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Home : FDA Drug Database : Acth : FDA Information : Drug and Device Product Approvals for May 1996 Drug and Device Product Approvals for May 1996
Drug and Device Product Approvals for May 1996***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS16-191 SORBITRATE ZENECA ISOSORBIDE DINITRATE01-APR-96 (TABLET, SUBLINGUAL) WILMINGTON, DE 2.5MG(SUPPL-033) 19850 5MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)]16-192 SORBITRATE ZENECA ISOSORBIDE DINITRATE01-APR-96 (TABLET) WILMINGTON, DE 5MG(SUPPL-041) 19850 10MG 20MG 30MG 40MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)]16-776 SORBITRATE ZENECA ISOSORBIDE DINITRATE01-APR-96 (TABLET, CHEWABLE) WILMINGTON, DE 5MG(SUPPL-034) 19850 10MG (VASODILATOR) [MET CONDITIONS FOR APPROVAL PER FEDERAL REGISTER NOTICE OF AUGUST 3, 1984 (49 FR 31151)]20-279 DERMATOP HOECHST ROUSSEL PREDNICARBATE03-MAY-96 (CREAM) BRIDGEWATER, NJ 0.1%(SUPPL-001) 08807 (PATIENT POPULATION ALTERED -- ADDITION OF PEDIATRIC USE TO THE APPROVED LABELING)20-340 TEMOVATE GLAXO CLOBETASOL PROPIONATE03-MAY-96 (CREAM) RES TRIANGLE PK, NJ 0.05%(SUPPL-001) 27709 (NEW DOSAGE REGIMEN -- REMOVAL OF THE RESTRICTIONS LIMITING TREATMENT TO TWO CONSECUTIVE WEEKS AND TO SMALL AREAS)20-031 PAXIL SMITHKLINE BEECHAM PAROXETINE HYDROCHLORIDE07-MAY-96 (TABLET) KING OF PRUSSIA, PA EQ 10MG BASE(SUPPL-007, 19406 EQ 20MG BASE009) EQ 30MG BASE EQ 40MG BASE (NEW INDICATION -- TREATMENT OF OBSESSIVE COMPULSIVE DISORDER AND PANIC DISORDER)50-674 VANTIN UPJOHN CEFPODOXIME PROXETIL07-MAY-96 (TABLET) KALAMAZOO, MI EQ 100MG BASE(SUPPL-005) 49001 EQ 200MG BASE (NEW DOSAGE REGIMEN -- REVISED REGIMEN FOR PHARYNGITIS/TONSILLITIS)50-675 VANTIN UPJOHN CEFPODOXIME PROXETIL07-MAY-96 (GRANULE, KALAMAZOO, MI EQ 50MG BASE/5ML(SUPPL-008) FOR RECONSTITUTION) 49001 EQ 100MG BASE/5ML (NEW DOSAGE REGIMEN -- REVISED REGIMEN FOR PHARYNGITIS/TONSILLITIS)50-585 ROCEPHIN ROCHE CEFTRIAXONE SODIUM08-MAY-96 (INJECTABLE) NUTLEY, NJ EQ 250MG BASE/VIAL(SUPPL-044) 07110 EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL (NEW DOSAGE REGIMEN -- PROVIDES FOR A MORE CONCENTRATED SOLUTION OF 350MG/ML)50-684 ZOSYN LEDERLE LABS PIPERACILLIN SODIUM08-MAY-96 (INJECTABLE) PHILADELPHIA, PA EQ 2GM BASE/VIAL(SUPPL-001) 19101 TAZOBACTAM SODIUM EQ 250MG BASE/VIAL (NEW INDICATION -- TREATMENT OF NOSOCOMIAL PNEUMONIA)50-684 ZOSYN LEDERLE LABS PIPERACILLIN SODIUM08-MAY-96 (INJECTABLE) PHILADELPHIA, PA EQ 3GM BASE/VIAL(SUPPL-001) 19101 TAZOBACTAM SODIUM EQ 375MG BASE/VIAL (NEW INDICATION -- TREATMENT OF NOSOCOMIAL PNEUMONIA)50-684 ZOSYN LEDERLE LABS PIPERACILLIN SODIUM08-MAY-96 (INJECTABLE) PHILADELPHIA, PA EQ 4GM BASE/VIAL(SUPPL-001) 19101 TAZOBACTAM SODIUM EQ 500MG BASE/VIAL (NEW INDICATION -- TREATMENT OF NOSOCOMIAL PNEUMONIA)20-555 AXID AR WHITEHALL ROBINS NIZATIDINE09-MAY-96 (TABLET) MADISON, NJ 75MG(3 S) 07940 (HISTAMINE H2-RECEPTOR ANTAGONIST) [UP TO TWICE DAILY USE FOR PREVENTION OF MEAL- INDUCED HEARTBURN, ACID INDIGESTION, AND SOUR STOMACH WHEN TAKEN 30 TO 60 MINUTES PRIOR TO CONSUMING FOOD AND BEVERAGES] (OTC)20-539 LAMISIL SANDOZ TERBINAFINE HYDROCHLORIDE10-MAY-96 (TABLET) EAST HANOVER, NJ EQ 250MG BASE(3 S) 07936 (ANTIFUNGAL) [TREATMENT OF ONYCHOMYCOSIS OF THE TOENAIL OR FINGERNAIL DUE TO DERMATOPHYTES (TINEA UNGUIUM)]20-572 BUPHENYL UCYCLYD SODIUM PHENYLBUTYRATE13-MAY-96 (TABLET) HUNT VALLEY, MD 500MG(3 P, V*) 21031 (HYPERAMMONEMIA AGENT) [ADJUNCTIVE THERAPY IN THE CHRONIC MANAGEMENT OF PATIENTS WITH UREA CYCLE DISORDERS]V* - Designated Orphan Drug 20-449 TAXOTERE RHONE POULENC DOCETAXEL14-MAY-96 (INJECTABLE) COLLEGEVILLE, PA EQ 40MG BASE/ML(1 P, H**) 19426 (ANTINEOPLASTIC) [TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAVE PROGRESSED OR RELAPSED DURING ANTHRACYCLINE-BASED THERAPY]20-509 GEMZAR LILLY GEMCITABINE HYDROCHLORIDE15-MAY-96 (INJECTABLE) INDIANAPOLIS, IN EQ 200MG BASE/VIAL(1 P) 46285 EQ 1GM BASE/VIAL (ANTINEOPLASTIC) [FIRST-LINE TREATMENT FOR PATIENTS WITH ADVANCED OR METASTATIC ADENOCARCINOMA OF THE PANCREAS AND THOSE WHO WERE PREVIOUSLY TREATED WITH 5-FU]20-647 ELDEPRYL SOMERSET SELEGILINE HYDROCHLORIDE15-MAY-96 (CAPSULE) TAMPA, FL 5MG(3 S) 33607 (ANTIDYSKINETIC) [ADJUNCTIVE TREATMENT OF PARKINSON'S DISEASE]20-007 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE16-MAY-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 2MG BASE/ML(SUPPL-020) 27709 (NEW INDICATION -- PREVENTION, AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN PEDIATRIC PATIENTS RECEIVING GENERAL ANESTHESIA)20-007 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE16-MAY-96 PRESERVATIVE FREE RES TRIANGLE PK, NC EQ 2MG BASE/ML(SUPPL-020) (INJECTABLE) 27709 (NEW INDICATION -- PREVENTION, AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN PEDIATRIC PATIENTS RECEIVING GENERAL ANESTHESIA)H** - Accelerated Approval (drug is intended to treat a serious or life-threatening illness and provide a meaningful therapeutic benefit over existingtreatments, and the NDA was approved under the provisions of 21 CFR 314Subpart H)20-298 ZYLOPRIM GLAXO WELLCOME ALLOPURINOL SODIUM17-MAY-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 500MG BASE/VIAL(3 P, V*) 27709 (XANTHINE OXIDASE INHIBITOR) [MANAGEMENT OF PATIENTS RECEIVING CANCER THERAPY WHICH CAUSES ELEVATIONS OF SERUM AND URINARY URIC ACID LEVELS AND WHO CANNOT TOLERATE ORAL THERAPY]20-457 ETOPOPHOS BRISTOL MYERS SQUIBB ETOPOSIDE PHOSPHATE17-MAY-96 (INJECTABLE) WALLINGFORD, CT EQ 100MG BASE/VIAL(2 S) 06492 (ANTINEOPLASTIC) [MANAGEMENT OF SMALL CELL LUNG CANCER, FIRST-LINE, AND REFRACTORY TESTICULAR TUMORS, IN COMBINATION WITH OTHER CHEMOTHERAPEUTIC AGENTS]19-798 NASACORT RHONE POULENC RORER TRIAMCINOLONE ACETONIDE20-MAY-96 (AEROSOL, METERED) COLLEGEVILLE, PA 0.055MG/INH (SUPPL-006) 19426 (NEW INDICATION -- USE IN PATIENTS 6 TO 11 YEARS OF AGE)20-195 FENTANYL ORALET ANESTA FENTANYL CITRATE20-MAY-96 (TROCHE) SALT LAKE CITY, UT EQ 0.1MG BASE(SUPPL-002) 84116 EQ 0.2MG BASE EQ 0.3MG BASE EQ 0.4MG BASE (PATIENT POPULATION ALTERED -- LOWERING THE WEIGHT OF CHILDREN WHO MAY BE ADMINISTERED FENTANYL ORALET FROM 15KG TO NOT LESS THAN 10KG) 20-468 NASACORT AQ RHONE POULENC RORER TRIAMCINOLONE ACETONIDE20-MAY-96 (SPRAY, METERED) COLLEGEVILLE, PA 0.055MG/INH(3 S) 19426 (CORTICOSTEROID) [TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS]V* - Designated Orphan Drug 20-575 LIDOCAINE TRANSORAL NOVEN PHARMA LIDOCAINE21-MAY-96 DELIVERY SYSTEM MIAMI, FL 23MG/PATCH(3 S) (FILM, 33186 46.1MG/PATCH EXTENDED RELEASE) (ANESTHETIC, TOPICAL) [INDUCTION OF ANESTHESIA OF THE BUCCAL MUCOSA BEFORE AN INTRAORAL INJECTION]19-921 OCUFLOX ALLERGAN OFLOXACIN22-MAY-96 (SOLUTION) IRVINE, CA 0.3%(SUPPL-003) 92713 (NEW INDICATION -- TREATMENT OF BACTERIAL CORNEAL ULCERS)20-080 IMITREX GLAXO WELLCOME SUMATRIPTAN SUCCINATE22-MAY-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 6MG BASE/0.5ML(SUPPL-004) 27709 (NEW INDICATION -- ACUTE TREATMENT OF CLUSTER HEADACHE)20-162 ACTHREL FERRING LABS CORTICORELIN OVINE 23-MAY-96 (INJECTABLE) SUFFERN, NY TRIFLUTATE(1 P, V*) 10901 EQ 0.1MG BASE/VIAL (PEPTIDE) [USE IN DIFFERENTIATING PITUITARY AND ECTOPIC PRODUCTION OF ACTH IN PATIENTS WITH ACTH- DEPENDENT CUSHING'S SYNDROME]20-671 HYCAMTIN SMITHKLINE BEECHAM TOPOTECAN HYDROCHLORIDE28-MAY-96 (INJECTABLE) KING OF PRUSSIA, PA EQ 4MG BASE/VIAL(1 P) 19406 (ANTINEOPLASTIC) [TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR SUBSEQUENT CHEMOTHERAPY]20-338 DIFFERIN GALDERMA ADAPALENE31-MAY-96 (SOLUTION) FORT WORTH, TX 0.1%(1 S) 76163 (ANTIACNE) [TOPICAL TREATMENT OF ACNE VULGARIS]20-380 DIFFERIN GALDERMA ADAPALENE31-MAY-96 (GEL) FORT WORTH, TX 0.1%(3 S) 76163 (ANTIACNE) [TOPICAL TREATMENT OF ACNE VULGARIS]V* - Designated Orphan Drug50-725 AUGMENTIN '200' SMITHKLINE BEECHAM AMOXICILLIN31-MAY-96 (POWDER PHILADELPHIA, PA 200MG/5ML(3 S) FOR RECONSTITUTION) 19101 CLAVULANATE POTASSIUM EQ 28.5MG BASE/5ML (ANTIBIOTIC, PENICILLIN/ BETA LACTAMASE ENZYME INACTIVATOR)50-725 AUGMENTIN '400' SMITHKLINE BEECHAM AMOXICILLIN31-MAY-96 (POWDER PHILADELPHIA, PA 400MG/5ML(3 S) FOR RECONSTITUTION) 19101 CLAVULANATE POTASSIUM EQ 57MG BASE/5ML ANTIBIOTIC, PENICILLIN/ BETA LACTAMASE ENZYME INACTIVATOR)50-726 AUGMENTIN '200' SMITHKLINE BEECHAM AMOXICILLIN31-MAY-96 (TABLET, CHEWABLE) PHILADELPHIA, PA 200MG(3 S) 19101 CLAVULANATE POTASSIUM EQ 28.5MG BASE (ANTIBIOTIC, PENICILLIN/ BETA LACTAMASE ENZYME INACTIVATOR)50-726 AUGMENTIN '400' SMITHKLINE BEECHAM AMOXICILLIN31-MAY-96 (TABLET, CHEWABLE) PHILADELPHIA, PA 400MG(3 S) 19101 CLAVULANATE POTASSIUM EQ 57MG BASE (ANTIBIOTIC, PENICILLIN/ BETA LACTAMASE ENZYME INACTIVATOR) ***APPROVABLE ORIGINAL NDAs***An approvable letter indicates that FDA is prepared to approve the applicationupon the satisfaction of conditions specified in the approvable letter.Drug products which are the subject of approvable letters may not be legallymarketed until the firm has satisfied the identified deficiencies, as well asany other requirements that may be imposed by FDA, and has been notified inwriting that the application has been approved. Further information onapprovable NDAs is not subject to Freedom of Information (FOI) release untilapplications are approved.20-509 GEMZAR ELI LILLY GEMCITABINE HYDROCHLORIDE02-MAY-96 (INJECTABLE) INDIANAPOLIS, IN EQ 1MG BASE/VIAL 46285 (ANTINEOPLASTIC)20-509 GEMZAR ELI LILLY GEMCITABINE HYDROCHLORIDE02-MAY-96 (SOLUTION) INDIANAPOLIS, IN EQ 200MG BASE/VIAL 46285 (ANTINEOPLASTIC)20-410 GASTROMARK ADVANCED MAGNETICS FERUMOXSIL07-MAY-96 (SUSPENSION) CAMBRIDGE, MA EQ 0.175MG FE/ML 02138 (MRI CONTRAST MEDIA)20-588 RISPERDAL JANSSEN RISPERIDONE20-MAY-96 (SOLUTION) TITUSVILLE, NJ 1MG/ML 05860 (ANTIPSYCHOTIC)50-711 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE22-MAY-96 (TABLET) GROTON, CT EQ 250MG BASE 06340 (ANTIBIOTIC, MACROLIDE)20-529 CONDYLOX OCLASSEN PHARM PODOFILOX23-MAY-96 (GEL) SAN RAFAEL, CA 0.5% 94901 (ANTIMITOTIC)20-352 IMODIUM A-D MCNEIL CONS PRODS LOPERAMIDE HYDROCHLORIDE24-MAY-96 (TABLET) FORT WASHINGTON, PA 2MG 19034 (ANTIDIARRHEAL) (OTC)20-544 NORPLANT II POPULATION COUNCIL LEVONORGESTREL31-MAY-96 (IMPLANT) NEW YORK, NY 75MG/IMPLANT 10021 (PROGESTIN)20-605 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE31-MAY-96 (SOLUTION) RES TRIANGLE PK, NC EQ 4MG BASE/5ML 27709 (ANTIEMETIC) ***ORIGINAL ABBREVIATED NDAs***40-079 THIAMINE HCL SANOFI WINTHROP THIAMINE HYDROCHLORIDE03-MAY-96 (INJECTABLE) NEW YORK, NY 100MG/ML 10016 (VITAMIN)64-131 AMOXICILLIN APOTHECON AMOXICILLIN06-MAY-96 (TABLET, CHEWABLE) PRINCETON, NJ 125MG 08543 250MG (ANTIBIOTIC, PENICILLIN)74-285 DIFLUNISAL PUREPAC PHARM DIFLUNISAL07-MAY-96 (TABLET) ELIZABETH, NJ 250MG 07207 500MG (NONSTEROIDAL ANTI-INFLAMMATORY)74-356 CHLORHEXIDINE HI TECH PHARMA CHLORHEXIDINE GLUCONATE07-MAY-96 GLUCONATE AMITYVILLE, NY 0.12% (SOLUTION) 11701 (ANTIMICROBIAL)74-480 NAPROXEN SODIUM WEST WARD PHARM NAPROXEN SODIUM14-MAY-96 (TABLET) EATONTOWN, NJ EQ 500MG BASE 07724 (NONSTEROIDAL ANTI-INFLAMMATORY)40-093 DIGOXIN SANOFI WINTHROP DIGOXIN16-MAY-96 (INJECTABLE) NEW YORK, NY 0.25MG/ML 10016 (CARDIAC GLYCOSIDE)74-287 PIROXICAM DANBURY PHARMA PIROXICAM16-MAY-96 (CAPSULE) DANBURY, CT 10MG 06810 20MG (NONSTEROIDAL ANTI-INFLAMMATORY)74-450 MEXILETINE HCL GENEVA PHARMS MEXILETINE HYDROCHLORIDE16-MAY-96 (CAPSULE) BROOMFIELD, CO 150MG 80038 200MG 250MG (ANTIARRHYTHMIC)64-148 CEFACLOR MARSAM CEFACLOR23-MAY-96 (CAPSULE) CHERRY HILL, NJ EQ 250MG BASE 08034 EQ 500MG BASE (ANTIBIOTIC, CEPHEM)74-386 CAPTOPRIL DANBURY PHARMA CAPTOPRIL23-MAY-96 (TABLET) DANBURY, CT 12.5MG 06810 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR)74-403 DOPAMINE HCL SANOFI WINTHROP DOPAMINE HYDROCHLORIDE23-MAY-96 (INJECTABLE) NEW YORK, NY 40MG/ML 10016 (INOTROPIC/VASOPRESSOR)74-500 MINOXIDIL (FOR MEN) COPLEY PHARM MINOXIDIL23-MAY-96 (SOLUTION) CANTON, MA 2% 02021 (HAIR GROWTH STIMULANT) (OTC)74-594 INDAPAMIDE INVAMED INDAPAMIDE23-MAY-96 (TABLET) DAYTON, NJ 1.25MG 08810 2.5MG (ANTIHYPERTENSIVE/DIURETIC) ***ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVAL***A tentative approval indicates that FDA has given an abbreviated new drugapplication (ANDA) or 505(b)(2) application provisional approval under theterms of the Drug Price Competition and Patent Term Restoration Act. Such drugproducts that are the subjects of tentative approvals may not be legallymarketed until the market exclusivity and/or patent term of the listedreference drug product has expired. Final approval is also contingent uponconditions and information available to FDA remaining acceptable. When theapplication receives final approval, the product may be legally marketed. Theeffective approval date will be listed in this publication and in the "ApprovedDrug Products with Therapeutic Equivalence Evaluations" list published by FDA. Additional information on these applications will become available to thepublic when the applications receive final approval.THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALSFOR MAY 1996. ***LABELING SUPPLEMENTS TO ORIGINAL NDAs***50-521 CECLOR ELI LILLY CEFACLOR01-MAY-96 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE 46285 EQ 500MG BASE (LABELING REVISION -- CLINICAL PHARMACOLOGY; ADVERSE REACTIONS)50-522 CECLOR ELI LILLY CEFACLOR01-MAY-96 (POWDER INDIANAPOLIS, IN EQ 125MG BASE/5ML FOR RECONSTITUTION) 46285 EQ 187MG BASE/5ML EQ 250MG BASE/5ML EQ 375MG BASE/5ML (LABELING REVISION -- CLINICAL PHARMACOLOGY; ADVERSE REACTIONS) 20-279 DERMATOP HOECHST ROUSSEL PREDNICARBATE03-MAY-96 (CREAM) BRIDGEWATER, NJ 0.01% 08807 (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)20-340 TEMOVATE GLAXO CLOBETASOL PROPIONATE03-MAY-96 (CREAM) RES TRIANGLE PK, NJ 0.05% 27709 (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)12-623 FLAGYL SEARLE METRONIDAZOLE07-MAY-96 (TABLET) SKOKIE, IL 250MG 60077 500MG (LABELING REVISION -- DESCRIPTION; CLINICAL PHARMACOLOGY; CONTRAINDICATIONS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE ANDADMINISTRATION)20-031 PAXIL SMITHKLINE BEECHAM PAROXETINE HYDROCHLORIDE07-MAY-96 (TABLET) KING OF PRUSSIA, PA EQ 10MG BASE 19406 EQ 20MG BASE EQ 30MG BASE EQ 40MG BASE (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)50-674 VANTIN UPJOHN CEFPODOXIME PROXETIL07-MAY-96 (TABLET) KALAMAZOO, MI EQ 100MG BASE 49001 EQ 200MG BASE (LABELING REVISION -- CLINICAL PHARMACOLOGY; ADVERSE REACTIONS; DOSAGE ANDADMINISTRATION)50-675 VANTIN UPJOHN CEFPODOXIME PROXETIL07-MAY-96 (GRANULE, KALAMAZOO, MI EQ 50MG BASE/5ML FOR RECONSTITUTION) 49001 EQ 100MG BASE/5ML (LABELING REVISION -- CLINICAL PHARMACOLOGY; ADVERSE REACTIONS; DOSAGE ANDADMINISTRATION)19-510 PECID MERCK FAMOTIDINE08-MAY-96 (INJECTABLE) WEST POINT, PA 10MG/ML 19486 (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)19-661 CYTOVENE IV SYNTEX LABS GANCICLOVIR SODIUM08-MAY-96 (INJECTABLE) PALO ALTO, CA EQ 500MG BASE/VIAL 94304 (LABELING REVISION -- CLINICAL PHARMACOLOGY; INDICATIONS AND USAGE; ADVERSE EVENTS)50-585 ROCEPHIN ROCHE CEFTRIAXONE SODIUM08-MAY-96 (INJECTABLE) NUTLEY, NJ EQ 250MG BASE/VIAL 07110 EQ 500MG BASE/VIAL EQ 1GM BASE/VIAL EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL (LABELING REVISION -- CLINICAL PHARMACOLOGY; DIRECTIONS FOR USE; COMPATIBILITY AND STABILITY; HOW SUPPLIED)50-684 ZOSYN LEDERLE LABS PIPERACILLIN SODIUM08-MAY-96 (INJECTABLE) PHILADELPHIA, PA EQ 2GM BASE/VIAL 19101 TAZOBACTAM SODIUM EQ 250MG BASE/VIAL (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)50-684 ZOSYN LEDERLE LABS PIPERACILLIN SODIUM08-MAY-96 (INJECTABLE) PHILADELPHIA, PA EQ 3GM BASE/VIAL 19101 TAZOBACTAM SODIUM EQ 375MG BASE/VIAL (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)50-684 ZOSYN LEDERLE LABS PIPERACILLIN SODIUM08-MAY-96 (INJECTABLE) PHILADELPHIA, PA EQ 4GM BASE/VIAL 19101 TAZOBACTAM SODIUM EQ 500MG BASE/VIAL (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)20-065 OPCON-A BAUSCH AND LOMB NAPHAZOLINE HYDROCHLORIDE09-MAY-96 (SOLUTION/DROP) ROCHESTER, NY 0.027% 14692 PHENIRAMINE MALEATE 0.315% (LABELING REVISION -- PATIENT LABELING) (OTC)18-873 MEXITIL BOEHRINGER INGELHEIM MEXILETINE HYDROCHLORIDE10-MAY-96 (CAPSULE) RIDGEFIELD, CT 150MG 06877 200MG 250MG (LABELING REVISION -- WARNINGS; ADVERSE REACTIONS; OVERDOSAGE)19-614 VERELAN ELAN PHARM VERAPAMIL HYDROCHLORIDE10-MAY-96 (CAPSULE, GAINESVILLE, GA 120MG EXTENDED RELEASE) 30504 180MG 240MG 360MG (LABELING REVISION -- DESCRIPTION; HOW SUPPLIED)50-405 KEFLEX ELI LILLY CEPHALEXIN15-MAY-96 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE 46285 EQ 500MG BASE (LABELING REVISION -- WARNINGS)50-406 KEFLEX ELI LILLY CEPHALEXIN15-MAY-96 (POWDER INDIANAPOLIS, IN EQ 125MG BASE/5ML FOR RECONSTITUTION) 46285 EQ 250MG BASE/5ML (LABELING REVISION -- WARNINGS) 50-668 LORABID ELI LILLY LORACARBEF15-MAY-96 (CAPSULE) INDIANAPOLIS, IN 200MG 46285 400MG (LABELING REVISION -- HOW SUPPLIED)20-007 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE16-MAY-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 2MG BASE/ML 27709 (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)20-007 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE16-MAY-96 PRESERVATIVE FREE RES TRIANGLE PK, NC EQ 2MG BASE/ML (INJECTABLE) 27709 (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)19-798 NASACORT RHONE POULENC RORER TRIAMCINOLONE ACETONIDE20-MAY-96 (AEROSOL, METERED) COLLEGEVILLE, PA 0.055MG/INH 19426 (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)20-195 FENTANYL ORALET ANESTA FENTANYL CITRATE20-MAY-96 (TROCHE) SALT LAKE CITY, UT EQ 0.1MG BASE 84116 EQ 0.2MG BASE EQ 0.3MG BASE EQ 0.4MG BASE (LABELING REVISION -- BOX WARNING; CONTRAINDICATIONS; PRECAUTIONS; DOSAGE ANDADMINISTRATION)50-517 MEFOXIN MSD CEFOXITIN SODIUM20-MAY-96 (INJECTABLE) WEST POINT, PA EQ 1GM BASE/VIAL 19486 EQ 2GM BASE/VIAL EQ 10GM BASE/VIAL (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)50-581 MEFOXIN MSD CEFOXITIN SODIUM20-MAY-96 IN DEXTROSE 5% WEST POINT, PA EQ 20MG BASE/ML IN PLASTIC CONTAINER 19486 EQ 40MG BASE/ML (INJECTABLE) (LABELING REVISION -- SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)19-921 OCUFLOX ALLERGAN OFLOXACIN 22-MAY-96 (SOLUTION) IRVINE, CA 0.3% 92713 (LABELING REVISION -- INDICATION AND USAGE)20-080 IMITREX GLAXO WELLCOME SUMATRIPTAN SUCCINATE22-MAY-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 6MG BASE/0.5ML 27709 (LABELING REVISION -- INDICATIONS AND USAGE)20-083 SPORANOX JANSSEN ITRACONAZOLE23-MAY-96 (CAPSULE) PISCATAWAY, NJ 100MG 08855 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; INDICATIONS AND USAGE; CONTRAINDICATIONS; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE ANDADMINISTRATION; HOW SUPPLIED)08-107 LEUCOVORIN CALCIUM IMMUNEX LEUCOVORIN CALCIUM24-MAY-96 (INJECTABLE) SEATTLE, WA EQ 50MG BASE/VIAL 98101 EQ 100MG BASE/VIAL EQ 350MG BASE/VIAL (LABELING REVISION -- INDICATIONS AND USAGE; WARNINGS; DOSAGE AND ADMINISTRATION)20-388 NAVELBINE GLAXO WELLCOME VINORELBINE TARTRATE24-MAY-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 10MG BASE/ML 27709 (LABELING REVISION -- ADVERSE REACTIONS)20-403 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE24-MAY-96 IN PLASTIC CONTAINER RES TRIANGLE PK, NC EQ 0.64MG BASE/ML PRESERVATIVE FREE 27709 (LABELING REVISION -- (INJECTABLE) SECTION(S) OF LABELING REVISED NOT SPECIFIED IN APPROVAL LETTER)19-471 CARDIZEM SR HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE28-MAY-96 (CAPSULE, KANSAS CITY, MO 60MG EXTENDED RELEASE) 64134 90MG 120MG (LABELING REVISION -- WARNINGS; ADVERSE REACTIONS; OVERDOSAGE) 19-762 TESTODERM ALZA CORP TESTOSTERONE28-MAY-96 (FILM, PALO ALTO, CA 4MG/24HR EXTENDED RELEASE) 94303 6MG/24HR (LABELING REVISION -- WARNINGS; ADVERSE REACTIONS; PATIENT PACKAGE INSERT)19-661 CYTOVENE IV SYNTEX LABS GANCICLOVIR SODIUM29-MAY-96 (INJECTABLE) PALO ALTO, CA EQ 500MG BASE/VIAL 94304 (LABELING REVISION -- CLINICAL PHARMACOLOGY; INDICATIONS AND USAGE; PRECAUTIONS; DOSAGE ANDADMINISTRATION; HOW SUPPLIED)20-249 PEPCID MERCK FAMOTIDINE31-MAY-96 PRESERVATIVE FREE WEST POINT, PA 0.4MG/ML (INJECTABLE) 19486 (LABELING REVISION -- HOW SUPPLIED) ***BIOLOGICAL PRODUCT LICENSES ISSUED***0181 NONE FLORIDA GEORGIA BLOOD SOURCE LEUKOCYTES06-MAY-96 (INJECTABLE) ALLIANCE (B) JACKSONVILLE, FL 322061203 NONE GREEN STREET BIOLGS SOURCE PLASMA06-MAY-96 (INJECTABLE) LAFAYETTE, LA (A,B) 705061204 AVONEX BIOGEN INTERFERON BETA-LA17-MAY-96 (INJECTABLE) CAMBRIDGE, MA (A,B) 02142(A) Establishment License Issued(B) Product License Issued ***BIOLOGICAL PRODUCT DEVICE APPROVALS***BP900003 CONFIDE DIRECT ACCESS DIAG HIV-BLOOD TESTING SERVICE14-MAY-96 BRIDGEWATER, NJ (D) 08807BK960010 NONE BAXTER HLTHCARE CELL WASH SET22-MAY-96 IRVINE, CA (C) 91203(C) Substantially Equivalent(D) Approved ***MEDICAL DEVICE - PREMARKET APPROVAL APPLICATIONS***THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICALHEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIORTO PUBLICATIONP910072 SYVA MICRO BEHRING DIAGNOSTICS, USE AN AID IN THE05/13/96 TRAK(R)II IGM INC. DIAGNOSIS OF ACUTE ANTI-HAV EIA SAN JOSE, CA OR RECENT HEPATITIS 95161 INFECTION (USUALLY SIX MONTHS OR LESS) P920023 UROLUME AMERICAN MEDICAL USE IN MEN TO RELIEVE05/06/96 ENDOURETHRAL SYSTEMS, INC. URINARY OBSTRUCTION PROSTHESIS MINNETONKA, MN SECONDARY TO RECURRENT 55343 BENIGN BULBAR URETHRAL STRICTURES P940019 WALLSTENT SCHNEIDER (USA), INC. INDICATED FOR USE 05/28/96 ILIAC PLYMOUTH, MN FOLLOWING SUBOPTIMAL ENDOPROSTHESIS 55442 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF COMMON AND/OR EXTERNAL ILIAC ARTERY STENOTIC LESIONSP950001 SELUTE STEROID GUIDANT, CORP. INDICATED FOR CHRONIC05/08/96 ELUTING ST PAUL, MN PACING AND SENSING ENDOCARDIAL LEAD 55112-5798 OF THE VENTRICLE MODELS 4185 AND WHEN USED WITH A 4285 COMPATIBLE PULSE GENERATORP950014 PROSTATRON EDAP TECHNOMED A NON-SURGICAL 05/03/96 GROUP (USA), INC. TREATMENT ALTERNATIVE CAMBRIDGE, MA TO TRANSURETHRAL 02139 RESECTION OF THE PROSTATE (TURP) FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)P950022 TVL LEAD SYSTEM VENTRITEX, INC. INDICATED FOR USE AS05/10/96 SUNNYVALE, CA A TRANSVENOUS 94086-6527 DEFIBRILLATION LEAD SYSTEM IN PATIENTS WITH A HISTORY OF HEMODYNAMICALLY VENTRICULAR TACHYARRHYTHMIASP950039 THINPREP CYTYC, CORP. REPLACEMENT FOR THE 05/20/96 2000 SYSTEM MARLBOROUGH, MA CONVENTIONAL METHOD 01752 OF PAP SMEAR PREPARATION IN SCREENING FOR ATYPICAL CELLS, CERVICAL CANCER, OR PRECURSOR LESIONS ***MEDICAL DEVICE - PMA SUPPLEMENTALS***THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICALHEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIOR TOPUBLICATIONN12159/S016 SURGICEL JOHNSON & JOHNSON APPROVAL FOR THE 05/15/96 FIBRILLAR MEDICAL, INC. 4"X4" SIZE OF ABSORBABLE ARLINGTON, TX SURGICEL FIBRILLAR HEMOSTAT 76004-3130 ABSORBABLE HEMOSTATP790017/S058 USCI GRUNTZIG C.R. BARD, INC. APPROVAL FOR THE USCI05/13/96 DILICA CORONARY BILLERICA, MA PROCROSS ELITE OVER ARTERY AND USCI 01821 THE WIRE BALLOON PROCROSS ELITE DILATATION CATHETER OVER THE WIRE WITH PRO/PEL COATING BALLOON AND ANTI BACK BLEED DILATATION DEVICE CATHETERSP790018/S024 MEDTRONIC HALL MEDTRONIC, INC. APPROVAL FOR THE USE 05/13/96 PROSTHETIC HEART MINNEAPOLIS, MN OF OCCLUDERS MADE BY VALVE AND VALVED 55440 MEDTRONIC CARBON CONDUITS MODELS IMPLANTS (MCI) OF A7700, M7700, AUSTIN, TEXAS, AS A C7700, AND Z7700 COMPONENT TO THE DEVICE P790019/S006 HAVAB-M ABBOTT LABORATORIES APPROVAL TO EXTEND 05/29/96 DIAGNOSTIC KIT NORHT CHICAGO, IL EXPIRATION DATING TO 60064-3500 70 DAYS FROM THE DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUSP790019/S007 HAVAB-M EIA ABBOTT LABORATORIES APPROVAL TO EXTEND 05/29/96 DIAGNOSTIC KIT ABBOTT PARK, IL EXPIRATION DATING TO 60064-3500 8 MONTHS FROM THE DATE OF MANUFACTURE WHEN STORED AT 2-8 DEGREES CELSIUSP790025/S006 ABBOTT HBE ABBOTT LABORATORIES MODIFIED LABELING 05/17/96 (RDNA) EIA ABBOTT PARK, IL TO ENHANCE THE SAFETY 60064-3500 IN THE USE OF THE DEVICE P790027/S059 POSTERIOR AND CHIRON VISION CORP. IMPLEMENTATION OF NEW05/01/96 ANTERIOR CHAMBER CLAREMONT, CA MANUFACTURING POLYMETHYLMETHA- 91711 PROCESSES OF CLEAR CRYLATE AND VIOLET HAPTIC INTRAOCULAR LENSES POLYMETHLYMETHACRYLATE (PMAA) ONE-PIECE POSTERIOR CHAMBER LENSESP810002/S040 ST. JUDE MEDICAL ST. JUDE MEDICAL, INC. INCREASE OF THE 05/01/96 MECHANICAL HEART ST. PAUL, MN LEAFLET LOT SIZES VALVE 55117 DURING THE PYROLYTIC CARBON COATING PROCESS P810002/S042 ST. JUDE MEDICAL ST. JUDE MEDICAL, INC. LABELING CHANGE 05/14/96 MECHANICAL HEART ST. PAUL, MN VALVE 55117 P830026/S065 RX5000 INTERMEDICS, INC. ALTERNATE COMPONENTS05/30/96 PROGRAMMER ANGLETON, TX MODEL 522-12 77515P830055/S047 NEW JERSEY LCS DEPUY, INC. COMBINATION LABELING 05/06/96 TOTAL KNEE SYSTEM WARSAW, IN TO INCLUDE THE CEMENTED 46581-0988 AND CEMENTLESS DEVICE CONFIGURATIONS OF THE NEW JERSEY LCS TOTAL KNEE SYSTEM INTO ONE SINGLE LABELP840024/S062 NUCLEUS 22 COCHLEAR, CORP. MODIFICATIONS TO THE 05/20/96 CHANNEL COCHLEAR ENGLEWOOD, CO EXTERNAL TRANSMITTER IMPLANT SYSTEM 80112 COIL TO LIMIT ESD ENERGY BEING TRANSMITTED TO THE IMPLANT BY THE COIL P850048/S012 TANDEM-R PSA HYBRITECH, INC. CHANGE IN HYBRITECH'S05/03/96 IMMUNORADIOMETRIC SAN DIEGO, CA IMMUNOENZYMETRIC PSA ASSAY & TANDEM-E 921269006 ASSAY FROM A BEAD PSA IMMUNOENZYMETRIC FORMAT TO A ASSAY MICROPLATE (MP) FORMAT (TANDEM-MP PSA ASSAY)P850059/S016 POSTERIOR AND CHIRON VISION CORP. NEW MANUFACTURING05/01/96 ANTERIOR CHAMBER CLAREMONT, CA PROCESS, NEW TUMBLING POLYMETHYLMETHA- 91711 PROCESS, AND CRYLATE INTRODUCTION OF INTRAOCULAR LENSES SEVERAL NEW TIER A POSTERIOR CHAMBER LENSES P860003/S027 UVAR THERAKOS MANUFACTURING SITE 05/17/96 PHOTOPHORESIS WEST CHESTER, PA CHANGE FOR THE TPS102 SYSTEM 19380 PHOTOCEPTOR COMPONENT OF THE UVAR PHOTOPHERESIS SYSTEM FROM THERAKOS TO HARMAC MEDICAL PRODUCTS P860007/S016 INTERTACH INTERMEDICS, INC. ALTERNATE 05/21/96 FAMILY OF ANGLETON, TX STERILIZATION PROCESS PULSE GENERATORS 77515 P860059/S075 UV-ABSORBING ALLERGAN MEDICAL APPROVAL FOR TIER A 05/30/96 POSTERIOR CHAMBER OPTICS POSTERIOR CHAMBER INTRAOCULAR LENSES IRVINE, CA LENSES, MODELS 92713-9534 UPB38ON, UPB38OC, UPB320F, UPB320V, UPB330F, UPB382, AND UPB300FP870013/S008 POSTERIOR AND CHIRON VISION CORP. NEW MANUFACTURING 05/01/96 ANTERIOR CHAMBER CLAREMONT, CA PROCESS, NEW POLYMETHYLMETHA- 91711 TUMBLING PROCESS, CRYLATE INTRODUCTION OF INTRAOCULAR LENSES SEVERAL TIER A POSTERIOR CHAMBER LENSESP870015/S024 MEDSTONE STS MEDSTONE INTL., INC. REVISION TO THE 05/24/96 LITHOTRIPTER ALISO VIEJO, CA "PRECAUTIONS" SECTION 92656-4114 OF THE USER'S MANUAL P870049/S025 MICROSCAN DADE INTL., INC. EXPANDED GENTAMICIN05/03/96 RAPID FLUOROGENIC WEST SACRAMENTO, CA DILUTIONS AND THE PANELS-GENTAMCIN 95691 REMOVAL OF LIMITATION GRAM-NEGATIVE FOR TESTING OF PANELS SALMONELLA/SHIGELLA WITH GENTAMICIN AND ADDITIONAL LIMITATIONS P870072/S002 THORATEC THORATEC LABORATORIES ADD AN INCOMING 05/01/96 VENTRICULAR CORP. INSPECTION TEST ASSIST DEVICE BERKELEY, CA TO THE QUALITY (VAD) SYSTEM 94710-2090 ASSURANCE PROCEDURES FOR EPROM INTEGRATED CIRCUITSP880003/S057 CORDIA PTCA CORDIS CORPORATION APPROVAL FOR TITAN 05/06/96 DILATION CATHETER MIAMI, FL AND TITAN XL PTCA 33102-5700 DILATATION CATHETERS WITH 4.5MM AND 5.0MM DIAMETER BALLOONS AVAILABLE IN 20MM LENGTHS; AND A MODIFIED HUB BONDINGP890017/S004 PALMAZ BALLOON- JOHNSON & JOHNSON ALTERNATE 05/20/96 EXPANDABLE STENT/ INTERVENTIONAL MANUFACTURING ILIAC ARTERIES WARREN, NJ FACILITY FOR 07059 FINISHING, PACKAGING, AND DISTRIBUTION OF THE DEVICEP890027/S031 NUCLEUS 22 COCHLEAR, CORP. MODIFICATIONS TO THE 05/20/96 CHANNEL COCHLEAR ENGLEWOOD, CO EXTERNAL TRANSMITTER IMPLANT 80112 COIL TO LIMIT ESD ENERGY BEING TRANSMITTED TO THE IMPLANT BY THE COIL P900023/S018 ABIOMED BVS 5000 ABIOMED, INC. CLARIFICATION OF THE 05/02/96 BI-VENTRICULAR DANVERS, MA LABELED INDICATION SUPPORT SYSTEM 01923 P900043/S002 PALMAZ-SCHATZ JOHNSON & JOHNSON REVISED LABELING 05/01/96 BALLOON INTERVENTIONAL SYSTEMS EXPANDABLE STENT WARREN, NJ 07059P900056/S014 ROTABLATOR HEART TECHNOLOGY, INC. APPROVAL FOR THE 05/16/96 ROTATIONAL REDMOND, WA SUPPORT ROTAWIRE AND ANGIOPLASTY 98052-3376 RAIL ROTAWIRE GUIDE SYSTEM WIRES FOR USE WITH THE ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEMP900061/S017 MEDTRONIC MODELS MEDTRONIC, INC. APPROVAL FOR 05/07/96 7200B/C/D/E MINNEAPOLIS, MN MEDTRONIC MODELS 55432-3576 7220B/C/D/E WITH MODIFIED MICROPROCESSORP910020/S013 MARATHON FAMILY INTERMEDICS, INC. APPROVAL FOR THE 05/03/96 OF PULSE ANGLETON, TX MARATHON FAMILY OF GENERATORS AND 77515 PULSE GENERATORS AND THE MODEL 531-66 THE MODEL 531-66 GRAPHICS PROGRAM GRAPHICS PROGRAM MODULE MODULE P910023/S013 CADENCE TIERED VENTRITEX, INC. ALTERNATIVE 05/13/96 THERAPY SUNNYVALE, CA STERILIZATION PROCESS DEFIBRILLATOR 94086-6527 AND USE OF EASY-TO- SYSTEM RETRIEVE BIOLOGICAL INDICATORS P910023/S019 CADET TIERED VENTRITEX, INC. APPROVAL FOR THE 05/07/96 THERAPY SUNNYVALE, CA CADET TIERED THERAPY DEFIBRILLATOR 94086-6527 DEFIBRILLATOR SYSTEM SYSTEM (PECTORAL USE)P910031/S007 CATHSCANNER ORACLE ENDOSONICS CORP. ADDITIONAL05/30/96 MICRO PTCA RANCHO CORDOVA, CA MANUFACTURING SITE: CATHETER, FACT, 95670 IRVINE, CA. AND AND ARC BALLOON ALTERNATE CORONARY STERILIZATION SITE: DILATATION CATHETER LOS ANGELES, CA. P910073/S020 ENDOTAK C LEAD GUIDANT, CORP. ADDITION OF A SUB 05/15/96 MODELS, SQ PATCH ST.PAUL, MN POPULATION TO THE MODELS, SQ LEAD 55112-5798 INDICATIONS FOR USE ARRAY MODELS, FOR ENDOTAK C, SQ AND AND DSP LEAD MODELS DSP LEADSP910077/S015 VENTAK PRX AICD GUIDANT CORP. ADDITION OF A SUB 05/15/96 MODELS, PRX II ST. PAUL, MN POPULATION TO THE AICD MODELS, PRX 55112 INDICATIONS FOR USE III AICD MODELS, FOR VENTAK PRX, MINI AICD MODELS, PRX II, PRX III, MINI HC AICD MINI AICD, MINI HC MODELS, AND MINI AICD, AND MINI II II AICD MODELS AICD LEADS P930012/S003 PROGRESSIVE PROGRESSIVE APPROVAL FOR THE PAS 05/22/96 ANGIOPLASTY ANGIOPLASTY SYSTEMS CHAMPION PTCA SYSTEMS CHAMPION MENLO PARK, CA CATHETERS PTCA CORONARY 94025 DILATATION CATHETERP930035/S005 VENTAK P2 AICD GUIDANT, CORP. ADD PATIENT GROUP 05/15/96 MODEL 1625 AND ST PAUL, MN TO THE INDICATIONS VENTAK P3 AICD 55112-5798 FOR USE MODELS 1630 AND 1635 P940007/S001 MODEL 127, PHARMACIA, INC. APPROVAL FOR TIER B05/20/96 PLIOLENS DUBLIN, OH POSTERIOR CHAMBER ULTRAVIOLET- 43216 INTRAOCULAR LENS ABSORBING SILICONE MODEL 127 AS A POSTERIOR CHAMBER PATIENT LENS INTRAOCULAR LENS ***ORIGINAL VETERINARY NADAs***140-999 DOMITOR DOGS ORION MEDETOMIDINE 19-MAR-96 (LIQUID SOLUTION) TURKU, FINLAND HYDROCHLORIDE 1.0MG/ML140-994 TOLAZINE HORSES LLOYD TOLAZINE 19-APR-96 (LIQUID SOLUTION) SHENANDOAH, IA HYDROCHLORIDE 100MG/ML 140-919 STENOROL TURKEYS HOECHST ROUSSEL HALOFUGINONE 09-MAY-96 BMD AGR VET HYDROBROMIDE (TYPE A SOMERVILLE, NJ 2.72GM/LB MEDICATED ARTICLES) 08876 BACITRACIN METHYLENE DISALICYLATE 30, 50AND 60GM/LB140-918 STENOROL GROWING HOECHST ROUSSEL HALOFUGINONE 16-MAY-96 FLAVOMYCIN TURKEYS AGR VET HYDROBROMIDE (TYPE A SOMERVILLE, NJ 2.72GM/LB MEDICATED ARTICLES) 08876 BAMBERMYCINS 4 AND10GM/LB ***ORIGINAL ABBREVIATED VETERINARY NADAs*** THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR MAY 1996. ***SUPPLEMENTAL VETERINARY NADAs***006-891 SUL-Q-NOX CATTLE, ID RUSSELL SULFAQUINOXALINE 06-MAR-96 (LIQUID) CALVES, LONGMONT, CO SODIUM CHICKENS, 80501 34% TURKEYS095-735 RUMENSIN PASTURE ELANCO AN HLTH MONENSIN15-MAR-96 (TYPE A ARTICLE) CATTLE GREENFIELD, IN 80GM/LB 46140118-509 PASTURE GAINER PASTURE FARMLAND IND MONENSIN15-MAR-96 BLOCK-37 R350 CATTLE KANSAS CITY, MO 350GM/TON (MEDICATED FREE- 64116 CHOICE PROTEIN- MINERAL BLOCK)115-581 MOORMAN MINTRATE PASTURE MOORMAN MONENSIN15-MAR-96 BLONDE BLOCK CATTLE QUINCY, IL 300GM/TON (MEDICATED FREE- 62305 CHOICE PROTEIN BLOCK)101-862 GARASOL CHICKENS, SCHERING PLOUGH GENTAMICIN SULFATE28-MAR-96 (INJECTABLE) TURKEYS AN HLTH 50 AND100MG/ML KENILWORTH, NJ 07033
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