS & 483S 1/95 TO PRESENT Control No: 98002889 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFS22 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: LIST OF NAMES & ADDRESSES OF LOW ACID CANNED FOOD/ACIDIFIED MANUFACTURES Control No: 98002890 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA140 Signature: N PRYOR Requester: CACIQUE FOODS INC Subject: PUMPKIN SEED DRINK & CONDIMENT POWDER - LABORATORY RPTS Control No: 98002891 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HOECHST MARION ROUSSEL - SABRIL APRVL RVWS 11/26/97 Control No: 98002892 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE140 Signature: C BERGH Requester: GRAHAM-FILLED HEALTH PRODUCTS INC Subject: GRAHAM-FIELD INC, HAUPPAUGE, NY - EIR, 483, EXHIBITS, ETC 11/17/97 Control No: 98002893 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: DANBURY PHARMACAL - CAPTOPRIL & HYDROCHLOROTHIAZIDE USP TABS 50MG/25MG SBA, APRVL LTR, LBLG, PI, ETC 12/29/97 Control No: 98002894 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: DAILY FOI LOG 1/29/98 Control No: 98002895 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: LEMMON - CAPTOPRIL & HYDROCHLOROTHIAZIDE USP TABS 25MG/15MG ETC SBA, APRVL LTR, LBLG, PI, RVWS, ETC 12/29/97 Control No: 98002896 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ROYCE - ETODOLAC CAPS 200MG & 300MG SBA, APRVL LTR, LBLG, ETC 12/23/97 Control No: 98002897 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: G OEHLERT Requester: HOGAN & HARTSON Subject: WARNING LTRS 1/27/98 & IMPORT ALERTS 1/19/98 Control No: 98002898 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: WATSON LABS - CLONAZEPAM SUP TABS 0.5MG, 1MG & 2MG SBA EQUIV, APRVL LTR, RVWS, ETC 12/30/97 Control No: 98002899 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: RHOADES R, MARTINEZ, GA - EIR & 483 3/7/95 Control No: 98002900 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: CIPRO IV NDA 19-858 - APRVL LTR, MED RVW, PHARM RVW, ETC Control No: 98002901 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: ACCOLATE (ZAFIRLUKAST) - ADRS, TRADE & GENERIC DRUG NAMES, DATA ELEMENTS FOR EACH ENTRY-CONTROL NOS, ETC Control No: 98002902 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: ZYFLO (ZILEUTON) - ADRS, TRADE & GENERIC NAMES, DATA, ETC Control No: 98002903 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: ANNUAL ADVERSE DRUG EXPERIENCE RPT 1996 Control No: 98002904 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GOLDLINE OR ZENITH GOLDLINE - HALOPERIDOL SBA EQUIV, APRVL LTR, LBLG, ETC Control No: 98002905 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: NORPLANT - ADRS LAST 6 MONTHS Control No: 98002906 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: LODINE & LODINE XL - ADRS LAST 6 MONTHS Control No: 98002907 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PONDIMIN - ADRS LAST 6 MONTHS Control No: 98002908 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HOECHST MARION ROUSSEL - RIFADIN (RIFAMPIN) CAPS 300MG APRVL LTR, LBLG, CHEM RVW, ETC Control No: 98002909 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: EON - RIFAMPIN CAPS 300MG APRVL LTR, CHEM RVW, LBLG, ETC Control No: 98002910 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: LIST OF TREATMENT INVESTIGATION NEW DRUGS (INDS) MOST RECENT Control No: 98002911 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: OTC ACETAMINOPHEN - ADRS, TRADE & GENERIC NAMES, DATA, ETC Control No: 98002912 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: OTC IBUPROFEN - ADRS, TRADE & GENERIC NAMES, DATA, ETC 1984 TO PRESENT Control No: 98002913 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: MIKART INC, ATLANTA, GA - EIR, 483, FIRMS RESP MOST RECENT Control No: 98002914 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-33991 Control No: 98002915 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-39628 Control No: 98002916 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: BIOVAIL, MANITOBA, CANADA - EIR, 483, CO RESP 4/28-5/12/97 Control No: 98002917 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ALPHAPHARM - SELEGILINE HCL 5MG TAB/ANDA 74-866 SBA, APRVL LTR, RVWS ETC Control No: 98002918 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: KEY - IMDUR TABS 30, 60, & 120MG (ISOSORBIDE) PI MOST RECENT Control No: 98002919 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: WYETH - LODINE XL TABS 400 & 600MG (ETODOLAC) PI MOST RECENT Control No: 98002920 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: AMIDE PHARM - CARISOPRODOL AND ASPIRIN 200MG/325MG TAB/ANDA 40-252 SBA, APRVL LTR, RVWS ETC Control No: 98002921 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MOVA PHARM - GLYBURIDE USP/MICRONIZED/ANDA 74-591 SBA, APRVL LTR, RVWS ETC Control No: 98002922 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MERCK - PRILOSEC DELAYED RELEASE CAPS 10 & 20MG PACKAGE INSERT Control No: 98002923 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MERCK - MEVACOR TABS/LOVASTATIN PACKAGE INSERT Control No: 98002924 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA440 Signature: Requester: FOI SERVICES INC Subject: UNIVERSITY OF KY MEDICAL CNTR, LEXINGTON, KY - AZITHROMYCIN EIR & 483 1996 Control No: 98002925 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ABBOTT LABS - IOPAMIDOL/ANDA 74-898 & 74-636 SBA, APRVL LTR, RVWS ETC Control No: 98002926 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: BECLOVENT/BECLOMETHASONE DIPROPIONATE/N18-153 - APRVL RECS Control No: 98002927 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: LILLY - VANCOCIN ADD-VANTAGE (VANCOMYCIN HYDROCHLORIDE) DISCLOSABLE APRVL DOCS Control No: 98002928 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: CLEMASTINE FUMARATE SYRUP/N74-884 - SBA, APRVL LTR, RVWS ETC Control No: 98002929 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: INVAMED - METHYLPREDNISOLONE USP/ANDA 40-194 SBA, APRVL LTR, RVWS ETC Control No: 98002930 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ANTIBIOTICS - LIST MOST RECENT Control No: 98002931 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: VINTAGE PHARM - OXYBUTYNIN CHLORIDE USP/ANDA 75-079 SBA, APRVL LTR, RVWS ETC Control No: 98002932 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: DDMAC & PFIZER - ZOLOFT CORR 1997 Control No: 98002933 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: DURAMED - ACTAMINOPHEN & CODEINE PHOSPHATE USP/ANDA 40-223 SBA, APRVL LTR, RVWS ETC Control No: 98002934 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MONTORO R, CORAL GABLES, FL - EIR, 483 & CO RESP 6/10-19/97 Control No: 98002935 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: AESGEN - ACYCLOVIR TABS/ANDA 74-946 SBA, APRVL LTR, RVWS ETC Control No: 98002936 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: 5 Requester: FOI SERVICES INC Subject: HALSEY - HYDROCODONE BITARTRATE AND ACETAMINOPHEN USP/ANDA 40-240 SBA, RVWS, APRVL LTR ETC Control No: 98002937 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ADRIS RPT 184970, 187547, 187548 & 187549 ADRS Control No: 98002938 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: TEVA PHARM - ETODOLAC TABS/ANDA 75-009 SBA, APRVL LTR, RVWS ETC Control No: 98002939 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HYTRIN - ADRS Control No: 98002940 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: DUPONT CIRCLE PHYSICIANS GROUP, WASHINGTON, DC - EIR, 483 7/8-8/6/97 Control No: 98002941 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: R GOLDSTEIN Requester: WARSHAFSKY ROTTER TARNOFF ET AL Subject: RICHARDS MEDICAL CO; SMITH & NEPHEW ORTHOPAEDICS INC - PROSTHETIC KNEE IMPLANTS, TIBIAL INSERTS, COMPONENTS ADR, MRD, PRP, ETC CERTIFIED Control No: 98002942 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: LILLY - REOPRO APRVL RECS Control No: 98002943 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP240 Signature: Requester: OLIVERIO R Subject: BAXTER HEALTHCARE, MTN HOME, AZ - 483S LAST TWO Control No: 98002944 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ENDO LABS - CAPTOPRIL AND HYDROCHLOROTHIAZIDE UPS/ANDA 74-788 SBA, APRVL LTR, RVWS ETC Control No: 98002945 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE240 Signature: Requester: OLIVERIO R Subject: ARTHUR INC, NAPLES, FL - 483S LAST TWO Control No: 98002946 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: ALPHANATE - DISAPPROVAL LTR Control No: 98002947 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: ORTHO BIOTECH, RARITAN, NJ - EIRS, 483S 1/95 TO PRESENT Control No: 98002948 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE240 Signature: Requester: OLIVERIO R Subject: ASTRA USA, WESTBORO, MA - 483S LAST TWO Control No: 98002949 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: COPLEY - ACYCLOVIR CAPS/ANDA 74-914 SBA, APRVL LTR, RVWS ETC Control No: 98002950 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: L COLLINS Requester: CYBERONICS Subject: MEDTRONIC INC - ACTIVA TREMOR CONTROL SYSTEM MDR 7/31/97-PRESENT Control No: 98002951 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: OLIVERIO R Subject: CHROMOGNEIX AB, NYKOPING, SWEDEN - 483S LAST TWO Control No: 98002952 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: S HARTKA Requester: TERUMO MEDICAL CORP Subject: W L GORE INC - DIASTAT VASCULAR ACCESS GRAFT K953287 SS&E Control No: 98002953 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA140 Signature: Requester: OLIVERIO R Subject: WEST COMPANY, JERSEY SHORE, PA - 483S LAST TWO Control No: 98002954 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: NOCOTINE, NICORETTE, HAITROL, NICOTINELL, ETC ADRS THROUGH 12/97 Control No: 98002955 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFS22 Signature: Requester: FOI SERVICES INC Subject: HERSHEY - JOLLY RANCHER & TASTETATIONS; STORCK - WERTHERS; NABISCO - LIFESAVERS;BRACHS; NESTLE - NIPS; WARNER LAMBERT - FRUIT WAVES; FARLEY'S - CLEARY FRUIT CMPLNTS Control No: 98002956 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: S HARTKA Requester: TERUMO MEDICAL CORP Subject: W L GORE INC - DIASTAT VASCULAR ACCESS GRAFT K940824 SS&E Control No: 98002957 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA240 Signature: Requester: OLIVERIO R Subject: FUISZ TECHNOLOGIES LTD, CHANTILLY, VA - 483S LAST TWO Control No: 98002958 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: 98-2227, 98-2243, 97-2244 & 98-2539 - REQUEST LTR Control No: 98002959 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: S HARTKA Requester: TERUMO MEDICAL CORP Subject: W L GORE INC - DIASTAT VASCULAR ACCESS GRAFT K940062 SS&E Control No: 98002960 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: JANSSEN - MOR FOR SPORANOX CAPS (ITRACONAZOLE) PGS 9 & 73 9/21/92 Control No: 98002961 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: Requester: OLIVERIO R Subject: GRANUTEC, WILSON, NC - 483S SINCE 3/20-4/14/97 Control No: 98002962 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: S BUTCHOCK Requester: MEDICAL DEVICE REPORT Subject: WARNING LTRS WEEK OF 1/27/98 Control No: 98002963 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GLAXO WELLCOME - FLOVENT ROTADISK DISCLOSABLE APRVL Control No: 98002964 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: 98-2024 REQUEST LTR Control No: 98002965 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: BOEHRINGER MANNHEIM GMBH, GERMANY - 483S LAST TWO Control No: 98002966 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: 98-123 REQUEST LTR Control No: 98002967 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: E DELANE Requester: AAC CONSULTING GROUP INC Subject: FOI DAILY LOG 1/28/98; STERLING DRUG - WARNING LTR 3/30/98 Control No: 98002968 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SANOFI PHARMACEUTICALS INC - IRBESARTAN-HYDROCHLOROTHIAZIDE COMBINATION NDA 20-758 DISCLOSABLE APRVL 9/30/97 Control No: 98002969 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE140 Signature: Requester: OLIVERIO R Subject: PAR PHARMACEUTICALS, UPPER SADDLE, NY - 483S SINCE 10/9/96 Control No: 98002970 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: TARO PHARM USA INC - LTR 8/8/96 Control No: 98002971 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: A MATHER Requester: PATTON BOGGS LLP Subject: DKT 90N-0135 VOL 142 4 OF 15, REFS 65 & 66, ETC Control No: 98002972 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP140 Signature: Requester: OLIVERIO R Subject: BERLEX, RICHMOND, CA - 483S LAST TWO Control No: 98002973 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: DKT 97P-0441 Control No: 98002974 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE540 Signature: Requester: OLIVERIO R Subject: BRISTOL MYERS SQUIBB CO, MAYAGUEZ, PR - 483S LAST TWO Control No: 98002975 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFM48 Signature: M SALKA Requester: MEDICAL & LITIGATION CONSULTANTS Subject: RTPA/ALTEPLASE/ACTIVASE - RECS Control No: 98002976 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: DKT 97P-0441 C140-144, 98P-0043 CP1, 97N-0217 C80-C89, ETC Control No: 98002977 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: FERRING, MALMO, SWEDEN - 483S 10/10-16/97 Control No: 98002978 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE340 Signature: Requester: OLIVERIO R Subject: DANBURY PHARMACAL INC, CARMEL, NY - 483S LAST TWO Control No: 98002979 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFIMO Signature: T LANGFORD Requester: INSITE CLINICAL TRIALS INC Subject: CPGM 7348.809 & 7348.810 Control No: 98002980 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE540 Signature: Requester: OLIVERIO R Subject: DANBURY PHARMACAL INC, HUMACO, PR - 483S LAST TWO Control No: 98002981 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: PHARMACIA & UPJOHN - ROGAINE/ANDA 20-834 NEW FORMULATION RECS Control No: 98002982 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA340 Signature: Requester: OLIVERIO R Subject: DATASCOPE CORP, PARAMUS, NJ - 483S LAST TWO Control No: 98002983 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE240 Signature: Requester: OLIVERIO R Subject: R P SCHERER, ST PETERSBURG, FL - 483S 9/97 - 10/97 Control No: 98002984 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: K HEMMER Requester: CAPITOL INFORMATION SERVICES Subject: A/C ONCOLOGIC DRUGS - TRANS 12/18/97 Control No: 98002985 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE140 Signature: Requester: OLIVERIO R Subject: DUPONT MERCK PHARMA CO, GARDEN CITY, NY - 483 LAST TWO Control No: 98002986 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: SANKYO CHEMICAL INDUSTRIES LTD., JAPAN - 483S LAST TWO Control No: 98002987 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: A/C PULMONARY ALLERGY DRUGS - TRANS 12/15/97, ETC Control No: 98002988 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW340 Signature: Requester: OLIVERIO R Subject: SOLVAY, BAUDETT, MN - 483S 12//6/97 Control No: 98002989 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: DKT 97P-0429 PAV1 Control No: 98002990 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: K KAHL Requester: BYRON CHEMICAL COMPANY INC Subject: SINTESIS LERMA SA DE DV (GENSIA SICOR), LERMA, MIXICO - EIR, 483 1997 Control No: 98002991 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: DKT 84N-0201, 98M-0039 Control No: 98002992 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE340 Signature: Requester: OLIVERIO R Subject: VINTAGE PHARMACEUTICALS, INC, HUNTSVILLE, AL - 483S 7/21 - 8/1/97 Control No: 98002993 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: P LIEBERMAN Requester: CENTER FOR SCIENCE IN THE PUBLIC Subject: DKT 97N-0172 OB15, OB14, OB9, OB8, ETC Control No: 98002994 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: B LERNER Requester: MONTGOMERY SECURITIES Subject: BRISTOL-MYERS SQUIBB - GLUCAPHAGE/MEFORMIN ADVERSE EVENTS INCIDENCE MOST RECENT DATA/SUMMARY DATA Control No: 98002995 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA140 Signature: Requester: OLIVERIO R Subject: BIOSEARCH INC, PHILADELPHIA, PA - 483S 11/17/93 OR MOST RECENT Control No: 98002996 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: J COHEN Requester: KELLER & HECKMAN LLP Subject: DKT 97N-0268 C19 Control No: 98002997 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: DKT 78N-036L C189, 98P-0034 CP1, 98P-0043 CP1, ETC Control No: 98002998 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: ATHLONE, REPUBLIC OF IRELAND - 483 LAST TWO Control No: 98002999 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW240 Signature: Requester: OLIVERIO R Subject: BOEHRINGER-MANNHEIM, INDIANAPOLIS, IN - 483S 1/1/96 TO DATE Control No: 98003000 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA340 Signature: Requester: OLIVERIO R Subject: BECTON DICKINSON PHARMA, BRIDGEPORT, NJ - 483S LAST TWO Control No: 98003001 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: J LYDA Requester: PDA INC Subject: DKT 97N-0242 Control No: 98003002 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: Requester: AAC CONSULTING GROUP INC Subject: DKT 98D-0017, 98D-0021, 75N-183H VOL 61 RPT2, ETC Control No: 98003003 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW140 Signature: Requester: OLIVERIO R Subject: ANDERSON PACKAGING, ROCKFORD, IL - 483S LAST TWO Control No: 98003004 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW240 Signature: Requester: OLIVERIO R Subject: PALL GELMAN, ANN ARBOR, MI - 483S LAST TWO Control No: 98003005 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFM48 HFRSW240 Signature: R FITZGERALD Requester: ROBERT M FITZGERALD LAW OFFICE Subject: BELLE BONFILS MEMORIAL BLOOD CTR, DENVER, CO - INVESTIGATIONS, 483, BLOOD CONTAMINATION RPTS 1980-1995 Control No: 98003006 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW240 Signature: Requester: OLIVERIO R Subject: MESA LABS, WHEATRIDGE, CO - 483'S LAST TWO Control No: 98003007 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: D HASELY Requester: INSIDE WASHINGTON PUBLISHERS Subject: DKT 95N-0176 VOL 94 LET4, 95N-0304 VOL 286 C3526-C3528, ETC Control No: 98003008 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE240 Signature: Requester: OLIVERIO R Subject: PHARM ECO, LEXINGTON, MA - 483'S LAST TWO Control No: 98003009 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: A MATHER Requester: PATTON BOGGS LLP Subject: DKT 90N-0134 VOL 126 1 OF 3 REF 29, VOL 27 REF 7, ETC Control No: 98003010 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE240 Signature: B JACKSON Requester: W F JACKSON ASSOCS LTD Subject: ROCAP, DIV OF SABRATEK, WOBURN, MA - 483 12/12/97 Control No: 98003011 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW140 Signature: Requester: OLIVERIO R Subject: PHARMAGRAPHICS, ITASCA, IL - 483'S LAST TWO Control No: 98003012 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE140 Signature: Requester: OLIVERIO R Subject: LEDERLE LABS, PEARL RIVER, NY - 483'S LAST TWO Control No: 98003013 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW340 Signature: Requester: OLIVERIO R Subject: MEDCO LABS, SIOUX CITY, IA - 483'S LAST TWO Control No: 98003014 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW340 Signature: Requester: OLIVERIO R Subject: MEDTRONIC, PLYMOUTH, MN - 483'S LAST TWO Control No: 98003015 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE540 Signature: Requester: OLIVERIO R Subject: MEDTRONIC INC, HUMACAO, PR - 483'S LAST TWO Control No: 98003016 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE240 Signature: Requester: OLIVERIO R Subject: NOVAMETRIX MEDICAL SYSTEMS INC, WALLINGFORD, CT - 483'S LAST TWO Control No: 98003017 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: S HARTKA Requester: TERUMO MEDICAL CORP Subject: W L GORE INC - DIASTAT VASCULAR ACCESS GRAFT K953288 SS&E Control No: 98003018 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: L SCHILLER Requester: O'BRIEN & RYAN Subject: SILICONE/MEDICAL DEVICES CONFERENCE PROCEEDINGS 2/1-2/91 - PUB 92-4249; BRISTOL-MYERS SQUIBB CO - FINAL RPT ON PILOT STUDY OF URINE & SERUM SAMPLES FROM WOMEN W/ MEME/REPLICON BREAST IMPLANTS 7/14/95 Control No: 98003019 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE240 Signature: Requester: OLIVERIO R Subject: MICROTEST LABS, INC., AGAWAN, MA - 483S 7/18-19/95 & 8/20/96 Control No: 98003020 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE340 Signature: Requester: OLIVERIO R Subject: ONEIDA RESEARCH SERVICES, WHITESBORO, NY - 483S 2/18-24/97 & 6/17-19/97 Control No: 98003021 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE140 Signature: Requester: OLIVERIO R Subject: NOVARTIS PHARMACEUTICAL CORP, SUFFERN, NY - 483'S LAST TWO Control No: 98003022 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFIGC Signature: J SCHRIEL Requester: HEALTH PROTECTION BRANCH OF HEALT Subject: BOVINE SOMATOTROPIN - VMAC MINS OF MTG, SUMMARY 11/20-21/96, 5/29-30/96 Control No: 98003023 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW240 Signature: Requester: OLIVERIO R Subject: NUTRACEUTICALS, OGDEN, UT - 483'S LAST TWO Control No: 98003024 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: SPINE-TECH - (BAK) INTERBODY FUSION SYSTEM P950002/S003 Control No: 98003025 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: Requester: OLIVERIO R Subject: RUGBY LABS, NORCROSS, GA - 483'S LAST TWO Control No: 98003026 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: J KUESTER Requester: APOLLO INFORMATION SERVICE Subject: INTERNEURON PHARMS INC - REDUX SAFETY CORR 1996-1997 Control No: 98003027 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: K972352 & SS&E Control No: 98003028 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA340 Signature: Requester: OLIVERIO R Subject: ORTHO BIOTECH, INC, RARITAN, NJ - 483S 8/25-29/97 Control No: 98003029 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: J KUESTER Requester: APOLLO INFORMATION SERVICE Subject: AMERICAN HOME PRODS; WYETH-AYERST; A H ROBINS - PONDIMIN SAFETY CORR Control No: 98003030 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: PROFARMACO SRL, MILAN, ITALY - 483 LAST TWO Control No: 98003031 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: ESTEVE, BARCELONA, SPAIN - 483 LAST TWO Control No: 98003032 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: MERCK, DARMSTADT, GERMANY - 483 12/15-17/97 Control No: 98003033 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: THERATECHNOLOGIES - STETHOS K963621 Control No: 98003034 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: CARL ZEISS INC - HUMPHREY OCT SCANNER K961171 Control No: 98003035 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: PERCLOSE INC - MODIFIED PERCUTANEOUS VASCULAR SURGICAL DEVICE P960043/S001 Control No: 98003036 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: VOLTAREN - ADRS LAST 6 MONTHS Control No: 98003037 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: L KNEPPER Requester: BOZELL SAWYER MILLER GROUP Subject: FOREST PHARMACEUTICALS - CITALOPRAM NDA Control No: 98003038 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GLIPIZIDE - ADRS LAST 6 MONTHS Control No: 98003039 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW240 Signature: Requester: OLIVERIO R Subject: PARKE-DAVIS, ROCHESTER, MI - 483'S 12/96 OR MOST RECENT Control No: 98003040 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MEVACOR - ADRS LAST 6 MONTHS Control No: 98003041 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: A CONTIJOCH Requester: DESIGN WRITE INC Subject: ELI LILLY & CO - EVISTA/RALOXIFENE HCL NDA 20815 APRVL RECS Control No: 98003042 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PAXIL - ADRS LAST 6 MONTHS Control No: 98003043 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE240 Signature: Requester: OLIVERIO R Subject: PFIZER CENTRAL RESEARCH, GROTON, CT - 483'S 7/30/96 - 8/2/96 Control No: 98003044 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ZOLOFT - ADRS LAST 6 MONTHS Control No: 98003045 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: WYETH-AYERST, MONTREAL, CANADA - 483 LAST TWO Control No: 98003046 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: PHARMACIA & UPJOHN, MARION DEL TRONTO, ITALY - 483'S 8/25 - 9/1/97 Control No: 98003047 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PRILOSEC 40MG CAPS - DISCLOSABLE APRVL 1/98 Control No: 98003048 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: HAYL, SWITZERLAND - 483 LAST TWO Control No: 98003049 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA440 Signature: Requester: OLIVERIO R Subject: PHARMACIA HEPAR, INC., FRANKING, OH - 483'S 4/2-5/15/97 Control No: 98003050 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: HAYL, GERMANY - 483 LAST TWO Control No: 98003051 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SMITH W, PACIFIC NW CLINICAL RESEARCH CNTR, PORTLAND, OR - EIRS & 483S 12/88 TO PRESENT Control No: 98003052 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE340 Signature: Requester: OLIVERIO R Subject: RYSTAN INC, LITTLE FALLS, NY - 483'S LAST TWO Control No: 98003053 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PROZAC - ADRS LAST 6 MONTHS Control No: 98003054 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE240 Signature: Requester: OLIVERIO R Subject: STAR PHARMACEUTICALS, POMPANO BEACH, FL - 483'S LAST TWO Control No: 98003055 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: REDUX - ADRS LAST 6 MONTHS Control No: 98003056 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: EFFEXOR - ADRS LAST 6 MONTHS Control No: 98003057 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP240 Signature: Requester: OLIVERIO R Subject: STERIS LABS, PHOENIX, AZ - 483'S LAST TWO Control No: 98003058 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: L BLOCK Requester: GREY ADVERTISING Subject: ROCEPHIN IM - ADV EVENTS APRVL MOST RECENT Control No: 98003059 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW240 Signature: Requester: OLIVERIO R Subject: WILDLIFE LABS INC., FT. COLLINS, CO - 483'S LAST TWO Control No: 98003060 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: ZENITH/GOLDLINE PRALEX CORP., CHRISTIANSTED, VIRGIN ISLES - 483'S LAST TWO Control No: 98003061 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: DAIICHI PHARMACEUTICAL CO, SHIZUOKA, JAPAN - 483'S LAST TWO Control No: 98003062 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW240 Signature: Requester: OLIVERIO R Subject: HAUSER, BOULDER, CO - 483'S LAST TWO Control No: 98003063 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: I BLANCH Requester: LABORATORIOS DR ESTEVE Subject: PFIZER - ZOLOFT TABS TOXICOLOGICAL EVALUATION, CORR, ETC Control No: 98003064 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: Requester: FOI SERVICES INC Subject: HIMA-FDA PDP PUBLIC WORKSHOP - SUMMARY OF MINS 10/22/97 Control No: 98003065 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP140 Signature: Requester: OLIVERIO R Subject: DEY LABS, NAPA VALLEY, CA - 483'S LAST TWO Control No: 98003066 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: ORTO CONSERVIERA CAMERANESE Subject: ORTOCONSEVIERA CAMERANESE, CAMERANO, ITALY - EIR 5/5-9/97 Control No: 98003067 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: PERCLOSE INC - P960043/S003 Control No: 98003068 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP140 Signature: Requester: OLIVERIO R Subject: PROSURG, XIMED, CA - 483'S 1/7-27/97 Control No: 98003069 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: ACUSON CORP - HARMONIC IMAGING W/CONTRAST K973767 Control No: 98003070 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: SCHERING AG, BERLIN, GERMANY - 483 12/96 OR MOST RECENT Control No: 98003071 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW340 Signature: Requester: OLIVERIO R Subject: TEAM ASSOCS., STORY CITY, IA - 483'S LAST TWO Control No: 98003072 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW340 Signature: Requester: OLIVERIO R Subject: VETERINARY RESOURCES, INC, AMES, IA - 483'S LAST TWO Control No: 98003073 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: SIEGFRIED CHEMIE, ZORINGEN, SWITZERLAND - 483 2/17-20/97 Control No: 98003074 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFIDR Signature: D WISKE Requester: MEDOVATIONS Subject: PILLING CORP - MALONEY TUNGSTEN FILLED ESOPHAGEAL BOUGIE K932956 Control No: 98003075 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW440 Signature: Requester: OLIVERIO R Subject: KV PHARMACEUTICALS, MARYLAND HEIGHTS, MO - 483'S LAST TWO Control No: 98003076 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFIDR HFZ82 Signature: J CAPONE Requester: DIVERSIFIED BIOMEDICAL TECHNOLOGI Subject: VALLEY LAB INC - CUSA 200C ULTRASONIC ASPIRATOR K964601; FIBRA SONICS INC - ULTRASONIC LITHOTRIPTOR 300A K842024 Control No: 98003077 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI20 Signature: M WHITNEY Requester: COVINGTON & BURLING Subject: TALK PAPER T90-36 7/31/90 Control No: 98003078 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: DEBTOR Signature: J RIDDICK Requester: VHA INC Subject: KOSSAN LATEX INDUSTRIES, SELANGOR, MALAYSIA - EIR, 483, WARNING LTRS, ETC 8/1/96-PRESENT Control No: 98003079 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: J STERN Requester: KELLEY DRYE AND WARREN Subject: NATURAL LATEX/NATURAL RUBBER PRODS - 510K(S), MDR(S), CORR Control No: 98003080 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: J STERN Requester: KELLEY DRYE AND WARREN Subject: NATURAL LATEX/NATURAL PATIENT EXAM & SURGEON'S GLOVES - 510K(S), MDR(S), CORR Control No: 98003081 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: C MORRISON Requester: SALOMON SMITH BARNEY Subject: DKT 97P-0377 Control No: 98003082 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: BROWN T Subject: FOREVER TAN TANNING BED - OWNER'S MANUAL Control No: 98003083 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: D PARKIN Requester: SMITHKLINE BEECHAM Subject: JOHNSON & JOHNSON - NEW REACH ANTIBACTERIAL TOOTHBRUSH RECS Control No: 98003084 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: OLIVERIO R Subject: E-Z-EM INC, QUEBEC, CANADA - 483 LAST TWO Control No: 98003085 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: LANGSTON J Subject: ELECTRO & SONIC/CONVULSIVE DEVICE TREATMENTS - APRVL RECS, SUMMARIES, ETC Control No: 98003086 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: OLIVERIO R Subject: CREATE MEDIC CO LTD, HOKKAIDO, JAPAN - 483 LAST TWO Control No: 98003087 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: Requester: OLIVERIO R Subject: MEDTRONIC CANADA LTD, ONTARIO, CANADA - 483 9/29/97 Control No: 98003088 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP240 Signature: Requester: OLIVERIO R Subject: ICN PHARMS INC, COSTA MESA, CA - 483 LAST TWO Control No: 98003089 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP140 Signature: Requester: OLIVERIO R Subject: KC PHARM, POMONA, CA - 483 1/1/97-PRESENT Control No: 98003090 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW340 Signature: Requester: OLIVERIO R Subject: MEDTRONIC, MINNEAPOLIS, MN - 483 5/30/97 & 7/15-18/97 Control No: 98003091 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSW440 Signature: Requester: OLIVERIO R Subject: MALLINCKRODT, ST LOUIS, MO - 483 9/15-17/97 Control No: 98003092 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE540 Signature: Requester: OLIVERIO R Subject: ELECTRO-BIOLOGY INC, GUAYNABO, PR - 483 9/3/96-12/9/96 Control No: 98003093 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA140 Signature: Requester: OLIVERIO R Subject: ESI-PHARMA INC, PHILADELPHIA, PA - 483 LAST TWO Control No: 98003094 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFS22 Signature: Requester: FOI SERVICES INC Subject: GRAS #4G-0035 Control No: 98003095 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRP340 Signature: Requester: OLIVERIO R Subject: BARTELS, ISSAQUAH, WA - 483 3/24-28/97 Control No: 98003096 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA140 Signature: Requester: OLIVERIO R Subject: ADHESIVE RESEARCH, GLEN ROCK, PA - 483 12/10/97 Control No: 98003097 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFS22 Signature: Requester: FOI SERVICES INC Subject: IAMS PETFOOD CO - IMPORT OF LAMB/LAMB MEAL RECS 1994-PRESENT Control No: 98003098 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: 5 FOI FILES Control No: 98003099 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW240 Signature: Requester: OLIVERIO R Subject: ELI LILLY & CO, INDIANAPOLIS, IN - 483 LAST TWO Control No: 98003100 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 97-31189 Control No: 98003101 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE140 Signature: Requester: OLIVERIO R Subject: CIRRUS AIR TECH, LOCUST VALLEY, NY - 483 11/21-25/96 OR MOST RECENT Control No: 98003102 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-269 Control No: 98003103 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: Requester: OLIVERIO R Subject: ELAN PHARMA INC, GAINESVILLE, GA - 483 9/19/97 & 11/17/97 Control No: 98003104 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-41994 Control No: 98003105 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: Requester: OLIVERIO R Subject: THERAGENICS CORP, NORCROSS, GA - 483 11/19-25, 12/5/97 Control No: 98003106 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-31626 Control No: 98003107 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-41120 Control No: 98003108 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 97-34818 Control No: 98003109 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: K MORNINGSTAR Requester: MCKINLEY INC Subject: DKT 97N-0517 - TRANS 1/15/98 Control No: 98003110 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFZ82 Signature: D GRABARZ Requester: INTERNATIONAL REGULATORY CONSULTA Subject: PORGES S A, SARLAT, FRANCE - EIR 11/3-5/97 Control No: 98003111 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: Requester: FOI SERVICES INC Subject: A/C BIOLOGICAL RESPONSE MODIFIERS - MINS OF MTG 5/25-26/97 Control No: 98003112 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE140 Signature: Requester: OLIVERIO R Subject: GLAXO WELLCOME, RESEARCH TRIANGLE PARK, NC - 483 1/1/97-PRESENT Control No: 98003113 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA340 Signature: Requester: OLIVERIO R Subject: KNOLL LABS, MOUNT OLIVE, NJ - 483 LAST TWO Control No: 98003114 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA140 HFS22 Signature: H ROSSBACHER Requester: ROSSBACHER & ASSOCS Subject: HERSHEY FOOD PRODS - EIR, 483, COMPLAINTS, ETC 1996-PRESENT Control No: 98003115 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRSE240 Signature: Requester: OLIVERIO R Subject: HYPERION MEDICAL, ORLANDO, FL - 483 LAST TWO Control No: 98003116 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFS22 Signature: J BURKE Requester: UNILEVER UNITED STATES INC Subject: COASTAL NUTRITION LAB, PORTLAND, ME - BIOSLIM LTR DTD 10/10/97 Control No: 98003117 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMW240 Signature: Requester: OLIVERIO R Subject: HOUBA INC/SUBSIDIARY OF HALSEY DRUG CO, CULVER, IN - 483 LAST TWO Control No: 98003118 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: M MOORE Requester: BAXTER HEALTHCARE CORP Subject: A/C ENDOCRINOLOGIC & METABOLIC DRUGS - MINS OF MTG 3/3/86; A/C ALUMINUM TOXICITY MINS OF MTG 11/3/86; ETC Control No: 98003119 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: Requester: ROSAMILIA A Subject: DKT 97N-0296, VOL 62, PG 45593 Control No: 98003120 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFA305 Signature: Requester: FISHER E Subject: A/C OB/GYN - TRANS 2/22/73; A/C FERTILITY & MATERNAL HEALTH DRUGS - TRANS 6/17/92 Control No: 98003121 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRMA440 Signature: Requester: OLIVERIO R Subject: HEARTLAND HEALTHCARE SERVICES, TOLEDO, OH - 483 LAST TWO Control No: 98003122 Received Date: 02/02/98 Due Date: 03/03/98 Action Offices: HFRNE340 Signature: Requester: OLIVERIO R Subject: GRAHAM LABS, HOBART, NY - 483 LAST TWO Control No: 98003123 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSW140 Signature: J KOCH Requester: SPYRIDON KOCH WALLACE & PALERMO Subject: HOUSTON, TX - HUMAN TISSUE BANKS RPTS OF INSPECTIONS Control No: 98003124 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Z TOMER Requester: UNIPHARM LTD Subject: DORZOLAMIDE HYDROCHLORIDE - SBA & RVWS Control No: 98003125 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE140 Signature: Requester: FOI SERVICES INC Subject: EASTMAN CHEMICAL PRODUCTS INC, CHARLOTTE, NC - FORM 2656 Control No: 98003126 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: Requester: BATTLEBURY D Subject: POS-T VAC - APRVL Control No: 98003127 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: BERLICHEM, WAYNE, NJ - FORM 2656 Control No: 98003128 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE140 Signature: Requester: FOI SERVICES INC Subject: PRIDE SOLVENTS & CHEMICAL, HOLTSVILLE, NY - FORM 2656 Control No: 98003129 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: G THOMPSON Requester: HOME ACCESS HEALTH CORP Subject: HEALTH-MARK DIAGNOSTICS - CHOLESTOCHEK, TOTAL CHOLESTEROL SCREENING TEST RECS Control No: 98003130 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE340 Signature: Requester: FOI SERVICES INC Subject: CERES CHEMICAL CO INC, NY - FORM 2656 Control No: 98003131 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMW140 Signature: Requester: FOI SERVICES INC Subject: DOW CORNING, CHICAGO, IL - FORM 2656 Control No: 98003132 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: G THOMPSON Requester: HOME ACCESS HEALTH CORP Subject: CHEMTRAK - CHOLESTRAK HOME CHOLESTEROL TEST RECS Control No: 98003133 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA140 Signature: Requester: FOI SERVICES INC Subject: PARTICLE SIZE TECHNOLOGY, QUAKERTOWN, PA - FORM 2656 Control No: 98003134 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE140 Signature: Requester: FOI SERVICES INC Subject: NIPA HARDWICKE INC, CHARLOTTE, NC - FORM 2656 Control No: 98003135 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: K OLSON Requester: GINGRAS & CATES SC Subject: MFG PROCESS OF LATEX - LIST OF REGULATIONS & GDLNS ENFORCED BY FDA Control No: 98003136 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: CLEMENT R Subject: PHENOBARBITAL & DILANTIN - PRESCRIPTION APRVL POLICIES & PROCEDURES & SIDE EFFECTS Control No: 98003137 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: GANES CHEMICALS INC, CARLSTADT, NJ - FORM 2656 Control No: 98003138 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIDR HFZ82 Signature: Requester: FOI SERVICES INC Subject: MOLNYCKE CLNCL PRODS AB - MEPITEL NON-ADHERENT SILICONE DRESSING K914604 Control No: 98003139 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: D CARY Requester: CARY MEDICAL CORPORATION Subject: FLEMING - NEPHROCAPS SBA Control No: 98003140 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA440 Signature: Requester: FOI SERVICES INC Subject: QUANTUM CHEMICAL CORP, CINCINNATI, OH - FORM 2656 Control No: 98003141 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA340 Signature: G BERGT Requester: PENNFIELD ANIMAL HEALTH Subject: HOFFMAN-LAROCHE INC, NUTLEY, NJ - ANADA 200-140 Control No: 98003142 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIDR HFZ82 Signature: C VON HADEN Requester: SYBRON INTERNATIONAL CORP Subject: SCICAN - K910241, K945142, K962179, K915054, K944036, K964691 Control No: 98003143 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA340 Signature: G BERGT Requester: PENNFIELD ANIMAL HEALTH Subject: HOFFMAN-LAROCHE INC, NUTLEY, NJ - ANADA 200-167 Control No: 98003144 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: WINFIELD LABS INC - N-TERFACE K973538 510K SUMMARY Control No: 98003145 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MURO, PRELONE - DISCLOSBLE SUPPLEMENTS, N89-654 Control No: 98003146 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRP240 Signature: M BALBONI Requester: ALLERGAN INC Subject: ALLERGAN, IRVINE,CA - EIR 4/22-23/96 Control No: 98003147 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFC300 Signature: Requester: COLE M Subject: ILLEGAL ACTIVITIES - RPT Control No: 98003148 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA240 Signature: Requester: DOE J Subject: BLT# 0220 Control No: 98003149 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Z KHALAF Requester: ALGORITHM SAL PHARMACEUTICAL MANU Subject: ALGORITHM - CAPTOPRIL/HYDROCHLOROTHIAZIDE COMBINATION CLINICAL TRIALS, SBA, ETC Control No: 98003150 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MURO - PROLINE, SBA, APPRVL LTR, LBLG, PI, FINAL REVIEWS ETC. Control No: 98003151 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE240 Signature: S RICHTER Requester: MICRO TEST LABORATORIES INC Subject: LAPUCK LABS, WATERTOWN, MA - EIR MOST RECENT Control No: 98003152 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: P REICHERTZ Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: BRAINSTREE, GLOLYTELY; ABBOTT, OCL; DYNAPHARM, COLAVAGE; ETC - ADR Control No: 98003153 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: SOUCEK M Subject: HALCION - WORK OF YOUR IOM COMMITTEE Control No: 98003154 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: M NIELSEN Requester: SEDGWICK DETERT MORAN & ARNOLD Subject: SMITHKLINE BEECHAM - PHENTERMINE ADR Control No: 98003155 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FARMHISPANIA SA, BARCELONA, SPAIN - CO RESPONSE TO 483 FOR 2/12-14/96 Control No: 98003156 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 HFRNE240 Signature: S ISRAEL Requester: GLENWOOD-PALISADES Subject: POLYCHEM CORP, NEW HAVEN, CT - NDA, ANDA, SUPPL, WARNING LTRS, ETC Control No: 98003157 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: G PETERSON Requester: GARVEY ASSOCIATES INC Subject: TENOCARD, ASTRA-MERCK - TOCAINIDE HCL SBA Control No: 98003158 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SUMIKA FINE CHEMICALS, OSAKAM, JAPAN - EIR, & CO RESPONSE FOR 8/4-5/97 Control No: 98003159 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFICD Signature: J CASTRUCCI Requester: BIOMIRA USA INC Subject: INACTIVE INGREDIENT GUIDE Control No: 98003160 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: UPJOHN - FLORONE PG (DIFLORASONE) - SUPPLEMENTS N19-260 Control No: 98003161 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: M MANNEL Requester: LICHTWER PHARMA U S INC Subject: VALACICLOVIR & PENCICLOVIR - SBA Control No: 98003162 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: D MAHANEY Requester: HOPKINS & SUTTER Subject: SELFCARE INC - EARLY PREGNANCY TEST K955903 Control No: 98003163 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: UPJOHN, FLORONE OINTMENT (DIFLORASONE) - SUPPLEMENTS N17-994 Control No: 98003164 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA240 Signature: J MOTSAY Requester: MOTSAY & LAY Subject: CLAIM BLT 0026 Control No: 98003165 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: DERMIK - PSORCON (DIFLORASONE), SUPPLEMENTS N20-205 Control No: 98003166 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: MAHANEY Requester: HOPKINS & SUTTER Subject: SELFCARE INC - EARLY PREGNANCY TEST K960436 Control No: 98003167 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE240 Signature: D CUMMERFORD Requester: CHANDLER CHICCO AGENCY Subject: BAYER CORP, WEST HAVEN, CT - WARNING LTRS 1/97 TO PRESENT Control No: 98003168 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFICD Signature: T KRAUS Requester: IHS HEALTH INFORMATION Subject: INACTIVE INGREDIENT GUIDE Control No: 98003169 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: G PETERSON Requester: GARVEY ASSOCIATES INC Subject: BOEHRINGER INGELHEIM - MEXILETINE SBA OR RVWS Control No: 98003170 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: J DOWD Requester: HALE AND DORR Subject: REDA INSTRUMENTE GMBH - LAPROSCOPIC INSTRUMENTS K944706 Control No: 98003171 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE240 Signature: L POOLE-BRUBAKER Requester: CAMERICAN Subject: ENTRY# 958-00211542 - LAB ANALYSIS Control No: 98003172 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: MEDTRONIC INC - TEMPORARY PACEMAKER/IMPLANT TOOL MODEL 5318 K971474 Control No: 98003173 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE240 Signature: G MENENDEZ Requester: SACK & MENENDEZ INC Subject: ENTRY# 660-0437442-8 - ANALYST W/S Control No: 98003174 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFICD Signature: Requester: FOI SERVICES INC Subject: INACTIVE INGREDIENT GUIDE 1997 Control No: 98003175 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE240 Signature: Requester: ROSSI R Subject: THIN LINE INC, FL - RECS 7/19/93 TO PRESENT Control No: 98003176 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: UPJOHN - FLORONE (DIFLORASONE) SUPPLEMENTS, N17-741 Control No: 98003177 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: UPJOHN - FLORONE (DIFLORASONE), SUPPLEMENTS N19-259 Control No: 98003178 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE240 Signature: B HAIRE Requester: LEA PRODUCTS COMPANY INC Subject: ENTRY #110-6469150-2 - SPL RPT Control No: 98003179 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PEDIAPRED (PREDNISOLONE) - SUPPLEMENTS, N19-157 Control No: 98003180 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: SULZER OSCOR INC - PACE 101H K970497 Control No: 98003181 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE240 Signature: A NASH Requester: CALLICO DISTRIBUTORS Subject: ENTRY #112-9092186-3 - TEST RESULTS Control No: 98003182 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MURO - PRELONE 15 MG/5ML (PREDNISOLONE), SUPPLEMENTS Control No: 98003183 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFS22 Signature: S MIGUEL Requester: SGM ASSOCIATES Subject: AHMPAC LABS INC, LA CRESCENTA, CA - NU-MATERNA INFANT FORUMLAS DOCS Control No: 98003184 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFICD Signature: Requester: FOI SERVICES INC Subject: MOST RECENT IMPORT PRODUCT LIST - PRODUCT TRADE NAME & BY COUNTRY Control No: 98003185 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE440 Signature: D COHEN Requester: WWL RADIO Subject: SOUTHERN TRANSPLANTS INC AND/OR ORLEANS PARISH CORONERS - INVESTIGATOR RPTS Control No: 98003186 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: LIST OF CLINICAL INVESTIGATOR INSPECTIONS W/DEFICIENCY CODES, MOST RECENT Control No: 98003187 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIGC Signature: K REESE Requester: NATIONAL INSTITUTE OF NEUROLOGICA Subject: CPGM 7348.809 & 7348.810 Control No: 98003188 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GLAXO WELLCOME - WELLBUTRIN SR TABS 50MG, 100MG & 150MG, MOST RECENTLY APPROVD LBLG, N20-358 (S-003 & S-001) Control No: 98003189 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: C SALMORIN Requester: FAULDING INC Subject: BRISTOL-MYERS SQUIBB ONCLOLOGY - BLENOXANE ARPVL LBLG COMPONENTS Control No: 98003190 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SCHERING - IMDUR TABS 30MG, 60MG & 120MG, MOST RECENTLY APPRVD LBLG, N20-225 (S-004) Control No: 98003191 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: P REICHERTZ Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: C B FLEET CO INC - FLEET READY-TO-USE ENEMA ADR Control No: 98003192 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRP340 Signature: J WEST Requester: WESTERN OVERSEAS CORP Subject: ENTRY #906-4194433-6 - LAB RPT Control No: 98003193 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: PALADIN MEDICAL INC - MPC EXTERNAL TEMPORARY PACEMAKERS SYSTEM MODEL 7000 K970347 Control No: 98003194 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MEDICAL RESEARCH, DENVER, CO - DUBOFF E, M.D., EIRS & 483S 1/87-12/91 & 7/92 TO DATE Control No: 98003195 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: BIOTRONIK INC - ERA 3000 DUAL CHAMBER PACING SYSTEM ANALYZER K964190 Control No: 98003196 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SEATTLE CLINICAL RESEARCH CENTER, SEATTLE, WA - LONDBORG P, M.D., EIRS & 483S 1/87 TO DATE Control No: 98003197 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: ZOLL MEDICAL CORP - POWER CHARGER K934016 Control No: 98003198 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: P REICHERTZ Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: CB FLEET CO INC - PHOSPHO SODA LAZATIVE ADR Control No: 98003199 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: PACE MEDICAL - MODEL 4800 ACCUPACE PACING SYSTEM ANALYZER K925143 Control No: 98003200 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACIA & UPJOHN - CLEOCIN HYDROCHLORIDE CAPS 75MG BASE, 150MG, & 300MG BASE, MOST RECENTLY APPRVD LBLG, N50-162 (S-080) Control No: 98003201 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: OSCOR MEDICAL CORP - EXTERNAL DEMAND PACEMAKER K923621 Control No: 98003202 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: H GAY Requester: CHANDLER FRANKLIN & O'BRYAN Subject: IBUPROFEN - ADR Control No: 98003203 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSW440 Signature: D ROBERTS Requester: SMITHYMAN & ZAKOURA LAW OFFICES Subject: SALMONELLA OUTBREAK IN KS & MO - INVESTIGATION RECS Control No: 98003204 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HEALTH STUDIES, OKEMOS, MI - BIELSKI R, M.D., INSTITUTE, EIRS & 483S 1/87 TO DATE Control No: 98003205 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: LARK MARKETING SUPPORT SERVICES, SOMERSET, NJ - EIRS, 483S, CO RESPS ETC 1/1/95 TO PRESENT Control No: 98003206 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: RADIONICS INC - PACE 1A CARDIAC STIMULATOR K963579 Control No: 98003207 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: STEENBLOCK D Subject: WYETH AYESR - HYALURONIDASE TOXICOLOGY & ADVERSE REACTIONS Control No: 98003208 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA440 Signature: Requester: FOI SERVICES INC Subject: HOECHST MARION ROUSSEL, CINCINNATI, OH - EIRS, 483S, CO RESPS 10/95 AND 10/97 Control No: 98003209 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIMO Signature: T KRAUS Requester: IHS HEALTH INFORMATION Subject: WARNING LTRS & FOI LOG 2/16/98 Control No: 98003210 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L ORE Requester: NEW TECHNOLOGIES (SA-YSY) LTD Subject: EP MEDICAL INC - EP-3 CLNCL STIMULATOR K935590 Control No: 98003211 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SCHERING PLOUGH CORP - PROMETRIUM CAPS (PROGESTERONE) APPRVL DOCS N19-781 Control No: 98003212 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA240 Signature: Requester: FOI SERVICES INC Subject: CHESAPEAKE RESEARCH REVIEW INC, COLUMBIA, MD - EIRS, 483S 1/92 TO PRESENT Control No: 98003213 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIMO Signature: L BROWNE Requester: ICC INDUSTRIES INC Subject: EARTHNET, LEINER HEALTH PRODUCTS, NATURALIFE, ETC - WARNING LTRS Control No: 98003214 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRP240 HFZ82 Signature: C VON HADEN Requester: SYBRON INTERNATIONAL CORP Subject: TYCOM DENTAL (AKA TYCOM CORP), IRVINE, CA - EIR, 483, MDR, DEVICE LISTING, ETC Control No: 98003215 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: C VON HADEN Requester: SYBRON INTERNATIONAL CORP Subject: TYCOM DENTAL - K962031, K971319 Control No: 98003216 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: BATTELLE & RENWICK, WARREN, NJ - FORM 2656 ESTABLISHMENT REGISTRATION FORM Control No: 98003217 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFS22 Signature: C STAUFFER Requester: TECHNICAL FOODS CONSULTANTS Subject: GRAS SUBSTANCES - PENDING LIST Control No: 98003218 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: GIVAUDIN LAVIROTTE INC, CLIFTON, NJ - FORM 2656 ESTABLISHMENT REGISTRATION FORM Control No: 98003219 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFM48 Signature: M TOGNON Requester: UNIVERSITY OF FERRARA Subject: SV40 WORKSHOP - VIDEOTAPE Control No: 98003220 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE140 Signature: Requester: FOI SERVICES INC Subject: KATO WORLDWIDE LTD, MT VERNON, NY - FORM 2656 ESTABLISHMENT REGISTRATION FORM Control No: 98003221 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRP240 Signature: D COMMERFORD Requester: CHANDLER CHICCO AGENCY Subject: ALPHA THERAPEUTIC, LOS ANGELES, CA - 483S 1/97 TO PRESENT Control No: 98003222 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIDR HFZ82 Signature: K DAVIS Requester: PILLSBURY MADISON & SUTRO LLP Subject: ARTERIAL FILTER AFS-XXX/FILTER HOLDER AFS-HXX - K851003, COBE - CMS-FS MEMBRANE OXYGENATOR K926467 Control No: 98003223 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE240 Signature: D COMMERFORD Requester: CHANDLER CHICCO AGENCY Subject: BAYER CORP, W HAVEN, CT - 483S 1/97 TO PRESENT Control No: 98003224 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFA305 Signature: W GATES Requester: SEARLE Subject: A/C CARDIOVASCULAR & RENAL DRUGS MTG - TRANS 1/27/98 Control No: 98003225 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA140 HFZ82 Signature: C VON HADEN Requester: SYBRON INTERNATIONAL CORP Subject: SCICAN, PITTSBURGH, PA & TORONTO, ONTARIO - EIR, 483, MDR, DEVICE LISTING, ETC Control No: 98003226 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRSE240 Signature: D COMMERFORD Requester: CHANDLER CHICCO AGENCY Subject: NORTH AMERICAN BIOLOGICALS INC, MIAMI, FL - 483S 1/97 TO PRESENT Control No: 98003227 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA140 Signature: D COMMERFORD Requester: CHANDLER CHICCO AGENCY Subject: CENTEON, KING OF PRUSSIA, PA - 483S 1/97 TO PRESENT Control No: 98003228 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE240 HFZ82 Signature: G BLINN Requester: GENETICS INSTITUTE Subject: VERSI E, BOSTON, MA - EIR, 483 5/20-30/97, WARNING LTR 10/2/97 Control No: 98003229 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFS22 Signature: J CIMINO Requester: MAGIC STEAM CLEANING Subject: SODIUM HYDROXIDE - RECS Control No: 98003230 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRP240 Signature: D COMMERFORD Requester: CHANDLER CHICCO AGENCY Subject: BAXTER HEALTHCARE CORP, GLENDALE, CA - 483S 1/97 TO PRESENT Control No: 98003231 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMW240 Signature: D COMMERFORD Requester: CHANDLER CHICCO AGENCY Subject: IMMUNO-US INC, ROCHESTER, MI - 483S 1/97 TO PRESENT Control No: 98003232 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFA305 Signature: E KUSERK Requester: ECRI LIBRARY Subject: XENOTRANSPLANTATION MTG - TRANS 1/21&22/98 Control No: 98003233 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFV12 Signature: R HAMER Requester: RICHARD HAMER ASSOCIATES INC Subject: BIONICHE TERANTA, IRELAND - EIR & 483 1/1/95 TO DATE Control No: 98003234 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA240 HFZ82 Signature: G BLINN Requester: GENETICS INSTITUTE Subject: WARD D, WASHINGTON, DC - EIR, 483 8/6/97, WARNING LTR 11/20/97 Control No: 98003235 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE140 HFZ82 Signature: G BLINN Requester: GENETICS INSTITUTE Subject: RABIN J, MANHASSET, NY - EIR, 483 5/9-23/97, WARNING LTR 10/14/97 Control No: 98003236 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIGC Signature: M KOSONEN Requester: SICPA OY Subject: CFR TITLE 21 VOL 170-199 (FOOD ADDITIVES) Control No: 98003237 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFS22 Signature: H SUZUKI Requester: JAPANESE CONSUMERS CO-OPERATIVE U Subject: AGREVO INC - GLUFOSINATE TOLERANT CANOLE RECS Control No: 98003238 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIGC Signature: S CHERSTNIAKOVA Requester: UNIFORMED SERVICES UNIVERSITY OF Subject: TERFENADINE/N18-949 - RVWS Control No: 98003239 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFA305 Signature: J MCARDLE Requester: ALTERNATIVES RESEARCH & DEVELOPME Subject: A/C BIOLOGICAL RESPONSE MODIFIERS MTG - TRANS 12/17/97 Control No: 98003240 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFA305 Signature: J STONE Requester: CONCORDE MEDICAL GROUP Subject: A/C BLOOD PRODUCTS MTG - TRANS Control No: 98003241 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFM48 Signature: J TEITEL Requester: ST MICHAEL HOSPITAL Subject: ST MICHAEL HOSPITAL, ONTARIO, CA - EIR 3/21-2/2/97 Control No: 98003242 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIGC Signature: P CARLIN Requester: NORTH WEST PORK PRODUCTS Subject: LICENSE TO EXPORT TO THE USA Control No: 98003243 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIGC Signature: A MILNE Requester: BANCAMERICA ROBERTSON STEPHENS Subject: PRESCRIPTION DRUG USER FEE ACT OF 1992 Control No: 98003244 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: K THOMAS Requester: HORTON MADDOX & ANDERSON PLLC Subject: GLAXO WELLCOME - ZANTAC (RANITIDINE HYDROCHLORIDE), ADVRS Control No: 98003245 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFS22 Signature: B WALDMAN Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: COSMETIC PRODUCTS - CONSUMER CMPLNTS OR ADR Control No: 98003246 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFA305 Signature: G BERGT Requester: PENNFIELD ANIMAL HEALTH Subject: HOFFMAN-LA ROCHE - SULFATHIAZOLE SS&E Control No: 98003247 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: B FOSTER Requester: ZENECA PHARMACEUTICALS GROUP Subject: FDA US & US CLINICAL INSPECTIONS & CLASSIFICATION REPORTS - LATEST DOCS Control No: 98003248 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: PFIZER LTD, SANDWICH UK - 483S 4/97 - 9/97 Control No: 98003249 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: CENTEON PHARMA, MARBURG, GERMANY - 483S 1/1/97 TO DATE Control No: 98003250 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMA440 HFRSE340 HFZ82 Signature: O CARR Requester: GLANKLER BROWN ET AL Subject: CRYOMEDICAL SCIENCES INC - ACCUPROBE SYSTEMS, URETHRAL WARMING DEVICE RECS JACKSON-MADISON COUNTY GENERAL HOSPITAL, JACKSON, TN, ETC RECALL, RPT OF ADVERSE RCTN, INJURY, MALFUNCTION Control No: 98003251 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: Requester: OLIVERIO R Subject: SIMS, ITALY - 483S 10/2,3,6/97 Control No: 98003252 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: OLIVERIO R Subject: DAIWA, TOYAMA, JAPAN - 483S 5/96 OR MOST RECENT Control No: 98003253 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE340 Signature: M MORELLO Requester: MINOT FOOD PACKERS INC Subject: CLEMENT PAPPAS & CO, SEABROOK, NJ; CLIFFSTAR CORP, DUNKIRK, NY - RECS Control No: 98003254 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFS22 Signature: V BUCHANAN Requester: LEVIN MIDDLEBROOKS THOMAS ET AL Subject: EPHEDRINE OR MA HUANG - ADRS Control No: 98003255 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-426 Control No: 98003256 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: DOE J Subject: MARION MERRILL & DOW - TENUATE/DIETHYLPROPION ADRS Control No: 98003257 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: A SHERLEY Requester: OBER KALER GRIMES AND SHRIVER Subject: PROPOSED RULE PUBLISHED 1/30/89 AT 54 FR 4302 RE: MEDICARE COVERAGE OF CERTAIN MEDICAL DEVICES; MEDICARE COVERAGE OF UNAPPROVED AND INVESTIGATIONAL MEDICAL DEVICES RECS Control No: 98003258 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J HARNER Requester: TRAXX INTERNATIONAL CORPORATION Subject: IMPORT PRODUCT FILE SORTED BY COUNTRY & NDC NO. Control No: 98003259 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFI35 Signature: K JENSEN Requester: BLOOMBERG BUSINESS NEWS Subject: WARNING LTRS 2/3/98, IMPORT ALERTS 1/21/98 Control No: 98003260 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: L JOHNK Requester: HUTCHINSON BLACK & COOK LLC Subject: FOLLOW-UP OF 97-32996 Control No: 98003261 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: GARAY J Subject: SOLVAY PHARM, MARIETTA, GA - APPLICATION INTEGRITY POLICY RECS Control No: 98003262 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FARINELLA M Subject: GLAXO WELLCOME INC - ZYBAN NDA & AMENDMENTS Control No: 98003263 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: K NEMIRSKY Requester: COOK DUKE COX Subject: ACCUTANE (ISOTRETINOIN) - CASE REPORTS INVOLVING PSYCHOLOGICAL OR PSYCHIATRIC ADVRS Control No: 98003264 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J KAISER Requester: BOZELL SAWYER MILLER GROUP Subject: FLUOXETINE/PROZAC; SERTRALINE/ZOLOFT; PAROXETINE/PAXIL; FLUVOXAMINE/LUVOX; VENL-AFAXINE/EFFEXOR - CASE RPTS OF OVERDOSES Control No: 98003265 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J PADILLA Requester: SOLAR & FERNANDES Subject: ENDO PHARMACEUTICALS INC - DEAR DOCTOR OR DEAR PHARMACIST LTRS REF. NUBIAN Control No: 98003266 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: M CONEY Requester: SST CORP Subject: PROCOS SPA, NOVARA, ITALY - EIR, 483, CO RESP 7/97 Control No: 98003267 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: TATTERSALL M Subject: SORBITAN TRIOLEATE/SPAN 85 - LSIT OF MEDICAL PRODS USING AS A EXCIPIENT & LIST OF PRECLINICAL INHALATINO STUDIES Control No: 98003268 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: JABLONSKI K Subject: TERBUTALINE/BRETHIRE - ADRS Control No: 98003269 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFA305 Signature: Requester: DELEONARDIS M Subject: A/C ENDOCRINOLOGIC & METABOLIC DRUGS MTG - TRANS 9/28/95 & 11/16&17/95 Control No: 98003270 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFM48 Signature: S LYNCH Requester: PUGET SOUND BLOOD CTR Subject: ALTERNATE PROCEDURES UNDER 21 CFR 640.120 ALLOWING FOR ELECTRONIC CROSSMATCH - LIST OF APPROVED VARIANCES OR ALTERNATIVE PROCEDURES AND EXCEPTIONS, REVIEW AND APPROVAL CHECKLISTS ETC Control No: 98003271 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: A PFEILER Requester: NYCOMED AUSTRIA GMBH Subject: NYCOMED AUSTRIA - EIR, 481 3/10-13/97 Control No: 98003272 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFIGC Signature: M GALADARI Requester: MINISTRY OF HEALTH Subject: AUTONOMOUS ELECTRONIC STIMULATOR CAPS - DOCS, THERAPEUTIC USES ETC. Control No: 98003273 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFA305 Signature: J STONE Requester: CONCORDE MEDICAL GROUP Subject: BLOOD PRODS A/C MTG - TRANS Control No: 98003274 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: FARINELLA M Subject: ELAN CORP OR ELAN PHARM - NDAS OR ANDAS 1/1/94 TO PRESENT FOR OTC SMOKING CESS- ATION PATCH Control No: 98003275 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: Requester: HOLLIS D Subject: ALPHA STIM/CRANIAL ELECTRICAL STIMULATOR - APRVL RECS Control No: 98003276 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: MCLEOD L Subject: AUGMENTIN - STUDIES, & SIDE EFFECTS Control No: 98003277 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRMW240 Signature: D SCHOOLCRAFT Requester: HACKNEY & GROVER ATTY AT LAW Subject: BATTLE CREEK EQUIPMENT, BATTLE CREEK, MI - HEATING PAD/BLANKET, DOCS FROM 1988 TO DATE ETC. Control No: 98003278 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J KISTLER Requester: GLAXO WELLCOME Subject: JONES DR, INDIANAPOLIS, IN - EIRS, 483S, WARNING LTRS, CORR, & RESPONSES 1994-1998 Control No: 98003279 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: I BERRY Requester: WOCKHARDT AMERICAS INC Subject: WOCKHARDT LTD., AURANGABAD, INDIA - EIR 1/25-28/98 Control No: 98003280 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J KISTLER Requester: GLAXO WELLCOME Subject: EDWARDS T, ALBANY NY - EIRS, 483S, WARNING LTRS, CORR, & RESPONSES 1994-1998 Control No: 98003281 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: L CIEUTAT Requester: UNGAR R & ASSOCIATES INC Subject: INVA-CARE - AMBASE-XT CHAIR, COMPLAINTS, RECALLS, ETC. Control No: 98003282 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: DEBTOR Signature: T STOMBAUGH Requester: IMPRA INC Subject: CHANGES IN MEDICAL DEVICE TRACKING & POSTMARKET SURVEILLANCE AUTHORITY MTG - TRANS 1/15/98 Control No: 98003283 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFRNE240 Signature: M SMITH Requester: FENWICK & WEST Subject: BIOPURES - OXYGLOBIN, EIRS/483S 1/1/96 TO DATE Control No: 98003284 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: Requester: DAVIS L J Subject: SMITHKLINE BEECHAM - CIMETIDINE; GLAXO WELLCOME - TAGAMET HB; RANITIDINE, WARNER WELLCOME - ZANTAC 75; & JOHNSON & JOHNSON-MERCK - ZANTAC 75 - WARNING LTRS ISSUED BTWB 1993 &1996 Control No: 98003285 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: K HANLEY Requester: BURCHETTA BROFMAN & HANLEY Subject: MCNEIL CONSUMER PRODUCTS CO - ULTRAM DOCS Control No: 98003286 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: T KOMORI Requester: CHUGAI PHARMACEUTICAL CO LTD Subject: SANDOZ - FLUVASTATIN; MERCK & CO - LOVASTATIN; BRISTOL MYERS SQUIBB - PRAVASTATIN; MERCK & CO - SIMVASTATIN, APPRVL DOCS TOXICOLOGY STUDIES GENOTOXICITY & CARCINOGENICITY STUDIES, ETC. Control No: 98003287 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: E PETERS Requester: MATTSON JACK TECHNICAL SERVICES Subject: ANZEMET, HOECHST MARION ROUSSEL - DOLASETRON MESYLATE FOR INJ, MORS, NDA 20-624 NDA 20-263 Control No: 98003288 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFZ82 Signature: D ALEKNAVAGE Requester: HOGAN & HARTSON Subject: STAR MEDICAL TECHNOLOGIES INC, RALEIGH, NC - STARLIGHT PULSED DIODE ARRAY LASER SYSTEM, SS&E K973324 Control No: 98003289 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFA305 Signature: L GILBERT Requester: ALCON LABORATORIES INC Subject: DKT # 84N-02102 Control No: 98003290 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: PENEDERM - MENTAX CREAM (BUTENATINE), SBA AND/OR EQUIVALENT 11/97 Control No: 98003291 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: TARO PHARMACEUTICALS - TRIAMCINOLONE CREAM, SBA AND/OR EQUIVALENT 11/97 Control No: 98003292 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: GLAXO WELLCOME - FLONASE SPRAY (FLUTICASONE) SBA AND/OR EQUIVALENT 11/97 Control No: 98003293 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: CLAY PARK LABS - BETAMETHASONE DIPROPIONATE CREAM, SBA AND/OR EQUIVALENT 11/97 ANDA APPRVL Control No: 98003294 Received Date: 02/03/98 Due Date: 03/04/98 Action Offices: HFM48 Signature: M SMITH Requester: FENWICK & WEST Subject: BIOPURES - OXYGLOBIN, APPRVL PACKAGE Control No: 98003295 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MEPROBAMATE - ADR Control No: 98003296 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PYRILAMINE - ADR Control No: 98003297 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SMITHKLINE BEECHAM PHARMACEUTICALS - PAXIL APRVL RECS Control No: 98003298 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMA340 Signature: Requester: FOI SERVICES INC Subject: ARENOL CHEMICAL CORP, SOMMERILLE, NJ - QUALITY ASSURANCE PROFILE Control No: 98003299 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MEPERIDINE - APRVL RECS Control No: 98003300 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACIA & UPJOHN - TRELLASAR APRVL RECS Control No: 98003301 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MORTON GROVE PHARMACEUTICALS - LOPERAMIDE APRVL RECS Control No: 98003302 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PFIZER - ZOLOFT SERTRALINE LONG TERM USE RECS Control No: 98003303 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFA430 Signature: Requester: FOI SERVICES INC Subject: BONE H - CURRICULUM VITAE Control No: 98003304 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PROZAC - LONG TERM USE RECS Control No: 98003305 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MORTON GROVE PHARMACEUTICALS - CIMETIDINE APRVL RECS Control No: 98003306 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ASTRA MERCK - PRILOSEC DDMAC NOTICE OF VIOLATION LTRS Control No: 98003307 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: QUAZEPAM - ADR Control No: 98003308 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MYLAN PHARMACEUTICALS - NITROFURANTOIN APRVL RECS Control No: 98003309 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MYLAN PHARMACEUTCALS - ETODOLAC APRVL DOCS Control No: 98003310 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: 3M - CLIMARA/ESTRADIOL NDA 20375 RECS Control No: 98003311 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: ALPHARMA INC - ACTICIN APRVL RECS Control No: 98003312 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MYLAN PHARMACEUTICALS - PENTOXIFYLLINE APRVL DOCS Control No: 98003313 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MYLAN PHARMACEUTICALS - RANITIDINE APRVL DOCS Control No: 98003314 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFS22 Signature: Requester: FOI SERVICES INC Subject: BIO-CIDE - ACIDIFIED SODIUM CL SOL FAP 8A4568 Control No: 98003315 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MYLAN PHARMACEUTICALS - CAPTOPRIL & HYDROCHLOROTHIAZIDE APRVL DOCS Control No: 98003316 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MYLAN PHARMACEUTICALS - DILTIAZEM APRVL DOCS Control No: 98003317 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: NOVOPHARM - TERFENADINE APRVL DOCS Control No: 98003318 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: KUOISYN - APRVL LTR, MEDICAL RVW, PHARMACOLOGY RVW, ETC Control No: 98003319 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: 98-687 Control No: 98003320 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRSE140 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: ELEMENTAL RESEARCH INC, CANADA - EIR, 483 & CO RESPONSE 1985 TO DATE Control No: 98003321 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRSW140 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: CHEMICALS INC, BAYTOWN, TX - EIR, 483 7 CO RESPONSE 1985 TO DATE Control No: 98003322 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRNE340 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: NYCOMED INC, RENSSELAER, NY - EIR, 483 & CO RESPONSE 1985 TO DATE Control No: 98003323 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMA140 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: ZENECA, NEW CASTLE, DE - EIR, 483 & CO RESPONE 1985 TO DATE Control No: 98003324 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: SURGICAL NAVIGATION TECHNOLOGIES - STEALTHSTATION SYSTEM K972398 Control No: 98003325 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMA140 Signature: E DELANEY Requester: FOI SERVICES INC Subject: PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES, HORSHAM, PA - EIR, 483 & CO RESPONSE 1985 TO DATE Control No: 98003326 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: SURGICAL NAVIGATION TECHNOLOGIES - STEALTHSTATION DRILL ATTACHMENT K974161 Control No: 98003327 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMA140 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: NETZSCH, EXTON, PA - EIR, 483 & CO RESPONSE 1985 TO DATE Control No: 98003328 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFA430 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: FITZSIMMONS J - SF 171 &/OF CURRICULUM VITAE Control No: 98003329 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ROBERTS LAB INC - PROAMATINE APRVL LTR, LBLG, MEDICAL OFFICER RVW, ETC Control No: 98003330 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFA306 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: DATTEL B, FALK R, HAMMOND M, ETC - CURRICULUM VITAE Control No: 98003331 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: SURGICAL NAVIGATION TECHNOLOGIES - DISPOSABLE BIOPSY NEEDLE K971247 Control No: 98003332 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: ACCESS FRAMEWAVE - K972925 Control No: 98003333 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: ALGOTEC SYSTEMS - MEDISURF K971347 Control No: 98003334 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: PANCREASE - ADR Control No: 98003335 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: VCOM SYSTEMS INC - REALVIEW TELEMEDICINE SYSTEM K973065 Control No: 98003336 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: LEVOFLOXACIN - ADR Control No: 98003337 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ERYTHROPOIETIN - ADR Control No: 98003338 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: RENOVA - ADR Control No: 98003339 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ULTRAM - ADR Control No: 98003340 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: J ATULOBI Requester: FDC REPORTS INC Subject: WARNING LTRS ON DISK & PAPER WEEK OF 2/3/98; IMPORT ALERTS WEEK OF 2/3/98 Control No: 98003341 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFICD Signature: I AMPOFO Requester: HALSEY DRUG COMPANY INC Subject: INACTIVE INGREDIENT GUIDE Control No: 98003342 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: I KLUGE Requester: HYMAN PHELPS & MCNAMARA PC Subject: WARNING LTRS WEEK OF 2/3/98; IMPORT ALERTS WEEK OF 2/3/98 Control No: 98003343 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMA140 Signature: L JONES Requester: INHALON PHARMACEUTICALS INC Subject: INHALON PHARMS INC, BETHLEHAM, PA - EIR 3/96 Control No: 98003344 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: MART RPT 1/98 Control No: 98003345 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: TOPAMAX - ADR Control No: 98003346 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFIMO Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: FOI DAILY LOG 1/26-30/98; IMPORT ALERTS 1/26/98; WARNING LTRS 2/3/98 Control No: 98003347 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: K GEORGE Requester: SOFTWARE QUALITY MANAGEMENT INC Subject: WARNING LTRS WEEK OF 2/3/98 Control No: 98003348 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: ADVIL - LBLG 1993-1994 Control No: 98003349 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: J COHEN Requester: KELLER & HECKMAN LLP Subject: WARNING LTRS WEEK OF 2/3/98 Control No: 98003350 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFS22 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: JOHNSON & JOHNSON - NO MORE TEARS BABY SHAMPOO ADVERSE EXPERIENCES RPT Control No: 98003351 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: J DICKINSON Requester: FERDIC INC Subject: FOI DAILY LOG 1/26-2/2/98; WARNING LTRS WEEK OF 2/3/98 Control No: 98003352 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 7 FOI REQUEST LTRS Control No: 98003353 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 10 FOI REQUEST LTRS Control No: 98003354 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: J BUKAWSKI Requester: WASHINGTON BUSINESS INFORMATION Subject: IMPORT ALERTS WEEK OF 1/26/98; WARNING LTRS WEEK OF 2/3/98; FOI DAILY LOG 1/27- 2/2/98 Control No: 98003355 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 10 FOI REQUEST LTRS Control No: 98003356 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: FOI DAILY OF DISK; WARNING LTRS WEEK OF 2/3/98 Control No: 98003357 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 10 FOI REQUEST LTRS Control No: 98003358 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: NETZSCH, GERMANY - EIR, 483, CO RESP 1985-PRESENT Control No: 98003359 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: IMPORT ALERTS WEEK OF 1/26/98; WARNING LTRS WEEK OF 2/3/98; FOI DAILY LOG 1/26- 2/2/98 Control No: 98003360 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: S DICKERSON Requester: FOI SERVICES INC Subject: WARNING LTRS WEEK OF 2/3/98 Control No: 98003361 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: 11 FOI REQUEST LTRS Control No: 98003362 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRP240 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: WEST COAST ANALYTICAL SERVICES INC, SANTA FE SPRINGS, CA - EIR, 483, CO RESP 1985-PRESENT Control No: 98003363 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: WARNING LTRS 2/2/98 Control No: 98003364 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: M WEITZMAN Requester: INCAD INC Subject: WARNING LTRS ON PAPER & DISK WEEK OF 2/3/98; FOI DAILY LOG ON PAPER & DISK 1/26-30/98 Control No: 98003365 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: CNS INC - BREATHE RIGHT NASAL STRIP K955711 RECS Control No: 98003366 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: K REID Requester: WASHINGTON INFORMATION SOURCE CO Subject: FOI DAILY LOG ON DISKETTE Control No: 98003367 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: CNS INC - BREATHE RIGHT NASAL STRIP K953772 Control No: 98003368 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: M WEITZMAN Requester: INCAD INC Subject: WARNING LTRS ON PAPER & DISK WEEK OF 1/20/98 & 1/27/98; FOI DAILY LOG ON PAPER & DISK 1/12-23/98 Control No: 98003369 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: M BAFFOUR Requester: SANDOZ/NOVARTIS Subject: WARNING LTRS 2/3/98 Control No: 98003370 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: CNS INC - BREATHE RIGHT NASAL STRIP K964914 RECS Control No: 98003371 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFI35 Signature: S SCHNEIDERMAN Requester: FDC REPORTS INC Subject: ROBERTS PHARMACEUTICAL - WARNING LTR 12/31/97 Control No: 98003372 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFM48 HFRP240 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: COLLATERAL THERAPEUTICS &/OR CRYSTAL, R - RELEASABLE SUBMISSIONS Control No: 98003373 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: A THOMAS Requester: OTSUKA AMERICA PHARMACEUTICAL INC Subject: KNOLL PHARM - MERIDIA/SIBUTRAMINE/N20-632; GATE PHARM - ADIPEX-P RVWS, NOTES ETC Control No: 98003374 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: T OGASAWARA Requester: SANWA KAGAKU KENKYUSHO CO LTD Subject: ABBOTT LABS - CYLERT/PEMOLINE MEDWATCH RPTS 1975 TO 5/96 Control No: 98003375 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRNE240 Signature: Requester: FOI SERVICES INC Subject: TOM'S OF MAINE, KENNEBUNKPORT, ME - EIRS, 493S, COMPLIANCE ACTIVITY 1/90-PRESENT Control No: 98003376 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMW240 Signature: Requester: FOI SERVICES INC Subject: ACCRA PAC, ELKHART, IN - EIR, 483, WARNING LTR MOST RESENT Control No: 98003377 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: DPT - EMBELINE/CLOBETASOL ANDA 74222 APRVL LTR, LBLG, PI, ETC Control No: 98003378 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: DPT - EMBELINE/CLOBETASOL ANDA 74221 APRVL LTR, LBLG, PI, ETC Control No: 98003379 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: K YAMADA Requester: ASAHI CHEMICAL INDUSTRY CO LTD Subject: WYETH-AYERST - REDUX/DEXFENFLURAMINE HCL; ROBINS - PONDIMIN/FENFLURAMINE HCL; SMITHKLINE BEECHAM - FASTIN/PHENTERMINE; ABBOTT LABS - DESOXYN GRADUMET/METHAM- PHETAMINE HCL; NOVARTIS - SANOREX/MAZINDOL APRVL PACKAGES Control No: 98003380 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C LEE Requester: FDC REPORTS INC Subject: WYETH-AYERST - PREMPRO RVWS Control No: 98003381 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HEALTHPOINT LTD - CORMAX CREAM/CLOBETASOL ANDA 74220 APRVL LTR, LBLG, PI, ETC Control No: 98003382 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HF35 Signature: T LOPEZ Requester: LOPEZ DISTRIBUTION Subject: LIST OF ORPHAN DRUGS, SPONSORS AND BIOLOGICAL DESIGNATION Control No: 98003383 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HOECHST MARION ROUSSEL - ALLEGRA-D/FEXOFENADINE HCL & PSEUDOEPHEDRINE HCL N20786 APRVL RECS Control No: 98003384 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFA305 Signature: D WATERS Requester: ROSEMONT PHARMACEUTICAL CORP Subject: PHARMACEUTICAL SCIENCE A/C MTG - TRANS 12/11-12/97 Control No: 98003385 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: J LOCKWOOD Requester: GRAY & RITTER Subject: ETHICON INC OR JOHNSON & JOHNSON INC - RPTS, NOTES, CORR ETC Control No: 98003386 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: LIPITOR/ATORVASTATIN - ADR Control No: 98003387 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: P MALONE Requester: STEIN MITCHELL & MEZINES LLP Subject: MITYVAC; MITYVAC-M; CMI SOFT TOUCH; SILASTIC SOFT CUP; SOFT TOUCH; TENDER TOUCH ULTRA; SILC - ADRS Control No: 98003388 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: CLNCL INVESTIGATOR INSPECTIONS 6/77-PRESENT Control No: 98003389 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: AZELASTINE - ADR Control No: 98003390 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: BEPRIDIL - ADR Control No: 98003391 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: CARISOPRODOL - ADR Control No: 98003392 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 HFRP340 Signature: Requester: ARTHUR M HOROWITZ & ASSOCS Subject: BORISON R, DIAMOND B & FIDDES R - 483, EIR & CO RESP; WESTERN IRB, OLYMPIA, WA 483, EIR & CO RESP Control No: 98003393 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFIDR Signature: L SCOTT Requester: JEFFERSON PILOT LIFE INSURANCE Subject: TERM GUARD II K893770 11/3/89 & TERM GUARD 5000 K843011 11/1/84 Control No: 98003394 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HOVIONE, LOURES, PORTUGAL - EIR, 483 & WARNING LTRS MOST RECENT Control No: 98003395 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FARMABIOS, GROPELLO, ITALY - EIR, 483 & WARNING LTR MOST RECENT Control No: 98003396 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: TEVA PHARMACEUTICALS, JERUSALEM, ISRAEL - EIR 11/97 Control No: 98003397 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFA305 Signature: Requester: FOI SERVICES INC Subject: BIOEQUIV ADVISORY MTG - MINS 8/15/96 OR 12/11-12/97 Control No: 98003398 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: LOHMANN, ANDERNACH, GERMANY - EIRS,483S, CO RESP,ETC 1/95 TO PRESENT Control No: 98003399 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRSE140 Signature: Requester: INFORMATION ACCESS Subject: ELAN CORP, GAINESVILLE, GA - WARNING LTR, EIR, 483, CORR, ETC 11/7/97 Control No: 98003400 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: SHCERING - MACMIS ID 4636 (UNI-DUR) CORR 5/13/97 Control No: 98003401 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: HOECHST MARION ROUSSEL - MACMIS ID 3956 (SELDANE) CORR 5/22/96 TO PRESENT Control No: 98003402 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: MITSUBISHI CHEMICAL CORP, KASHIMA - ARGATROBAN EIR,483, CO RESP 12/8-9/97 Control No: 98003403 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: LEK, LJUBLJAMA SLOVINIA - BROMOCRIPTINE MESYLATE EIR, 483, CO RESP 7/97 Control No: 98003404 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRSE240 Signature: Requester: INFORMATION ACCESS Subject: CHEMINOVA - SKIN-CAP CORR 7/1/97 TO PRESENT Control No: 98003405 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFA306 Signature: Requester: INFORMATION ACCESS Subject: A/C - ONCOLOGIC DRUGS LIST OF MEMBERS & CURRICULUM VITAES MOST RECENT Control No: 98003406 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: NICOTINE - ADRS,TRADE & COMBINATION PRODUCTS, ETC Control No: 98003407 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: GLAXO WELLCOME - ZYBAN (BUPROPION) ADRS Control No: 98003408 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: UPJOHN - ANSAID (FLURBIPROFEN) ADRS Control No: 98003409 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: ACETAMINOPHEN - ADRS, TRADE & COMBINATION PRODUCTS, ETC Control No: 98003410 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: A MCHUGHEN Requester: UNIVERSITY OF SASKATCHEWAN Subject: NPT-II/APH(3)II - RVWS Control No: 98003411 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: KETOPROFEN - ADRS & CORR BUT NOT LIMITED TO ORUDIS & ACTRON Control No: 98003412 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMA240 HFRSE240 HFZ82 Signature: P FURMAN Requester: OLSSON FRANK & WEEDA PC Subject: COMTRAD INDUSTRIES INC - CO RESPONSE TO WARNING LTR 11/6/97; CRYSTAL CARE INT'L CO RESPONSE TO WARNING LTR 12/30/96 Control No: 98003413 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Z TOMER Requester: UNIPHARM LTD Subject: SUMATRIPTAN SUCCINATE - SBA, RVWS Control No: 98003414 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: IBUPROFEN - BUT NOT LIMITED TO MEDIPREN, MOTRIN, ADVIL, ETC ADRS Control No: 98003415 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMW340 Signature: J EAKMAN Requester: ST ALEXIUS MEDICAL CENTER Subject: ST ALEXIUS MEDICAL CENTER, BISMARCK, ND - EIR 12/96 Control No: 98003416 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: INFORMATION ACCESS Subject: SCHERING - NASONEX NDA 20-762 SBA, APRVL LTR, LBLG, PI, ETC 1997 Control No: 98003417 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFA305 Signature: T SCHMIDT Requester: GUILFORD PHARMACEUTICALS INC Subject: A/C ONCOLOGIC DRUGS - TRANS 12/18/97 Control No: 98003418 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFIGC Signature: B ALMOND Requester: DEPARTMENT OF DEFENSE Subject: OVARIAN CANCER - PUBLICATIONS Control No: 98003419 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRSW240 Signature: G BERGT Requester: PENNFIELD ANIMAL HEALTH Subject: I D RUSSELL CO, LONGMONT, CO - EIR, 483 Control No: 98003420 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFA305 Signature: G BERGT Requester: PENNFIELD ANIMAL HEALTH Subject: I D RUSSELL, LONGMONT, CO - LINCOMYCIN HYDROCHLORIDE SOLUBLE POWDER ANADA 200-189 SBA Control No: 98003421 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 HFIGC Signature: M CHEN Requester: PRO-QU SOLUTIONS INC Subject: CPGM; INSTITUTIONAL REVIEW BOARDS & CLINICAL INVESTIGATORS Control No: 98003422 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: SHANNON T Subject: GENTOMYCIN; VANCOMYCIN - SBA, ADR, APRVL RECS, ETC Control No: 98003423 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: R OMAR Requester: CENTRE HOSPITALIER UNIVERSITAIRE Subject: POLOXAMER 407/BLOCK SOPOLYMER - RECS Control No: 98003424 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: STEIFEL - CLOBETASOL PROPIONATE TOPICAL GEL ANDA 75-027 SBA Control No: 98003425 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: J BISI Requester: ALPHARMA Subject: BAUSCH & LOMB - TRIMETHOPRIM SULFATE & POLYMYXIN B SULFATE ANDA 64-120 SBA Control No: 98003426 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: J FLAHERTY Requester: CONGDON FLAHERTY O'CALLAGHAN ET Subject: SIAM SEMPERMED CORP LTD - LATEX GLOVES ADR, MEMOS, STUDIES, ETC Control No: 98003427 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRMW140 HFRNE140 HFRNE240 HFS22 Signature: P KLEIN Requester: ABC NEWS Subject: FANCY CUTT FARMS - HEALTH & FOOD SAFETY VIOLATIONS RE E COLI OUTBREAKS Control No: 98003428 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C LEE Requester: FDC REPORTS INC Subject: PREMPRO - NDA 20-527/S006 RVWS Control No: 98003429 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C LEE Requester: FDC REPORTS INC Subject: PHOTOFRIN - NDA 20-541/S002 RVWS Control No: 98003430 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C LEE Requester: FDC REPORTS INC Subject: VANCOCIN - NDA 50-671/S002 RVWS Control No: 98003431 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C LEE Requester: FDC REPORTS INC Subject: TASMAR - NDA 20-697 RVWS Control No: 98003432 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C LEE Requester: FDC REPORTS INC Subject: BIOVAIL - TIAZAC RVW Control No: 98003433 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: C LEE Requester: FDC REPORTS INC Subject: BRISTOL-MYERS SQUIBB - MAXIPIME RVWS Control No: 98003434 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFZ82 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: A/C GENERAL & PLASTIC SURGERY DEVICES - MINS OF MTG 1/29-30/98 Control No: 98003435 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: A HUGUES Requester: MCKENNA & CUNEO LLP Subject: A/C DERMATOLOGIC & OPHTHALMIC DRUGS - MINS OF MTG 7/14-15/97 Control No: 98003436 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFIDR Signature: D BENNETT Requester: RHODES COATS & BENNETT Subject: PRENTKE ROMICH - HECS ENVIRONMENTAL CONTROL SYSTEM K902664 Control No: 98003437 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: DROUIN M Subject: DEPO-PROVERA - ADR Control No: 98003438 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: R OMEON Requester: WASHINGTON UNIVERSITY Subject: VICOPROFEN - ADR Control No: 98003439 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: J KENNEY Requester: BRISTOL MYERS SQUIBB Subject: NOVO NORDISK PHARMACEUTICALS - PRENDIN/REPAGLINIDE NDA 20-741 CORR, APRVL, RVWS, ETC Control No: 98003440 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFRNE240 Signature: R JONES Requester: RICH-SEAPAK CORP Subject: OVEN POPPERS INC, MANCHESTER, NH - EIR, 483, REG LTRS, ETC 1992-PRESENT Control No: 98003441 Received Date: 02/04/98 Due Date: 03/05/98 Action Offices: HFD205 Signature: Requester: GATTI C Subject: VISTARIL/HYDROXYZINE - ADR Control No: 98003442 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACHEMIE USA - CISPLATIN 1MG/ML INJ/ANDA 74-656 APRVL RECS Control No: 98003443 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACHEMIE BV - TAMOXIFEN CITRATE USP 10MG TABS/ANDA 74-539 APRVL RECS Control No: 98003444 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACHEMIE BV - LEUCOVORIN CALCIUM USP 25MG TABS/ANDA 73-101 APRVL RECS Control No: 98003445 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACHEMIE BV - LEUCOVORIN CALCIUM 50MG INJ/ANDA 89-628 APRVL RECS Control No: 98003446 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GENEVA PHARM - TERAZOSIN HCL 1, 2, 5 & 10MG TABS/ANDA 74-315 APRVL LTR, RVWS Control No: 98003447 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GENEVA PHARM - RANITIDINE USP 150 & 300MG TABS/ANDA 74-467 APRVL LTR, RVWS Control No: 98003448 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GC HANFORD MFG - STERILE CEFUROXIME SODIUM USP 750MG & 1.5G/AADA 64-125 APRVL LTR, RVWS Control No: 98003449 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GC HANFORD MFG - STERILE CEFUROXIME SODIUM USP 7.5G/AADA 64-124 APRVL LTR, RVWS Control No: 98003450 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FUJISAWA - IOPAMIDOL USP 51%, 61% & 76% INJ/ANDA 74-679 APRVL LTR, RVWS Control No: 98003451 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACHEMIE BV - LEUCOVORIN CALCIUM 100MG BASE INJ/ANDA 89-915 APRVL RECS Control No: 98003452 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: MONITORED ADR TRACKING RPT 1/98 Control No: 98003453 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PIERRE FABRE MEDICAMENT - ETOPOSIDE 20MG/ML INJ/ANDA 74-813 APRVL RECS Control No: 98003454 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GENSIA PHARM - ATRACURIUM BESYLATE 40MG/ML INJ/N74-784 SBA, APRVL LTR, LABELING ETC Control No: 98003455 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GENSIA PHARM - DILTIAZEM HCL 5MG/ML INJ/N74-894 SBA, APRVL LTR, LABELING ETC Control No: 98003456 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GENSIA PHARM - BUMETANIDE USP .25MG/ML INJ/N74-613 SBA, APRVL LTR, LABELING ETC Control No: 98003457 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GENSIA PHARM - VECURONIUM BROMIDE 10MG INJ/N74-688 SBA, APRVL LTR, LABELING ETC Control No: 98003458 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GENSIA PHARM - ACYCLOVIR SODIUM 500MG BASE & 1G BASE INJ/N74-969 SBA, APRVL LTR,LABELING ETC Control No: 98003459 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: GENSIA - LEUCOVORIN CALCIUM 350MG BASE INJ/N40-174 SBA, APRVL LTR, LABELING ETC Control No: 98003460 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACEUTICAL ASSOCS - CIMETIDINE HCL 300MG/5ML BASE SOL/ANDA 74-553 APRVL RECS Control No: 98003461 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PHARMACEUTICAL ASSOCS - THIORIDAZINE HCL USP 30MG/ML SOL/ANDA 40-187 APRVL RECS Control No: 98003462 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FUJISAWA - CISPLATIN 1MG/ML INJ/ANDA 74-735 APRVL LTR, RVWS Control No: 98003463 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FAULDING - ATRACURIUM BESYLATE 10MG/ML INJ/ANDA 74-741 APRVL LTR, RVWS Control No: 98003464 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PAR PHARMACEUTICAL - STERILE BACITRACIN USP/AADA 64-153 APRVL RECS Control No: 98003465 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FAULDING - ACYCLOVIR SODIUM 25MG/ML BASE INJ/ANDA 74-720 APRVL LTR, RVWS Control No: 98003466 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: OHMEDA - ATRACURIUM BESYLATE 10MG/ML INJ/ANDA 74-753 APRVL RECS Control No: 98003467 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: FAULDING - ATRACURIUM BESYLATE 10MG/ML INJ/ANDA 74-740 APRVL LTR, RVWS Control No: 98003468 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: OHMEDA - ATRACURIUM BESYLATE 10MG/ML INJ/ANDA 74-768 APRVL RECS Control No: 98003469 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: NOVOPHARM LTD - NAPROXEN SODIUM USP 220MG TABS/ANDA 74-635 APRVL RECS Control No: 98003470 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: HI-TECH PHARMACAL - CIMETIDINE HCL 300MG SOL/N74-664 SBA, APRVL LTR, LABELING ETC Control No: 98003471 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: MCKENZIE J Subject: FOOD SAFETY Control No: 98003472 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: HORN S Subject: FOOD SAFETY Control No: 98003473 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: MEYER J Subject: FOOD SAFETY Control No: 98003474 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: COLE C Subject: MEDICATION IMPORT Control No: 98003475 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: HOLSER R Subject: MEDICATION IMPORT Control No: 98003476 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: TENT R Subject: MEDICATION IMPORT Control No: 98003477 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: BOBBEY D Subject: MEDICATION IMPORT Control No: 98003478 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: BOBBEY S Subject: MEDICATION IMPORT Control No: 98003479 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: MODEIROS D Subject: MEDICATION IMPORT Control No: 98003480 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: STEWART J Subject: MEDICATION IMPORT Control No: 98003481 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: LINKE M Subject: MEDICATION IMPORT Control No: 98003482 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: GROVE A Subject: MEDICATION IMPORT Control No: 98003483 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: BIRSUL N Subject: MEDICATION IMPORT Control No: 98003484 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI30 Signature: Requester: HAYDEN C Subject: MEDICATION IMPORT Control No: 98003485 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFM48 Signature: C LEE Requester: FDC REPORTS INC Subject: GENZYME - CARTICEL RVW DOCS Control No: 98003486 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFM48 Signature: C LEE Requester: FDC REPORTS INC Subject: GENETICS INSTITUTE/AHP - BENEFIX - RVW DOCS Control No: 98003487 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: C LEE Requester: FDC REPORTS INC Subject: QLT - PHOTOFRIN RVW DOCS Control No: 98003488 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFM48 Signature: C LEE Requester: FDC REPORTS INC Subject: ROCHE/PDL - ZENAPAX RVW DOCS Control No: 98003489 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFM48 Signature: C LEE Requester: FDC REPORTS INC Subject: JOHNSON & JOHNSON/CHIRON - REGRANEX RVW DOCS Control No: 98003490 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI35 Signature: S SCHREIDERMAN Requester: FDC REPORTS INC Subject: WYETH-AYERT LABS - WARNING LTR 1/16/98 Control No: 98003491 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI35 Signature: S SCHNEIDERMAN Requester: FDC REPORTS INC Subject: CONVACARE SERVICE - WARNING LTR 12/18/92 Control No: 98003492 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFI35 Signature: S SCHREIDERMAN Requester: FDC REPORTS INC Subject: HOFFMAN LAROCHE - WARNING LTR 1/5/98 Control No: 98003493 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFIDR Signature: Requester: HU D Subject: ASHTONMEDICAL PRODUCTS INC - SURGICAL MASK/DENTAL MASK K895077 RECS Control No: 98003494 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFIDR Signature: Requester: HU D Subject: TECNOL NEW JERSEY WOUND CARE INC - FLUIDSHIELD K911891 Control No: 98003495 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFIDR Signature: Requester: HU D Subject: CLINICAL RESOURCES INC - GAUZE SPONGES K944879 Control No: 98003496 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFIDR Signature: Requester: HU D Subject: BAM CORP LTD - DISPOSABLE SURGICAL MASK K931580 Control No: 98003497 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: A WITKO Requester: HUNTLEIGH HEALTHCARE Subject: DANTEC MEDICAL INC - MULTI-DOP S K926363 Control No: 98003498 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: A WITKO Requester: HUNTLEIGH HEALTHCARE Subject: HILL-ROM CO INC - DYNAMICAIRE SLEEP SURFACE ZONEAIR SLEEP SURFACE K945729 Control No: 98003499 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: P PERL Requester: MEDITRONICS CORP Subject: OPGAL OPTRONIC INDUSTRIES - INTRAOPERATIVE VASCULAR ANGIOGRAPHY K951806 Control No: 98003500 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: L GILBERT Requester: ALCON LABORATORIES INC Subject: EYESIS TECHNOLOGIES INC - EYE SYS VISTA K973756 Control No: 98003501 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFIDR Signature: C BELL Requester: JOHNSON & JOHNSON MEDICAL INC Subject: MONARCH PRODUCTS INC - BEMIS STERILE CASE K885019 Control No: 98003502 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: C BELL Requester: JOHNSON & JOHNSON MEDICAL INC Subject: MONARCH PRODUCTS INC - STERILIZATION CONTAINER SYSTEM K911760 Control No: 98003503 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: C BELL Requester: JOHNSON & JOHNSON MEDICAL INC Subject: MONARCH PRODUCTS INC - STERILATION CONTAINER K852335 Control No: 98003504 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: ADMINISTRATOR Requester: RESPONSE Subject: HUMAN PAPILLOMA VIRUS DNA TYPING KIT - PMA P890064/SOO5 Control No: 98003505 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFIDR Signature: Requester: FOI SERVICES INC Subject: OLYMPUS - OLYMPUS GF-UM3/EU-M3 K882061 Control No: 98003506 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: CONTACT LATEX DIPPERS, MALAYSIA - EIR & 483 1/1/95 TO 1/31/98 Control No: 98003507 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: A/C CARDIOVASCULAR & RENAL DRUGS MTG - MINUTES 6/26/97 Control No: 98003508 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFZ82 Signature: R JONES Requester: MERCY HOSPITAL MEDICAL CENTER Subject: PILLING WECK INC - WECK HEMOCLIP LITIGATING CLIPS MEDWATCH RPT Control No: 98003509 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRNE140 HFRP240 Signature: Requester: D'LACEY B Subject: CLAIROL INC, NEW YORK, NY & DUART LABS, CAMARILLO, CA - CMPLNTS & EIRS Control No: 98003510 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRNE140 Signature: P MITCHELL Requester: OKLAHOMA BLOOD INTITUTE Subject: CTM INDUSTRIES, QUEENS VILLAGE, NY - FDA REGISTRATION 2475932 Control No: 98003511 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRP140 Signature: D LANKER Requester: ALLERGAN INC Subject: CAMPBELL, CA - EIR & QAP 10/13-20/97 Control No: 98003512 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRSW140 Signature: Requester: FOI SERVICES INC Subject: ISP, TEXAS CITY, TX - EIR, 483 & CO RESPONSE MOST RECENT Control No: 98003513 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRMA240 Signature: Requester: FOI SERVICES INC Subject: AQUALON, HOPEWELL, VA - EIR, 483 & CO RESPONSE MOST RECENT Control No: 98003514 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRMA440 Signature: Requester: FOI SERVICES INC Subject: BENVENUE LABS, BEDFORD, OH - CO RESPONSE TO 483 8/18-22/97 Control No: 98003515 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRMA440 Signature: Requester: FOI SERVICES INC Subject: BENVENUE LABS, BEDFORD, OH - EIR, 483 & CO RESPONSE 9/97 TO DATE Control No: 98003516 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRSW240 Signature: Requester: FOI SERVICES INC Subject: PHARMACIA & UPJOHN, ALBUQUERQUE, NM - EIR 2 MOST RECENTS Control No: 98003517 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFRMW240 Signature: Requester: FOI SERVICES INC Subject: PERRIGO CO, MONTAGUE, MI - EIR, 483 & CO RESPONSE 5-7/97 Control No: 98003518 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFC230 Signature: WESLEY Requester: STELEX INC Subject: SOMPUTER SYSTEMS VALIDATION INV Control No: 98003519 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFS22 Signature: J COHEN Requester: KELLER & HECKMAN LLP Subject: DSHEA-MANDATED 30-DAY NOTIFICATIONS Control No: 98003520 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: J MORGAN Requester: REGULATORY AFFAIRS NORTH AMERICA Subject: INPLEMENTATION OF EMERGENCY RESEARCH INFOMED CONSENT WAIVER RULE MTG - TRANS 9/29-30/97 Control No: 98003521 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: D MCDUFFIE Requester: BRISTOL MYERS SQUIBB Subject: A/C CARDIOVASCULAR & RENAL DRUGS MTG - TRANS 1/27&27/98 Control No: 98003522 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFM48 HFRMA340 Signature: Requester: FOI SERVICES INC Subject: ORTHO BIOTECH, RARITAN, NJ - EIR 8/25-29/97 Control No: 98003523 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: VIRAGEN - ALPHA-LEUKOFERON SBA, APRVL LTR, LBLG, ETC Control No: 98003524 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFM48 Signature: Requester: FOI SERVICES INC Subject: SMITHKLINE BEECHAM BIOLOGICAL, BELGIUM - EIR & 483 8/25-9/4/97 Control No: 98003525 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: I HERMAN Requester: INTERWORLD COMMODITIES INC Subject: A/C CARDIOVASCULAR & RENAL DRUG MTG - TRANS 1/28/98 Control No: 98003526 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: G KOBRIN Requester: PHARMACIA & UPJOHN Subject: DKT P96-0036 Control No: 98003527 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: Requester: FOI SERVICES INC Subject: DKT 92N-0434 Control No: 98003528 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: DEBTOR Signature: S MCMANIGAL Requester: CREIGHTON UNIVERSITY Subject: INTRAVASCULAR HEMOLYTIC TRANSFUSION - ABO TRANSFUSION REACTION Control No: 98003529 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: I BLANCH Requester: LABORATORIOS DR ESTEVE Subject: ELI LILLY & CO - ZYPREXA/OLANZAPINE TOXICOLOGICAL EVALUATION Control No: 98003530 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: D HASELEY Requester: INSIDE WASHINGTON PUBLISHERS Subject: DKT 97D-0261 VOL 1 NAD 2, 98D-0007 VOL 1 NAD 1, ETC Control No: 98003531 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: A WRIGHT Requester: FOOD CHEMICAL NEWS Subject: DKT 97N-0296 C74 & C75, 97N-0217 C93-C95, ETC Control No: 98003532 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: C PAPPAS Requester: BYRON CHEMICAL COMPANY INC Subject: SHANGHAI #6 PHARM FACTORY, CHINA - EIR, 483 Control No: 98003533 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: A WRIGHT Requester: FOOD CHEMICAL NEWS Subject: DKT 93E-0213, 76N-0361, 77N-0313 Control No: 98003534 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: J MCKENNA Requester: FDC REPORTS INC Subject: DKT 77N-094W C11, C9, C1 Control No: 98003535 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: R CHEN Requester: INDIVIDUAL INVESTOR MAGAZINE Subject: LIST OF APPROVED DRUGS TO TREAT POST-SURGERY INFECTIONS FROM GASTROINTESTINAL SURGERIES Control No: 98003536 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: A MATHER Requester: PATTON BOGGS LLP Subject: DKT 85N-0061 VOL 75, REF 23, PGS 382-470 Control No: 98003537 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: V DOANE Requester: PARKE DAVIS Subject: LIST OF CLINICAL INVESTIGATORS INSPECTED 11//77 TO PRESENT Control No: 98003538 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 95N-0214 C9, C22, C32 Control No: 98003539 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: E MCKENNA Requester: FDC REPORTS INC Subject: DKT 78N-0038 VOL 111 C542, 97P-0441 VOL 8 C140, ETC Control No: 98003540 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: V DOANE Requester: PARKE DAVIS Subject: LIST OF FILES CLOSED FOR BOTH "ROUTINE" AND "FOR CAUSE" CLINICAL INVESTIGATOR INSPECTIONS 6/1/77 TO PRESENT Control No: 98003541 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: V DOANE Requester: PARKE DAVIS Subject: IRAVANI A, ORLANDO, FL - EIR, 483, CORR ETC 8/95 Control No: 98003542 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: A/C PSYCHOPHARMACOLOGIC DRUGS - TRANS 12/4/97, A/C BLOOD PRODS - TRANS 12/11/97 Control No: 98003543 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: W WALKER Requester: DAILY NEWS Subject: FEN-PHEN - ADRS Control No: 98003544 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: OTC VOL 040298: MEMO TO DR GUTHRIE Control No: 98003545 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: DKT 97N-0517 APE1, 97N-0325 C59-C63, 90P-0247 PAV1 SUP1 CP1, ETC Control No: 98003546 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: M BECKER Requester: BUC & BEARDSLEY Subject: DKT 81N-0033 VOL 29 LET29 & LET30, C41, ETC Control No: 98003547 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: A MATHER Requester: PATTON BOGGS LLP Subject: DKT 91N-100H VOL 9A REF 54, 94P-0036 VOL 1 CP1 Control No: 98003548 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: DKT 78N-0038 C542, 84N-0102 LST Control No: 98003549 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: DKT 98H-0030 LET1 NPH1, 98H-0025 LET1 NPH1, ETC Control No: 98003550 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: C CELESTE Requester: AAC CONSULTING GROUP INC Subject: DKT 77N-094W VOL 2 C12, VOL 3 C13 Control No: 98003551 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: DKT 78N-0038 VOL 111 C542, 97P-0429 VOL 1 PAV1, EATC Control No: 98003552 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: M BECKER Requester: BUC & BEARDSLEY Subject: DKT 79N-0182 89P-0164 Control No: 98003553 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: L REDINGTON Requester: LYNN REDINGTON & ASSOCS Subject: LIST OF IN VITRO DIAGNOSTIC TEST KITS CLEARED FOR MARKETING USING IMMUNOASSAY TECHNIQUES TO SCREEN AND/OR MONITOR CANCER Control No: 98003554 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: DKT 97S-0162 LET815-C930, 92P-0481 PDN1 CP, ETC Control No: 98003555 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: P GARGANI Requester: ERREGIERRE INDUSTRIA CHIMICA SPA Subject: ERREGIERRE, ITALY - EIR 10/20-22/97 Control No: 98003556 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFICD Signature: L ZIMMERMAN Requester: MDS HARRIS LABORATORIES Subject: DEBARMENT LIST MOST RECENT Control No: 98003557 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: G OEHLERT Requester: HOGAN & HARTSON Subject: DKT 95N-0228 VOL 1 CH1 APE2, VOL 3 CH7 TS1, ETC Control No: 98003558 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: A LIEU Requester: SIGMA COMPANY LTD Subject: PURDUE FREDERICK - BETADINE 5% OPHTHALMIC SOL RECS Control No: 98003559 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: M PALMER Requester: PAUL HASTINGS JANOFSKY & WALKER Subject: DKT 77N-0094W C13 Control No: 98003560 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: E GOODMAN Requester: ARNOLD & PORTER Subject: DKT 96P-0316 LET1, 97A-0534 CP1, 98P-0059 CP1 Control No: 98003561 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: J WEINER Requester: PIPER & MARBURY Subject: DKT 97P-0441 VOL 8 C115 & C138, VOL 1, VOL 4 LET2 & LET3, C1 Control No: 98003562 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: H ECKER Requester: AIDS/STD NEW REPORT Subject: DKT 97N-0165 D C12, C9, E C6, MM1, C1, ETC Control No: 98003563 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: M PALMER Requester: PAUL HASTINGS JANOFSKY & WALKER Subject: DKT 77N-094W Control No: 98003564 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: C AGNOLUTTO Requester: KING & SPALDING Subject: MERRELL DOW - IRON DEXTRAN SBA, APRVL LTR, LABELING ETC Control No: 98003565 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: G OEHLERT Requester: HOGAN & HARTSON Subject: DKT 76N-052G VOL 2 LET97, CHRON LIST OF PETITIONS Control No: 98003566 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: J DICKINSON Requester: FERDIC INC Subject: DKT 97P-0156 PDN1, 97P-0429 PAV1, ETC Control No: 98003567 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFD205 Signature: Requester: POLYAKOV V Subject: LIST OF PHARMACEUTICAL CO'S REGISTERED W/FDA Control No: 98003568 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: H ECKER Requester: AIDS/STD NEW REPORT Subject: DKT 97N-0165 C55 PGS 1-3, B1-B3, ANS1, EXT1, C53, ETC Control No: 98003569 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: J WEINER Requester: PIPER & MARBURY Subject: DKT 97S-0163 VOL 1 LET60-LET75, VOL 2 Control No: 98003570 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: P SMALL Requester: FOI SERVICES INC Subject: DKT 96P-0354 Control No: 98003571 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: DKT 97P-0156 VOL 1 PDN1, 98P0-0059 VOL 1 CP1 Control No: 98003572 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: Z STEELE Requester: STEELE COMMUNICATIONS Subject: DKT 92N-0139 VOL 71 C4520 & C4518, 97N-0296 VOL 2 C74, ETC Control No: 98003573 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: K MOSS Requester: ARENT FOX KINTNER PLOTKIN & KAHN Subject: DKT 95S-0117 VOL 2 LST23 Control No: 98003574 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: K SMEDLEY Requester: CENTER FOR REGULATORY SERVICES Subject: DKT 97S-0162 LET814-LET930 Control No: 98003575 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: P MUCHA Requester: FOX BENNETT & TURNER Subject: DKT 97P-0441 Control No: 98003576 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: S BUTCHOCK Requester: MEDICAL DEVICE REPORT Subject: DKT 97N-0385 NAL1, 95N-0176 Control No: 98003577 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: W OLSON Requester: CENTER FOR REGULATORY SERVICES Subject: DKT 94F-0283 Control No: 98003578 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: A LAVENDER Requester: LAVENDER CONSULTING SERVICES Subject: DKT 97N-0199 C13 Control No: 98003579 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: K SMITH Requester: SEC INFOLINE Subject: DKT 95P-0197 Control No: 98003580 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: B SCHOCHET Requester: OLSSON FRANK & WEEDA PC Subject: DKT 95S-0117 VOL 2 LET34, 97N-0217 C91-C102, ETC Control No: 98003581 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: DKT 92P-0441 VOL 8 C55, C33, C37, EXT4, EXT3, C47, ETC Control No: 98003582 Received Date: 02/05/98 Due Date: 03/06/98 Action Offices: HFA305 Signature: Requester: DENNISTON Subject: DKT 96N-0420 & 92N-454A INDEX Control No: 98003583 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: Requester: RESPONSE Subject: ONCOLOGIC DRUGS A/C MTG - TRANS 12/18-19/97 Control No: 98003584 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: Requester: RESPONSE Subject: VACCINE & RELATED BIOLOGICAL PRODS A/C MTG - TRANS 12/11-12/97 Control No: 98003585 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: RESPONSE Subject: 97-41355 REQUEST & RESPONSE LTR Control No: 98003586 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: RESPONSE Subject: 97-295 REQUEST & RESPONSE LTR Control No: 98003587 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRP140 Signature: Requester: FOI SERVICES INC Subject: SIERRA BIOMEDICAL INC, SPARKS, NV - EIR, 483 MOST RECENT Control No: 98003588 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-3026 Control No: 98003589 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-2907 Control No: 98003590 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-2539 Control No: 98003591 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: CONTOUR ELECTRODE - K844345 Control No: 98003592 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: RESPONSE Subject: 97-422 REQUEST & RESPONSE LTR Control No: 98003593 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 HFRNE240 Signature: J HARTTEN Requester: AKIN GUMP STRAUSS HAUER & FELD Subject: BRYAN CORP, WOBURN, MA - STERILE AEROSOL TALC SPRAY RECALL 7/94 Control No: 98003594 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: COLLIER SHANNON RILL & SCOTT Subject: WARNING LTRS WEEK OF 2/3/98 Control No: 98003595 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: S SETON Requester: ALRA LABORATORIES INC Subject: INCREDIBLE PRODS INC, AKRON, OH - WARNING LTR 1/9/98; HOFFMANN-LAROCHE INC, NUT-LEY, NJ - WARNING LTR 1/5/98; WYETH-AYERST LABS, PHILADELPHIA, PA - WARNING LTR 1/16/98 & 4 OTHER WARNING LTRS Control No: 98003596 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 HFRSE440 Signature: T HARRIS Requester: COWLES & THOMPSON Subject: GIBSON G - CMPLNTS, INVESTIGATION RECS ETC Control No: 98003597 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 HFD205 Signature: S PAPE Requester: PURDUE PHARMA L P Subject: CARDIO RENAL A/C MTG - TRANS OR SUMMARIES 1/26-27/98 Control No: 98003598 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: P SELLERS Requester: JOHN D HYNES & ASSOCIATES INC Subject: ROBERTSON H - RECS Control No: 98003599 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: L BORK Requester: NYCOMED DAK A/S Subject: LIST OF INVESTIGATORS INELIGIBLE TO RECEIVE INVESTIGATIONAL NEW DRUGS Control No: 98003600 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: J HAUSHEER Requester: STERI-OSS INC Subject: IMPLANT INNOVATIONS INC - 3I BIORESORBABLE FIXATION TACK/K972480 510K; IMTEC CORP - IMTEC BONE TAC/K973180 510K Control No: 98003601 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFIGC Signature: R BYRNES Requester: WALLACE LABORATORIES Subject: LIST OF CURRENT COMPOUNDS RECEIVING ORPHAN-DRUG DESIGNATION Control No: 98003602 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFIMO Signature: W MORRIS Requester: FDC REPORTS INC Subject: GEDEON - WARNING LTR 9/5/97; NIPPON KAYAKU - WARNING LTR 5/23/97; BIDUCHEM - WARNING LTR 11/18/96 Control No: 98003603 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: J FINK Requester: UNIVERSITY OF KENTUCKY Subject: "DRAFT GUIDANCE FOR INDUSTRY: PROMOTING MEDICAL PRODS IN A CHANGING HEALTHCARE ENVIRONMENT" Control No: 98003604 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMA140 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: CENTEON - WARNING LTR PRIOR TO 1/97 Control No: 98003605 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFC230 Signature: M NAPPI Requester: LACHMAN CONSULTANT SERVICES INC Subject: BAXTER HEALTHCARE CORP - COMPASS PROGRAM LTR 1995 OR 1996 Control No: 98003606 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: S MCPHERSON Requester: TROY A TITUS PC Subject: PREMARIN VAGINAL CREAM - MANUFACTURER NAME, ADDRESS, & TELEPHONE NUMBER Control No: 98003607 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: C BEHRAVESH Requester: ASCENT PEDIATRICS INC Subject: PREDNISOLONE ORAL SYRUP - SBA, PHARMACOKINETICS RVW, CHEMISTRY RVW, ETC Control No: 98003608 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRP240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: THERAPEUTIC CORP, LOS ANGELOS, CA - WARNING LTRS 1/97 TO DATE Control No: 98003609 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: D PEDERSEN Requester: HOLY CROSS HOSPITAL Subject: AT-HOME TERBUTALINE PUMPS - 954-492-5763 Control No: 98003610 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: M JOHNSON Requester: AKIN GUMP STRAUSS HAUER & FELD Subject: BRYAN CORP & NOVATECH - STERILE TALC CORR 1/94 TO PRESENT Control No: 98003611 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFS22 Signature: M FIUME Requester: COSMETIC INGREDIENT REVIEW Subject: WILD YAM EXTRACT & YARROW EXTRACT - TOXICOLOGICAL DATA Control No: 98003612 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFY12 Signature: S SEXTON Requester: ALRA LABS INC Subject: LTR FR/ NIGHTINGALE S TO MEDICAL PROFESSIONAL ASSOCS & MAJOR PATIENT GROUPS Control No: 98003613 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: J KISTLER Requester: GLAXO WELLCOME Subject: SCHWARTZ R H, VIENNA, VA - EIRS, 483S, WARNING LTRS, ETC 1994 TO 1998 Control No: 98003614 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: ADMINISTRATOR Requester: RESPONSE Subject: LIST OF EIRS CONDUCTED UNDER GOOD CLINICAL PRACTICES 5/97 TO PRESENT Control No: 98003615 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: ADMINISTRATOR Requester: RESPONSE Subject: A/C - CIRCULATORY SYSTEMS DEVICES PANEL OF THE MEDICAL DEVICES TRANS 12/4/97 Control No: 98003616 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-41050 REQUEST LTR & RESP LTR ONLY Control No: 98003617 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-350 REQUEST LTR & RESP LTR ONLY Control No: 98003618 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMA240 Signature: Requester: FOI SERVICES INC Subject: MIDATLANTIC BIO-RESEARCH COR, TEMPLE HILLS, MD - EIR & 483 MOST RECENT Control No: 98003619 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMA140 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: CENTEON, KING OF PRUSSIA, PA - WARNING LTRS 1/97 TO PRESENT Control No: 98003620 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMW240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: IMMUNO-US. ROCHESTER, MI - WARNING LTRS PRIOR TO 1/97 Control No: 98003621 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRP240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: BAXTER HEALTHCARE CORP, GLENDALE, CA - WARNING LTRS 1/97 TO PRESENT Control No: 98003622 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRSE240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: NORTH AMERICAN BIOLOGICALS INC, MIAMI, FL - WARNING LTRS PRIOR TO 1/97 Control No: 98003623 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRNE240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: BAYER CORP, W HAVEN, CT - WARNING LTRS PRIOR TO 1/97 Control No: 98003624 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMW240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: IMMUNO-US INC, ROCHESTER, MI - WARNING LTRS 1/97 TO PRESENT Control No: 98003625 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRNE140 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: BAXTER HEALTHCARE CORP, GLENDALE, CA - WARNING LTRS PRIOR TO 1/97 Control No: 98003626 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRNE240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: BAYER CORP, W HAVEN, CT - WARNING LTRS 1/97 TO PRESENT Control No: 98003627 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFM48 Signature: A TSIEN Requester: OLSSON FRANK & WEEDA PC Subject: WYETH-LEDERLE - CORR 1/97 TO PRESENT Control No: 98003628 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFM48 Signature: A TSIEN Requester: OLSSON FRANK & WEEDA PC Subject: SMITHKLINE BEECHAM - CORR 7/1/97 TO PRESENT Control No: 98003629 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFM48 Signature: A TSIEN Requester: OLSSON FRANK & WEEDA PC Subject: MERCK & CO - CORR 7/1/97 TO PRESENT Control No: 98003630 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFIGC Signature: Requester: STRIZICH J Subject: BOTOX INJ - APRVL RECS Control No: 98003631 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFS22 Signature: Requester: FOI SERVICES INC Subject: HUMAN MILK OLIGOSACCHARIDES - RECS Control No: 98003632 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-2882 Control No: 98003633 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFIMO Signature: G OEHLERT Requester: HOGAN & HARTSON Subject: WARNING LTRS 2/3/98; IMPORT ALERTS 1/26/98 Control No: 98003634 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: K912521 DENTAL IMPLANT SYSTEM 4.0MM & 5.5MM 510K Control No: 98003635 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: R WHITE Requester: SURGICAL NAVIGATION TECHNOLOGIES Subject: RADIONICS - GILL-THOMAS-COSMAN RELOCATABLE HEAD HOLDER/K934523 510K Control No: 98003636 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: C GODIN Requester: SCHWARZ PHARMA INC Subject: BEDFORD LABS - ALPROSTADIL INJ SBA Control No: 98003637 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-2243 Control No: 98003638 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: E SMITH Requester: MERCK GENERICS Subject: PROCHLORPERAZINE - ANALYSIS Control No: 98003639 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: S YANG Requester: UNICARE BIOMIEDICAL Subject: U.S. BIOMATERIALS - K962494 510K; ORTHOVITA CO - K952922 510K Control No: 98003640 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: SANTIAGO H Subject: FASTIN/NAC - CMPLNTS Control No: 98003641 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFIGC Signature: S KOMANESKY Requester: MERCK & CO INC Subject: CUMULATIVE LIST OF DESIGNATED ORPHAN DRUGS & BIOLOGICS 12/31/97 Control No: 98003642 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: J ABILLA Requester: HDC CORP Subject: MEDTRONIC INC - METRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM/K965251 Control No: 98003643 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: J HAUSHEER Requester: STERI-OSS INC Subject: K910427 (MEMFIX SCREWS) Control No: 98003644 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: P STEGNER Requester: HOECHST MARION ROUSSEL INC Subject: GENEVA PHARM - HALOPERIDOL SBA, APRVL LTR, RVWS ETC Control No: 98003645 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: S COLUMBUS Requester: INTERCHEM CORPORATION Subject: RANBAXY LABS, INDIA - EIRS, 483S, CO RESPS PAST 2 YRS Control No: 98003646 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 HFS22 Signature: L ANGELO Requester: SIGMA-TAU PHARMACEUTICALS INC Subject: CARNITINE, LEVO CARNITINE, EL CARNITINE & ACETYL CARNITINE - STATEMENTS FOR NUTRITIONAL SUPPORT Control No: 98003647 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: L CAHN Requester: ABBEY GARDY & SQUITIERI Subject: DKT# 97M-0274 & 97P-0441 Control No: 98003648 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: F MARX Requester: SQM IODINE CORPORATION Subject: CHEMICAL FORMULA FOR EACH DRUG CONTAINING IODINE Control No: 98003649 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFIGC Signature: Requester: HALL M Subject: CEREAL BOXES - SHOPPER'S RANDOM OR SCHEDULED TESTS INFO Control No: 98003650 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: S SEARS Requester: DDEAMC Subject: IRINOTECAN/CAMPTOSAR - ADRS, EPIDEMIOLOGIC/BIOGRAPHIC DATA Control No: 98003651 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: C JONES Requester: VERTEX PHARMACEUTICALS Subject: ONCOLOGIC DRUGS A/C - TRANS 9/11/96, 12/16/96, 12/18/97 & 12/19/97 Control No: 98003652 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: KUIPERS V Subject: HYDROCORTISONE CREAM - ADRS Control No: 98003653 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: S MCPHERSON Requester: TROY A TITUS PC Subject: PREMARIN VAGINAL CREAM - REGISTRATION RECS Control No: 98003654 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: F FERGUSON Requester: FERGUSON MEDICAL Subject: DKT 97M-0520 Control No: 98003655 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMA140 Signature: J FARRAR Requester: UNIVERSITY OF PENNSYLVANIA MEDICA Subject: UNIV OF PA, PHILADELPHIA, PA - EIR 11/11-12/97 Control No: 98003656 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFM48 Signature: Requester: GREENE R Subject: POISON IVY EXTRACTS - RECS Control No: 98003657 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-601 REQUEST/RESP LTR Control No: 98003658 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: DOE J Subject: PHENYLPROPANOLAMINE - ADRS Control No: 98003659 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 HFS22 Signature: M FIUME Requester: COSMETIC INGREDIENT REVIEW Subject: SALICYLIC ACID, BUTYLOCTYL SALICYLATE, CALCIUM SALICYLATE, ETC - TOXICOLOGICAL DATA Control No: 98003660 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: J KISTLER Requester: GLAXO WELLCOME Subject: SHAPIRO, SAN DIEGO, CA - EIRS, 483S, WARNING LTRS, ETC 1994-1998 Control No: 98003661 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: COLLATERAL THERAPEUTICS & CRYSTAL R - CORR Control No: 98003662 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 HFS22 Signature: M FIUME Requester: COSMETIC INGREDIENT REVIEW Subject: AMINO-M-CRESOL CAS NOS 2835-98-5, 17672-22-9 & 2835-99-6 - TOXICOLOGICAL DATA Control No: 98003663 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-42623 - REQUEST & RESPONSE LTRS Control No: 98003664 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-42169 - REQUEST & RESPONSE LTRS Control No: 98003665 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFIGC Signature: L SCHIFF Requester: GENZYME TRANSGENICS Subject: ORPHAN-DRUG & BIOLOGICAL DESIGNATIONS - CURRENT LIST Control No: 98003666 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: KISTLER J Requester: GLAXO WELLCOME Subject: IRAVANI, ORLANDO, FL - EIR, 483, WARNING LTRS, ETC Control No: 98003667 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: W ANDERSON Requester: VENABLE BAETJER HOWARD ET AL Subject: WARNING LTRS 2/3/98 Control No: 98003668 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: UPSHER-SMITH - POTASSIUM CHLORIDE SBA, APRVL LTR, LBLG, ETC Control No: 98003669 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: S BUTCHOCK Requester: MEDICAL DEVICE REPORT Subject: WARNING LTRS 2/3/98, K830517 Control No: 98003670 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: ADMINISTRATOR Requester: RESPONSE Subject: A/C ANTIVIRAL DRUGS MTG - TRANS 1/14/98 Control No: 98003671 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-40736 - RESPONSE & REQUEST LTRS Control No: 98003672 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: ADMINISTRATOR Requester: RESPONSE Subject: A/C PHARMACEUTICAL SCIENCE - TRANS 12/11-12/97 Control No: 98003673 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-42158 - REQUEST & RESPONSE LTRS Control No: 98003674 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: C THOMASON Requester: WORLDWIDE CLINICAL TRIALS INC Subject: HYDROCHLOROTHIAZID/MOEXIPRIL HYDROCHLORIDE (UNIRETIC) - SBA Control No: 98003675 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-42532 - REQUEST & RESPONSE LTRS Control No: 98003676 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 HFS22 Signature: Requester: BARHAM E Subject: VENASTAT - RECS Control No: 98003677 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRSW340 Signature: Requester: FOI SERVICES INC Subject: KANSAS CITY ANALYTICAL SERVICES, INC, SHAWNEE, KD - EIR & 483 1/97 TO DATE Control No: 98003678 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: J KISTLER Requester: GLAXO WELLCOME Subject: STAMM W, SEATTLE, WA - EIR, 483, WARNING LTR, CORR, CO RESPONSE 1994-1998, 3/17/97 Control No: 98003679 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: RESPONSE Subject: GLAXO - BECONASE AQ NASAL SPRAY APRVL LTR, PKG CIRC, RVWS NDA 19-389 Control No: 98003680 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: SYNTEX - TICLID CORR, WARNING LTRS, ETC Control No: 98003681 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-1680 Control No: 98003682 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-2244 Control No: 98003683 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: EDWARD T, ALBANY, NY - EIR & 483 10/97-11/97 Control No: 98003684 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-39900 REQUEST/RESP LTR Control No: 98003685 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-41687 REQUEST/RESP LTR Control No: 98003686 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-230 REQUEST/RESP LTR Control No: 98003687 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRSE540 Signature: Requester: FOI SERVICES INC Subject: PACO PUERTO RICO, CANOVANAS, PR - EIRS 11/1-7/95, 5/14/96 & 7/96 Control No: 98003688 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-3055 Control No: 98003689 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRNE140 Signature: R QUINE Requester: D&E PHARMACEUTICALS INC Subject: VITAMIN POWER, FREEPORT, NY - EIR, COVER SHEET, 483, ETC 1/1/85 TO DATE Control No: 98003690 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRNE240 Signature: Requester: FOI SERVICES INC Subject: STAMBLER B, WEST ROXBURY, MA - EIR, 483, CORR 3/27/95 Control No: 98003691 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: G EMELOCK Requester: CRO GROUP Subject: HEARTLAB INC, PROVIDENCE, RI - DIGITAL IMAGING RVW SYSTEM K954479 Control No: 98003692 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: PFIZER/ROERIG - UNASYN LBLG RECS Control No: 98003693 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: G ZAMBA Requester: BIOGENETIC TECHNOLOGIES INC Subject: TRIDENT SURGICAL CORP - K820664 Control No: 98003694 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: FOI SERVICES INC Subject: TAP PHARMS - LUPRON RESP LTR/MACMIS ID 5439 5/29/97 Control No: 98003695 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMA240 Signature: D GREEN Requester: PAUL HASTINGS JANOFSKY & WALKER Subject: AMVAX/N AMERICAN VACCINE - EIR, 483 MOST RECENT Control No: 98003696 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: F FERGUSON Requester: FERGUSON MEDICAL Subject: DKT 97M-0453 Control No: 98003697 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMA340 Signature: R QUINE Requester: D & E PHARMACEUTICALS INC Subject: VITAMIN SHOPPE, NORTH BERGEN, NJ - EIRS, 483S, REGULATORY ACTIONS 1/1/85-PRESENT Control No: 98003698 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRSE240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: NORTH AMERICAN BIOLOGICALS INC/NABI, MIAMI, FL - WARNING LTRS 1/97-PRESENT Control No: 98003699 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: J PADILLA Requester: SOLAR & FERNANDES Subject: ENDO PHARMACEUTICALS INC - NUBAIN DEAR DOCTOR OR DEAR PHARMACIST LTRS Control No: 98003700 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: S ATHERAY Requester: DUMEX MEDICAL SURGICAL PRODUCTS Subject: KENDALL HEALTHCARE PRODUCTS - CURITY PACKING STRIPS, CURASALT SODIUM CHLORIDE DRESSING 510K(S) Control No: 98003701 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: Requester: SHORT G Subject: SYNTHROID/THYROID PREPARATION - ADR PRINTOUT Control No: 98003702 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: E DELANEY Requester: AAC CONSULTING GROUP INC Subject: FOI LOG - 2/4/98 Control No: 98003703 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRP240 Signature: H TARLETON Requester: CHANDLER CHICCO AGENCY Subject: ALPHA THERAPEUTIC CORP, LOS ANGLES, CA - WARNING LTRS PRIOR TO 1/97 Control No: 98003704 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRSE240 Signature: R QUINE Requester: D & E PHARMACEUTICALS INC Subject: NATIONAL HEALTH PRODS, ORLANDO, FL - EIRS, 483S, REGULATORY ACTIONS 1/1/85- PRESENT Control No: 98003705 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 HFS22 Signature: M FIUME Requester: COSMETIC INGREDIENT REVIEW Subject: TOCOPHEROL; TOCOPHERSOLAN; TOCOPHERYL ACETATE; ETC - TOX DATA Control No: 98003706 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: E HOUSEMAN Requester: LIEVER HYMAN & POTTER Subject: LUMBAR EPIDURAL DEPO-MEDROL INJECTIONS - ADVERSE REACTIONS Control No: 98003707 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-42258 Control No: 98003708 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: G EMELOCK Requester: CRO GROUP Subject: KODAK DIGITAL SCIENCES, ROCHESTER, NY - CARDIAC REVIEW STATION K974086 Control No: 98003709 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: M BLUNK Requester: CENTEON Subject: INACTIVE INGREDIENT GUIDE Control No: 98003710 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: S SIMPSON Requester: AAC CONSULTING GROUP INC Subject: NDA 19-710; 18-905 Control No: 98003711 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFM48 Signature: Requester: NEUHART S Subject: SHERMAN OAKS COMMUNITY HOSPITAL, SHERMAN OAKS, CA - FORM 1572 Control No: 98003712 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: Requester: FOI SERVICES INC Subject: BIOSURGICAL - MULTI CHAMBER SUCTION SYRINGE K964597 Control No: 98003713 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 HFS22 Signature: M FIUME Requester: COSMETIC INGREDIENT REVIEW Subject: ARNICA MONTANA/EXTRACT; CALENDULA OFFICINALIS/EXTRACT; HYPERICUM PERFORATUM OIL/EXTRACT - TOXICOLOGY DATA Control No: 98003714 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-3029 Control No: 98003715 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI30 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-42224 REQUEST LTR & RESP LTR ONLY Control No: 98003716 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-2807 Control No: 98003717 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-2137 Control No: 98003718 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: J KIM Requester: BUC & BEARDSLEY Subject: WARNING LTRS & IMPORT ALERTS Control No: 98003719 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: D GREEN Requester: PAUL HASTINGS JANOFSKY & WALKER Subject: ROSENTHAL J - EIR & 483 Control No: 98003720 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: J KISTLER Requester: GLAXO WELLCOME Subject: MROCZKOWSKI, NEW ORLEANS, LA - EIR, 483, WARNING LTRS, CORR, ETC 1994-1998 Control No: 98003721 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: A HUGHES Requester: MCKENNA & CUNEO LLP Subject: WARNING LTRS 2/3/98 & IMPORT ALERTS 1/26/98 Control No: 98003722 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: ADMINISTRATOR Requester: RESPONSE Subject: SYNTEX - NASALIDE/FLUNISOLIDE NDA 20-409 APRVL LTR, PI, RVWS Control No: 98003723 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFIGC Signature: S SEXTON Requester: ALRA LABORATORIES INC Subject: 1/30/98 FEDERAL REGISTER NOTICE FINAL RULE Control No: 98003724 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: P TALBOT Requester: CADENT MEDICAL CORP Subject: DKT 98M-0038 Control No: 98003725 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: F FERGUSON Requester: FERGUSON MEDICAL Subject: DKT 97M-0458 Control No: 98003726 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: Requester: RESPONSE Subject: A/C CLNCL CHEM & CLNCL TOX DEVICE PANEL - TRANS 12/10/97 Control No: 98003727 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRSW140 Signature: Requester: FOI SERVICES INC Subject: BIOASSAY LABS, HOUSTON, TX - EIR, 483 8/97 TO PRESENT Control No: 98003728 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRMA140 HFRMA240 HFRP240 HFRSE140 HFRSE240 HFRSE340 HFR SE440 HFRSW140 HFS22 Signature: L ANDREWS Requester: AMERIPURE PROCESSING CO Subject: CASE/CMPLNT NOS LOS7318-HM38E FLA 9509; DAL9131-M33E DAL 9097; FLA8836-WM82E DAL9097; ETC - RAW OYSTERS/VIBRIO VULNIFICUS RECS Control No: 98003729 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRNE140 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: CLINIQUE LABS - LTR DTD 9/26/97 OF INSPECTION FOR ESTEE LAUDER 9/17,23/97 Control No: 98003730 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: A NESTEBY Requester: NATIONAL WOMEN'S HEALTH NETWORK Subject: W L GORE & ASSOCS - GORTEX SURGICAL MESH RECS/RISKS & SIDE EFFECTS, CLAIMS/LAW- SUITS Control No: 98003731 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: J HAUSHEER Requester: STERI-OSS INC Subject: STRAUMANN CO - K955369 510K SUMMARY Control No: 98003732 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFS22 Signature: L KLEE Requester: BP AMERICA INC Subject: TOTAL DIET STUDY RESULTS 1991-1996 Control No: 98003733 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRNE240 Signature: J HARTTEN Requester: AKIN GUMP STRAUSS HAUER & FELD Subject: BRYAN CORP, WOBURN, MA - EIR, 483 1/1/94 TO PRESENT Control No: 98003734 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-1679 Control No: 98003735 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-2227 Control No: 98003736 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: FOI SERVICES INC Subject: 98-3044 Control No: 98003737 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: RESPONSE Subject: 97-42225 - REQUEST & RESPONSE LTR Control No: 98003738 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: ADMINISTRATOR Requester: RESPONSE Subject: A/C PSYCHOPHARMACOLOGIC DRUGS - TRANS 12/4/97 Control No: 98003739 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-41156 Control No: 98003740 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: RESPONSE Subject: 97-40016 REQUEST & RESPONSE LTR Control No: 98003741 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-42072 Control No: 98003742 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: RESPONSE Subject: 97-379 - REQUEST & RESPONSE LTR Control No: 98003743 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: ADMINISTRATOR Requester: RESPONSE Subject: 97-43074 Control No: 98003744 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFI35 Signature: Requester: RESPONSE Subject: 97-42874 - REQUEST & RESPONSE LTR Control No: 98003745 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: C COBB Requester: AAC CONSULTING GROUP INC Subject: ALPHARMA - PERMETHRIN CREAM NDA 74-806 APRVL LTR, LBLG, RVWS Control No: 98003746 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFRNE140 Signature: R QUINE Requester: D&E PHARMACEUTICALS INC Subject: NUTRITION WAREHOUSE, MINEOLA, NY - EIR, 483, NAF, ETC 1/85-PRESENT Control No: 98003747 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFS22 Signature: F CARVILL Requester: SIDLEY & AUSTIN Subject: DIETARY SUPPLEMENT HEALTH & EDUCATION ACT - COURTESY LTRS 3/15/97-PRESENT Control No: 98003748 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFZ82 Signature: B LEWIS Requester: MEMORIAL MEDICAL CENTER Subject: ALLERGAN/AMO SURGICAL PRODS - RE-USABLE HIGH VAC TUBING OM21 RECS Control No: 98003749 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFA305 Signature: T JOHNSON Requester: MGI PHARMA INC Subject: METHODS FOR CONDUCTING RECALL EFFECTIVENESS CHECKS - GUIDE Control No: 98003750 Received Date: 02/06/98 Due Date: 03/09/98 Action Offices: HFD205 Signature: P BUDAY Requester: PORTON INTERNATIONAL INC Subject: A/C CARDIOVASCULAR & RENAL DRUGS - HANDOUTS 1/27/98