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