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Drug and Device Product Approvals for May 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
16-191 SORBITRATE ZENECA ISOSORBIDE DINITRATE
01-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 DINITRATE
01-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 DINITRATE
01-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 PREDNICARBATE
03-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 PROPIONATE
03-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 HYDROCHLORIDE
07-MAY-96 (TABLET) KING OF PRUSSIA, PA EQ 10MG BASE
(SUPPL-007, 19406 EQ 20MG BASE
009) EQ 30MG BASE
EQ 40MG BASE
(NEW INDICATION --
TREATMENT OF OBSESSIVE
COMPULSIVE DISORDER AND
PANIC DISORDER)
50-674 VANTIN UPJOHN CEFPODOXIME PROXETIL
07-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 PROXETIL
07-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 SODIUM
08-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 SODIUM
08-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 SODIUM
08-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 SODIUM
08-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 NIZATIDINE
09-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 HYDROCHLORIDE
10-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 PHENYLBUTYRATE
13-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 DOCETAXEL
14-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 HYDROCHLORIDE
15-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 HYDROCHLORIDE
15-MAY-96 (CAPSULE) TAMPA, FL 5MG
(3 S) 33607 (ANTIDYSKINETIC)
[ADJUNCTIVE TREATMENT
OF PARKINSON'S DISEASE]
20-007 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE
16-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 HYDROCHLORIDE
16-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 existing
treatments, and the NDA was approved under the provisions of 21 CFR 314
Subpart H)
20-298 ZYLOPRIM GLAXO WELLCOME ALLOPURINOL SODIUM
17-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 PHOSPHATE
17-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 ACETONIDE
20-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 CITRATE
20-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 ACETONIDE
20-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 LIDOCAINE
21-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 OFLOXACIN
22-MAY-96 (SOLUTION) IRVINE, CA 0.3%
(SUPPL-003) 92713 (NEW INDICATION --
TREATMENT OF BACTERIAL
CORNEAL ULCERS)
20-080 IMITREX GLAXO WELLCOME SUMATRIPTAN SUCCINATE
22-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 HYDROCHLORIDE
28-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 ADAPALENE
31-MAY-96 (SOLUTION) FORT WORTH, TX 0.1%
(1 S) 76163 (ANTIACNE)
[TOPICAL TREATMENT OF
ACNE VULGARIS]
20-380 DIFFERIN GALDERMA ADAPALENE
31-MAY-96 (GEL) FORT WORTH, TX 0.1%
(3 S) 76163 (ANTIACNE)
[TOPICAL TREATMENT OF
ACNE VULGARIS]
V* - Designated Orphan Drug
50-725 AUGMENTIN '200' SMITHKLINE BEECHAM AMOXICILLIN
31-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 AMOXICILLIN
31-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 AMOXICILLIN
31-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 AMOXICILLIN
31-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 application
upon the satisfaction of conditions specified in the approvable letter.
Drug products which are the subject of approvable letters may not be legally
marketed until the firm has satisfied the identified deficiencies, as well as
any other requirements that may be imposed by FDA, and has been notified in
writing that the application has been approved. Further information on
approvable NDAs is not subject to Freedom of Information (FOI) release until
applications are approved.
20-509 GEMZAR ELI LILLY GEMCITABINE HYDROCHLORIDE
02-MAY-96 (INJECTABLE) INDIANAPOLIS, IN EQ 1MG BASE/VIAL
46285 (ANTINEOPLASTIC)
20-509 GEMZAR ELI LILLY GEMCITABINE HYDROCHLORIDE
02-MAY-96 (SOLUTION) INDIANAPOLIS, IN EQ 200MG BASE/VIAL
46285 (ANTINEOPLASTIC)
20-410 GASTROMARK ADVANCED MAGNETICS FERUMOXSIL
07-MAY-96 (SUSPENSION) CAMBRIDGE, MA EQ 0.175MG FE/ML
02138 (MRI CONTRAST MEDIA)
20-588 RISPERDAL JANSSEN RISPERIDONE
20-MAY-96 (SOLUTION) TITUSVILLE, NJ 1MG/ML
05860 (ANTIPSYCHOTIC)
50-711 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE
22-MAY-96 (TABLET) GROTON, CT EQ 250MG BASE
06340 (ANTIBIOTIC, MACROLIDE)
20-529 CONDYLOX OCLASSEN PHARM PODOFILOX
23-MAY-96 (GEL) SAN RAFAEL, CA 0.5%
94901 (ANTIMITOTIC)
20-352 IMODIUM A-D MCNEIL CONS PRODS LOPERAMIDE HYDROCHLORIDE
24-MAY-96 (TABLET) FORT WASHINGTON, PA 2MG
19034 (ANTIDIARRHEAL)
(OTC)
20-544 NORPLANT II POPULATION COUNCIL LEVONORGESTREL
31-MAY-96 (IMPLANT) NEW YORK, NY 75MG/IMPLANT
10021 (PROGESTIN)
20-605 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE
31-MAY-96 (SOLUTION) RES TRIANGLE PK, NC EQ 4MG BASE/5ML
27709 (ANTIEMETIC)
***ORIGINAL ABBREVIATED NDAs***
40-079 THIAMINE HCL SANOFI WINTHROP THIAMINE HYDROCHLORIDE
03-MAY-96 (INJECTABLE) NEW YORK, NY 100MG/ML
10016 (VITAMIN)
64-131 AMOXICILLIN APOTHECON AMOXICILLIN
06-MAY-96 (TABLET, CHEWABLE) PRINCETON, NJ 125MG
08543 250MG
(ANTIBIOTIC, PENICILLIN)
74-285 DIFLUNISAL PUREPAC PHARM DIFLUNISAL
07-MAY-96 (TABLET) ELIZABETH, NJ 250MG
07207 500MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-356 CHLORHEXIDINE HI TECH PHARMA CHLORHEXIDINE GLUCONATE
07-MAY-96 GLUCONATE AMITYVILLE, NY 0.12%
(SOLUTION) 11701 (ANTIMICROBIAL)
74-480 NAPROXEN SODIUM WEST WARD PHARM NAPROXEN SODIUM
14-MAY-96 (TABLET) EATONTOWN, NJ EQ 500MG BASE
07724 (NONSTEROIDAL
ANTI-INFLAMMATORY)
40-093 DIGOXIN SANOFI WINTHROP DIGOXIN
16-MAY-96 (INJECTABLE) NEW YORK, NY 0.25MG/ML
10016 (CARDIAC GLYCOSIDE)
74-287 PIROXICAM DANBURY PHARMA PIROXICAM
16-MAY-96 (CAPSULE) DANBURY, CT 10MG
06810 20MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-450 MEXILETINE HCL GENEVA PHARMS MEXILETINE HYDROCHLORIDE
16-MAY-96 (CAPSULE) BROOMFIELD, CO 150MG
80038 200MG
250MG
(ANTIARRHYTHMIC)
64-148 CEFACLOR MARSAM CEFACLOR
23-MAY-96 (CAPSULE) CHERRY HILL, NJ EQ 250MG BASE
08034 EQ 500MG BASE
(ANTIBIOTIC, CEPHEM)
74-386 CAPTOPRIL DANBURY PHARMA CAPTOPRIL
23-MAY-96 (TABLET) DANBURY, CT 12.5MG
06810 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-403 DOPAMINE HCL SANOFI WINTHROP DOPAMINE HYDROCHLORIDE
23-MAY-96 (INJECTABLE) NEW YORK, NY 40MG/ML
10016 (INOTROPIC/VASOPRESSOR)
74-500 MINOXIDIL (FOR MEN) COPLEY PHARM MINOXIDIL
23-MAY-96 (SOLUTION) CANTON, MA 2%
02021 (HAIR GROWTH STIMULANT)
(OTC)
74-594 INDAPAMIDE INVAMED INDAPAMIDE
23-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 drug
application (ANDA) or 505(b)(2) application provisional approval under the
terms of the Drug Price Competition and Patent Term Restoration Act. Such drug
products that are the subjects of tentative approvals may not be legally
marketed until the market exclusivity and/or patent term of the listed
reference drug product has expired. Final approval is also contingent upon
conditions and information available to FDA remaining acceptable. When the
application receives final approval, the product may be legally marketed. The
effective approval date will be listed in this publication and in the "Approved
Drug Products with Therapeutic Equivalence Evaluations" list published by FDA.
Additional information on these applications will become available to the
public when the applications receive final approval.
THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS
FOR MAY 1996.
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
50-521 CECLOR ELI LILLY CEFACLOR
01-MAY-96 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE
46285 EQ 500MG BASE
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
ADVERSE REACTIONS)
50-522 CECLOR ELI LILLY CEFACLOR
01-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 PREDNICARBATE
03-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 PROPIONATE
03-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 METRONIDAZOLE
07-MAY-96 (TABLET) SKOKIE, IL 250MG
60077 500MG
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
20-031 PAXIL SMITHKLINE BEECHAM PAROXETINE HYDROCHLORIDE
07-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 PROXETIL
07-MAY-96 (TABLET) KALAMAZOO, MI EQ 100MG BASE
49001 EQ 200MG BASE
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
50-675 VANTIN UPJOHN CEFPODOXIME PROXETIL
07-MAY-96 (GRANULE, KALAMAZOO, MI EQ 50MG BASE/5ML
FOR RECONSTITUTION) 49001 EQ 100MG BASE/5ML
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
19-510 PECID MERCK FAMOTIDINE
08-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 SODIUM
08-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 SODIUM
08-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 SODIUM
08-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 SODIUM
08-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 SODIUM
08-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 HYDROCHLORIDE
09-MAY-96 (SOLUTION/DROP) ROCHESTER, NY 0.027%
14692 PHENIRAMINE MALEATE
0.315%
(LABELING REVISION --
PATIENT LABELING)
(OTC)
18-873 MEXITIL BOEHRINGER INGELHEIM MEXILETINE HYDROCHLORIDE
10-MAY-96 (CAPSULE) RIDGEFIELD, CT 150MG
06877 200MG
250MG
(LABELING REVISION --
WARNINGS;
ADVERSE REACTIONS;
OVERDOSAGE)
19-614 VERELAN ELAN PHARM VERAPAMIL HYDROCHLORIDE
10-MAY-96 (CAPSULE, GAINESVILLE, GA 120MG
EXTENDED RELEASE) 30504 180MG
240MG
360MG
(LABELING REVISION --
DESCRIPTION;
HOW SUPPLIED)
50-405 KEFLEX ELI LILLY CEPHALEXIN
15-MAY-96 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE
46285 EQ 500MG BASE
(LABELING REVISION --
WARNINGS)
50-406 KEFLEX ELI LILLY CEPHALEXIN
15-MAY-96 (POWDER INDIANAPOLIS, IN EQ 125MG BASE/5ML
FOR RECONSTITUTION) 46285 EQ 250MG BASE/5ML
(LABELING REVISION --
WARNINGS)
50-668 LORABID ELI LILLY LORACARBEF
15-MAY-96 (CAPSULE) INDIANAPOLIS, IN 200MG
46285 400MG
(LABELING REVISION --
HOW SUPPLIED)
20-007 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE
16-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 HYDROCHLORIDE
16-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 ACETONIDE
20-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 CITRATE
20-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 AND
ADMINISTRATION)
50-517 MEFOXIN MSD CEFOXITIN SODIUM
20-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 SODIUM
20-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 SUCCINATE
22-MAY-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 6MG BASE/0.5ML
27709 (LABELING REVISION --
INDICATIONS AND USAGE)
20-083 SPORANOX JANSSEN ITRACONAZOLE
23-MAY-96 (CAPSULE) PISCATAWAY, NJ 100MG
08855 (LABELING REVISION --
BOXED WARNING;
DESCRIPTION;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
08-107 LEUCOVORIN CALCIUM IMMUNEX LEUCOVORIN CALCIUM
24-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 TARTRATE
24-MAY-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 10MG BASE/ML
27709 (LABELING REVISION --
ADVERSE REACTIONS)
20-403 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE
24-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 HYDROCHLORIDE
28-MAY-96 (CAPSULE, KANSAS CITY, MO 60MG
EXTENDED RELEASE) 64134 90MG
120MG
(LABELING REVISION --
WARNINGS;
ADVERSE REACTIONS;
OVERDOSAGE)
19-762 TESTODERM ALZA CORP TESTOSTERONE
28-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 SODIUM
29-MAY-96 (INJECTABLE) PALO ALTO, CA EQ 500MG BASE/VIAL
94304 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
20-249 PEPCID MERCK FAMOTIDINE
31-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 LEUKOCYTES
06-MAY-96 (INJECTABLE) ALLIANCE (B)
JACKSONVILLE, FL
32206
1203 NONE GREEN STREET BIOLGS SOURCE PLASMA
06-MAY-96 (INJECTABLE) LAFAYETTE, LA (A,B)
70506
1204 AVONEX BIOGEN INTERFERON BETA-LA
17-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 SERVICE
14-MAY-96 BRIDGEWATER, NJ (D)
08807
BK960010 NONE BAXTER HLTHCARE CELL WASH SET
22-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 RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIOR
TO PUBLICATION
P910072 SYVA MICRO BEHRING DIAGNOSTICS, USE AN AID IN THE
05/13/96 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 RELIEVE
05/06/96 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
LESIONS
P950001 SELUTE STEROID GUIDANT, CORP. INDICATED FOR CHRONIC
05/08/96 ELUTING ST PAUL, MN PACING AND SENSING
ENDOCARDIAL LEAD 55112-5798 OF THE VENTRICLE
MODELS 4185 AND WHEN USED WITH A
4285 COMPATIBLE PULSE
GENERATOR
P950014 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 AS
05/10/96 SUNNYVALE, CA A TRANSVENOUS
94086-6527 DEFIBRILLATION LEAD
SYSTEM IN PATIENTS
WITH A HISTORY OF
HEMODYNAMICALLY
VENTRICULAR
TACHYARRHYTHMIAS
P950039 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 RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIOR TO
PUBLICATION
N12159/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 HEMOSTAT
P790017/S058 USCI GRUNTZIG C.R. BARD, INC. APPROVAL FOR THE USCI
05/13/96 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
CATHETERS
P790018/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
CELSIUS
P790019/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 CELSIUS
P790025/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 NEW
05/01/96 ANTERIOR CHAMBER CLAREMONT, CA MANUFACTURING
POLYMETHYLMETHA- 91711 PROCESSES OF CLEAR
CRYLATE AND VIOLET HAPTIC
INTRAOCULAR LENSES POLYMETHLYMETHACRYLATE
(PMAA) ONE-PIECE
POSTERIOR CHAMBER LENSES
P810002/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 COMPONENTS
05/30/96 PROGRAMMER ANGLETON, TX
MODEL 522-12 77515
P830055/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 LABEL
P840024/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'S
05/03/96 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 MANUFACTURING
05/01/96 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
UPB300F
P870013/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 LENSES
P870015/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 GENTAMICIN
05/03/96 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
CIRCUITS
P880003/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 BONDING
P890017/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 DEVICE
P890027/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
07059
P900056/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 SYSTEM
P900061/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
MICROPROCESSOR
P910020/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. ADDITIONAL
05/30/96 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 LEADS
P910077/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
CATHETER
P930035/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 B
05/20/96 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/ML
140-994 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, 50
AND 60GM/LB
140-918 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 AND
10GM/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%
TURKEYS
095-735 RUMENSIN PASTURE ELANCO AN HLTH
MONENSIN
15-MAR-96 (TYPE A ARTICLE) CATTLE GREENFIELD, IN
80GM/LB
46140
118-509 PASTURE GAINER PASTURE FARMLAND IND
MONENSIN
15-MAR-96 BLOCK-37 R350 CATTLE KANSAS CITY, MO
350GM/TON
(MEDICATED FREE- 64116
CHOICE PROTEIN-
MINERAL BLOCK)
115-581 MOORMAN MINTRATE PASTURE MOORMAN
MONENSIN
15-MAR-96 BLONDE BLOCK CATTLE QUINCY, IL
300GM/TON
(MEDICATED FREE- 62305
CHOICE PROTEIN BLOCK)
101-862 GARASOL CHICKENS, SCHERING PLOUGH
GENTAMICIN SULFATE
28-MAR-96 (INJECTABLE) TURKEYS AN HLTH 50 AND
100MG/ML
KENILWORTH, NJ
07033
Date created: July 11, 1996; last updated: June 20, 2005 |
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