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FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 18 Number (10) October 1995
Center for Drug Evaluation Center for Devices and
and Research Radiological Health
*George R. Scott (301) 443-3910 Julie Stuart (301) 594-2186
Center for Biologics Center for Veterinary Medicine
Evaluation and Research
Norman Turner (301) 827-3503
Roger Eastep (301) 594-1623
*To whom general inquiries should be directed.
This report is compiled by the Division of Drug Information Resources, OM, CDER.
It is available by subscription from the National Technical Information Service,
Springfield, VA 22161.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE
NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S)
APPROVAL DATE (DOSAGE FORM) STRENGTH(S)
(CLASSIFICATION) CLASSIFICATION(S)
***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
19-658 CLARITIN SCHERING LORATADINE
20-SEP-95 (TABLET) KENILWORTH, NJ 10MG
(SUPPL-003) 07033 (NEW INDICATION --
IDIOPATHIC CHRONIC
URTICARIA)
20-498 CASODEX ZENECA BICALUTAMIDE
04-OCT-95 (TABLET) WILMINGTON, DE 50MG
(1 S, E*, H**) 19897 (ANTIANDROGEN)
[USE IN COMBINATION
THERAPY WITH A
LUTEINIZING-HORMONE
RELEASING HORMONE
(LHRH) ANALOGUE FOR
THE TREATMENT
OF ADVANCED PROSTATE
CANCER]
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
05-OCT-95 (CAPSULE, WAYNE, PA 10MG
(SUPPL-023) DELAYED RELEASE 19087 (NEW STRENGTH)
PELLETS)
50-680 CLEOCIN UPJOHN CLINDAMYCIN PHOSPHATE
05-OCT-95 (CREAM) KALAMAZOO, MI EQ 2% BASE
(SUPPL-001) 49001 (NEW INDICATION --
USE IN PREGNANT WOMEN
DURING THE SECOND
TRIMESTER)
E* - Drug for Severely Debilitating/Life Threatening Illness.
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)
20-429 ORUDIS KT WHITEHALL ROBINS KETOPROFEN
06-OCT-95 (TABLET) MADISON, NJ 12.5MG
(3 S) 07940 (NONSTEROIDAL
ANTI-INFLAMMATORY)
[PAIN RELIEVER/
FEVER REDUCER]
(OTC)
20-499 ACTRON BAYER KETOPROFEN
06-OCT-95 (TABLET) WEST HAVEN, CT 12.5MG
(3 S) 06516 (NONSTEROIDAL
ANTI-INFLAMMATORY)
[PAIN RELIEVER/
FEVER REDUCER]
(OTC)
16-608 TEGRETOL CIBA CARBAMAZEPINE
11-OCT-95 (TABLET) SUMMIT, NJ 200MG
(SUPPL-059) 07901 (NEW PATIENT POPULATION --
USE IN CHILDREN UNDER THE
AGE OF SIX FOR THE
TREATMENT OF GENERALIZED
TONIC CLONIC AND/OR PARTIAL
SEIZURES)
18-281 TEGRETOL CIBA CARBAMAZEPINE
11-OCT-95 (TABLET, CHEWABLE) SUMMIT, NJ 100MG
(SUPPL-010) 07901 (NEW PATIENT POPULATION --
USE IN CHILDREN UNDER THE
AGE OF SIX FOR THE
TREATMENT OF GENERALIZED
TONIC CLONIC AND/OR PARTIAL
SEIZURES)
18-927 TEGRETOL CIBA CARBAMAZEPINE
11-OCT-95 (SUSPENSION) SUMMIT, NJ 100MG/5ML
(SUPPL-018) 07901 (NEW PATIENT POPULATION --
USE IN CHILDREN UNDER THE
AGE OF SIX FOR THE
TREATMENT OF GENERALIZED
TONIC CLONIC AND/OR PARTIAL
SEIZURES)
50-721 BIAXIN ABBOTT CLARITHROMYCIN
12-OCT-95 (TABLET) ABBOTT PARK, IL 250MG
(6 P) 60064 500MG
(NEW INDICATION --
PROPHYLAXIS OF DISSEMINATED
MYCOBACTERIUM AVIUM COMPLEX
(MAC) INFECTIONS IN HIV
INFECTED PATIENTS)
50-710 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE
19-OCT-95 (POWDER NEW YORK, NY EQ 100MG BASE/5ML
(3 S) FOR RECONSTITUTION) 10017 EQ 200MG BASE/5ML
(ANTIBIOTIC, MACROLIDE)
[TREATMENT OF PEDIATRIC
PATIENTS WITH ACUTE OTITIS
MEDIA AND STREPTOCOCCAL
PHARYNGITIS/TONSILLITIS)
20-393 ATROVENT BOEHRINGER INGELHEIM IPRATROPIUM BROMIDE
20-OCT-95 (SPRAY, METERED) RIDGEFIELD, CT 0.021MG/INH
(3 S) 06877 (ANTICHOLINERGIC)
[SYMPTOMATIC RELIEF OF
RHINORRHEA ASSOCIATED WITH
ALLERGIC AND NONALLERGIC
PERENNIAL RHINITIS IN
ADULTS CHILDREN AGE 12
YEARS AND OLDER]
20-394 ATROVENT BOEHRINGER INGELHEIM IPRATROPIUM BROMIDE
20-OCT-95 (SPRAY, METERED) RIDGEFIELD, CT 0.042MG/INH
(3 S) 06877 (ANTICHOLINERGIC)
[SYMPTOMATIC RELIEF OF
RHINORRHEA ASSOCIATED WITH
THE COMMON COLD FOR ADULTS
AND CHILDREN AGE 12 YEARS
AND OLDER]
20-147 TRAVASOL 4.25% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 4.25%
(5 S) W/ELECTROLYTES IN 60073 DEXTROSE
DEXTROSE 25% 25GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 4.25% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 4.25%
(5 S) W/ELECTROLYTES IN 60073 DEXTROSE
DEXTROSE 20% 20GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 4.25% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 4.25%
(5 S) W/ELECTROLYTES IN 60073 DEXTROSE
DEXTROSE 15% 15GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 4.25% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 4.25%
(5 S) W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 10% 10GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 4.25% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 4.25%
(5 S) W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 5% 5GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 2.75% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 2.75%
(5 S) W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 25% 25GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 2.75% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 2.75%
(5 S) W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 20% 20GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 2.75% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 2.75%
(5 S) W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 15% 15GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 2.75% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 2.75%
(5 S) W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 10% 10GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-147 TRAVASOL 2.75% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 2.75%
(5 S) W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 5% 5GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE REPLENISHER)
20-177 TRAVASOL 3.5% BAXTER AMINO ACIDS
23-OCT-95 SULFITE FREE ROUND LAKE, IL 3.5%
(5 S) W/ELECTROLYTES 60073 MAGNESIUM CHLORIDE
IN PLASTIC CONTAINER 51MG/100ML
(INJECTABLE) POTASSIUM PHOSPHATE,
DIBASIC
131MG/100ML
SODIUM ACETATE
218MG/100ML
SODIUM CHLORIDE
35MG/100ML
(NUTRIENT AND ELECTROLYTE
REPLENISHER)
20-608 OMNIPAQUE 240 NYCOMED IOHEXOL
24-OCT-95 (INJECTABLE) NEW YORK, NY 51.8%
(5 S) 10016 (DIAGNOSTIC RADIOPAQUE)
20-608 OMNIPAQUE 300 NYCOMED IOHEXOL
24-OCT-95 (INJECTABLE) NEW YORK, NY 64.7%
(5 S) 10016 (DIAGNOSTIC RADIOPAQUE)
20-608 OMNIPAQUE 350 NYCOMED IOHEXOL
24-OCT-95 (INJECTABLE) NEW YORK, NY 75.5%
(5 S) 10016 (DIAGNOSTIC RADIOPAQUE)
20-173 TRAVASOL 5.5% BAXTER AMINO ACIDS
27-OCT-95 SULFITE FREE ROUND LAKE, IL 5.5%
(5 S) W/ELECTROLYTES 60073 MAGNESIUM CHLORIDE
IN PLASTIC CONTAINER 102MG/100ML
(INJECTABLE) POTASSIUM PHOSPHATE,
DIBASIC
522MG/100ML
SODIUM ACETATE
431MG/100ML
SODIUM CHLORIDE
224MG/100ML
(NUTRIENT AND ELECTROLYTE
REPLENISHER)
20-173 TRAVASOL 8.5% BAXTER AMINO ACIDS
27-OCT-95 SULFITE FREE ROUND LAKE, IL 8.5%
(5 S) W/ELECTROLYTES 60073 MAGNESIUM CHLORIDE
IN PLASTIC CONTAINER 102MG/100ML
(INJECTABLE) POTASSIUM PHOSPHATE,
DIBASIC
522MG/100ML
SODIUM ACETATE
594MG/100ML
SODIUM CHLORIDE
154MG/100ML
NUTRIENT AND ELECTROLYTE
REPLENISHER)
20-460 CYTOVENE SYNTEX GANCICLOVIR
27-OCT-95 (CAPSULE) PALO ALTO, CA 250MG
(SUPPL-005) 94304 (NEW INDICATION --
PREVENTION OF
CYTOMEGALOVIRUS (CMV)
DISEASE IN INDIVIDUALS
WITH HIV INFECTION AT RISK
FOR DEVELOPING CMV DISEASE)
20-195 FENTANYL ANESTA FENTANYL CITRATE
30-OCT-95 (TROCHE/LOZENGE) SALT LAKE CITY, UT EQ 0.1MG BASE
(SUPPL-001) 84103 (NEW STRENGTH)
***ERRATA***
20-398 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE
15-SEP-95 (SUSPENSION) TITUSVILLE, NJ EQ 1MG BASE/ML
(3 S***) 08560 (UPPER GI TRACT MOTILITY
STIMULATOR)
20-444 FLOLAN BURROUGHS WELLCOME EPOPROSTENOL SODIUM
20-SEP-95 (INJECTABLE) RES TRIANGLE PK, NC EQ 0.5MG BASE/VIAL
(1 P,V****) 27709 EQ 1.5MG BASE/VIAL
(PROSTAGLANDIN)
[LONG-TERM INTRAVENOUS
TREATMENT OF PRIMARY
PULMONARY HYPERTENSION IN
NYHA CLASS III AND CLASS IV
ADULT PATIENTS]
*** - Previously Published incorrectly as (1 S)
**** - Previously Published incorrectly as (1 P)
V**** - Designated Orphan Drug
***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.
19-672 EFIDAC 24 ALZA BROMPHENIRAMINE MALEATE
20-OCT-95 PSEUDOEPHEDRINE/ PALO ALTO, CA 16MG
BROMPHENIRAMINE 94303 PSEUDOEPHEDRINE
(TABLET, HYDROCHLORIDE
EXTENDED RELEASE) 240MG
(ANTIHISTAMINE/DECONGESTANT)
(OTC)
20-520 ZANTAC 75 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE
23-OCT-95 (TABLET) RES TRIANGLE PK, NC EQ 75MG BASE
27709 (HISTAMINE H-2
RECEPTOR ANTAGONIST)
(OTC)
20-298 ZYLOPRIM BURROUGHS WELLC ALLOPURINOL SODIUM
25-OCT-95 (INJECTABLE) RES TRIANGLE PK, NC EQ 500MG BASE/VIAL
27709 (XANTHINE OXIDASE
INHIBITOR)
20-449 TAXOTERE RHONE POULENC DOCETAXEL
27-OCT-95 (INJECTABLE) COLLEGEVILLE, PA 40MG/ML
19426 (ANTINEOPLASTIC)
20-506 TIAMATE MERCK DILTIAZEM MALATE
31-OCT-95 (TABLET, WEST POINT, PA EQ 120MG
EXTENDED RELEASE) 19486 HYDROCHLORIDE
EQ 180MG HYDROCHLORIDE
EQ 240MG HYDROCHLORIDE
(CALCIUM ION INFLUX
INHIBITOR)
20-507 TECZEM MERCK DILTIAZEM MALATE
31-OCT-95 (TABLET, WEST POINT, PA EQ 180MG
EXTENDED RELEASE) 19486 HYDROCHLORIDE
ENALAPRIL MALEATE
5MG
(CALCIUM ION INFLUX
INHIBITOR/ANGIOTENSIN
CONVERTING ENZYME
INHIBITOR)
***ORIGINAL ABBREVIATED NDAs***
74-478 METOCLOPRAMIDE HCL INVAMED METOCLOPRAMIDE HYDROCHLORIDE
05-OCT-95 (TABLET) DAYTON, NJ EQ 5MG BASE
08810 EQ 10MG BASE
(UPPER GI TRACT MOTILITY
STIMULATOR)
74-311* TRIFLURIDINE STERIS TRIFLURIDINE
06-OCT-95 (SOLUTION/DROPS) PHOENIX, AZ 1%
85043 (ANTIVIRAL)
40-008 HEPARIN SODIUM MARSAM HEPARIN SODIUM
10-OCT-95 (INJECTABLE) CHERRY HILL, NJ 1,000 UNITS/ML
08034 (ANTICOAGULANT)
74-145* GUANFACINE HCL WATSON LABS GUANFACINE HYDROCHLORIDE
17-OCT-95 (TABLET) CORONA, CA EQ 1MG BASE
91720 EQ 2MG BASE
(ANTIHYPERTENSIVE)
74-007 ACEBUTOLOL HCL WATSON LABS ACEBUTOLOL HYDROCHLORIDE
18-OCT-95 (CAPSULE) CORONA, CA EQ 200MG BASE
91720 EQ 400MG BASE
(BETA ADRENERGIC BLOCKER)
74-445 TRIAZOLAM CHELSEA TRIAZOLAM
20-OCT-95 (TABLET) CINCINNATI, OH 0.125MG
45215 0.25MG
(SEDATIVE/HYPNOTIC)
63-277 DOXORUBICIN HCL FUJISAWA USA DOXORUBICIN HYDROCHLORIDE
26-OCT-95 (INJECTABLE) DEERFIELD, IL 2MG/ML
60015 (ANTIBIOTIC, ANTITUMOR)
40-108 ACETAZOLAMIDE SODIUM SANOFI WINTHROP ACETAZOLAMIDE SODIUM
30-OCT-95 (INJECTABLE) NEW YORK, NY EQ 500MG BASE/VIAL
10016 (CARBONIC ANHYDRASE
INHIBITOR)
* - First Time Product Available Generically
64-055 NEOMYCIN SULFATE AND BAUSCH AND LOMB DEXAMETHASONE SODIUM
30-OCT-95 DEXAMETHASONE SODIUM TAMPA, FL PHOSPHATE
PHOSPHATE 33637 EQ 0.1% PHOSPHATE
(SOLUTION/DROPS) NEOMYCIN SULFATE
EQ 3.5MG BASE/ML
(ANTIBIOTIC/STEROID)
64-064 NEOMYCIN AND BAUSCH AND LOMB BACITRACIN ZINC
30-OCT-95 POLYMYXIN B SULFATES TAMPA, FL 400 UNITS/GM
AND BACITRACIN ZINC 33637 NEOMYCIN SULFATE
(OINTMENT) EQ 3.5MG BASE/GM
POLYMYXIN B SULFATE
EQ 10,000 UNITS/GM
(ANTIBIOTIC)
64-068 NEOMYCIN AND BAUSCH AND LOMB BACITRACIN ZINC
30-OCT-95 POLYMYXIN B SULFATES, TAMPA, FL 400 UNITS/GM
BACITRACIN ZINC AND 33637 HYDROCORTISONE
HYDROCORTISONE 1%
(OINTMENT) NEOMYCIN SULFATE
EQ 3.5MG BASE/GM
POLYMYXIN B SULFATE
10,000 UNITS/GM
(ANTIBIOTIC, STEROID)
89-047 SULF-15 CIBA VISION SULFACETAMIDE SODIUM
31-OCT-95 (SOLUTION/DROPS) DULUTH, GA 15%
30155 (ANTIBACTERIAL)
***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 APPROVAL
FOR OCTOBER 1995.
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
18-482 PROCARDIA PFIZER LABS NIFEDIPINE
04-OCT-95 (CAPSULE) NEW YORK, NY 10MG
10017 20MG
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE)
19-386 BREVIBLOC OHMEDA PHARM ESMOLOL HYDROCHLORIDE
04-OCT-95 (INJECTABLE) LIBERTY CORNER, NJ 10MG/ML
07938 250MG/ML
(LABELING REVISION --
OVERDOSAGE)
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
05-OCT-95 (TABLET) WAYNE, PA 10MG
19087 20MG
(LABELING REVISION --
DESCRIPTION; HOW SUPPLIED)
50-680 CLEOCIN UPJOHN CLINDAMYCIN PHOSPHATE
05-OCT-95 (CREAM) KALAMAZOO, MI EQ 2% BASE
49001 (LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
19-436 PRIMACOR SANOFI WINTHROP MILRINONE LACTATE
06-OCT-95 (INJECTABLE) NEW YORK, NY EQ 1MG BASE/ML
10016 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
ADVERSE REACTIONS)
16-608 TEGRETOL CIBA CARBAMAZEPINE
11-OCT-95 (TABLET) SUMMIT, NJ 200MG
07901 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
18-281 TEGRETOL CIBA CARBAMAZEPINE
11-OCT-95 (TABLET, CHEWABLE) SUMMIT, NJ 100MG
07901 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
18-927 TEGRETOL CIBA CARBAMAZEPINE
11-OCT-95 (SUSPENSION) SUMMIT, NJ 100MG/5ML
07901 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
20-560 FOSAMAX MERCK ALENDRONATE SODIUM
16-OCT-95 (TABLET) WEST POINT, PA EQ 10MG BASE
19486 EQ 40MG BASE
(LABELING REVISION --
HOW SUPPLIED)
18-972 CORDARONE WYETH AYERST AMIODARONE HYDROCHLORIDE
18-OCT-95 (TABLET) RADNOR, PA 200MG
19087 (LABELING REVISION --
PRECAUTIONS)
20-377 CORDARONE WYETH AYERST AMIODARONE HYDROCHLORIDE
18-OCT-95 (INJECTABLE) RADNOR, PA 50MG/ML
19087 (LABELING REVISION --
DOSAGE AND ADMINISTRATION)
20-406 PREVACID TAP HOLDINGS LANSOPRAZOLE
18-OCT-95 (CAPSULE, DEERFIELD, IL 15MG
DELAYED RELEASE 60015 30MG
GRANULES) (LABELING REVISION --
DESCRIPTION;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
20-309 MAGNESIUM SULFATE ABBOTT MAGNESIUM SULFATE
23-OCT-95 (INJECTABLE) ABBOTT PARK, IL 4GM/100ML
60064 80MG/ML
(LABELING REVISION --
CLINICAL PHARMACOLOGY)
50-558 ZINACEF GLAXO CEFUROXIME SODIUM
23-OCT-95 (INJECTABLE) RES TRIANGLE PK, NC EQ 750MG BASE/VIAL
27709 EQ 1.5GM BASE/VIAL
EQ 7.5GM BASE/VIAL
(LABELING REVISION --
PRECAUTIONS)
50-643 ZINACEF GLAXO CEFUROXIME SODIUM
23-OCT-95 (INJECTABLE) RES TRIANGLE PK, NC EQ 15MG BASE/ML
27709 EQ 30MG BASE/ML
(LABELING REVISION --
PRECAUTIONS)
20-073 ROMAZICON ROCHE FLUMAZENIL
24-OCT-95 (INJECTABLE) NUTLEY, NJ 0.1MG/ML
07110 (LABELING REVISION --
CHANGE OF TRADE NAME FROM
MAZICON TO ROMAZICON)
16-131 CLOMID HOECHST MARION ROUSSEL CLOMIPHENE CITRATE
25-OCT-95 (TABLET) KANSAS CITY, MO 50MG
64137 (LABELING REVISION --
INDICATIONS AND USAGE;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
19-847 CIPRO BAYER CIPROFLOXACIN
25-OCT-95 (INJECTABLE) WEST HAVEN, CT 10MG/ML
06516 (LABELING REVISION --
CLINICAL PHARMACOLOGY)
19-857 CIPRO IN DEXTROSE 5% BAYER CIPROFLOXACIN
25-OCT-95 IN PLASTIC CONTAINER WEST HAVEN, CT 200MG/100ML
(INJECTABLE) 06516 (LABELING REVISION --
CLINICAL PHARMACOLOGY)
19-858* CIPRO IN SODIUM BAYER CIPROFLOXACIN
25-OCT-95 CHLORIDE 0.9% WEST HAVEN, CT 200MG/100ML
IN PLASTIC CONTAINER 06516 (LABELING REVISION --
(INJECTABLE) CLINICAL PHARMACOLOGY)
20-460 CYTOVENE SYNTEX GANCICLOVIR
27-OCT-95 (CAPSULE) PALO ALTO, CA 250MG
94304 (LABELING REVISION --
BOXED WARNING;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE EVENTS;
DOSAGE AND ADMINISTRATION)
19-353 ALFENTA JANSSEN ALFENTANIL HYDROCHLORIDE
30-OCT-95 (INJECTABLE) PISCATAWAY, NJ EQ 0.5MG BASE/ML
08854 (LABELING REVISION --
CONTRAINDICATIONS;
ADVERSE REACTIONS)
* - Not Marketed At This Time
20-195 FENTANYL ANESTA FENTANYL CITRATE
30-OCT-95 (TROCHE/LOZENGE) SALT LAKE CITY, UT EQ 0.1MG BASE
84103 EQ 0.2MG BASE
EQ 0.3MG BASE
EQ 0.4MG BASE
(LABELING REVISION --
DESCRIPTION;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
18-874 CALCIJEX ABBOTT CALCITRIOL
31-OCT-95 (INJECTABLE) ABBOTT PARK, IL 0.001MG/ML
60664 0.002MG/ML
(LABELING REVISION --
DESCRIPTION)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
0315 NONE CENTRAL CALIFORNIA PLATELETS
25-OCT-95 (INJECTABLE) BLOOD CTR (B)
FRESNO, CA
93706
0740 NONE ASHFORD BLOOD BANK RED BLOOD CELLS
25-OCT-95 (INJECTABLE) SANTURCE, PR (B)
00907
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950050 MULTIPLE IZON BUSINESS PRODS HIV ORAL SPECIMEN &
18-OCT-95 (IZON HIV ORAL NEW YORK, NY URINE COLLECTION KIT
SPECIMEN & URINE 10994 (C)
COLLECTION KIT)
BK940064 RED BLOOD CELL & HAEMONETICS CORP APHERESIS COLLECTION SET
23-OCT-95 PLASMA COLLECTION BRAINTREE, MA (C)
SET FOR MCS PLUS 02184
(C) Substantially Equivalent
***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
P930034 SVS APEX SUMMIT TECHNOLOGY, INC. INDICATED FOR A 6.0MM
10/20/95 (FORMERLY OMNIMED) WALTHAM, MA ABLATION ZONE - MYOPIC
EXCIMER LASER 02154 PHOTOREFRACTIVE
SYSTEM FOR KERATECTOMY (PRK)
PHOTOREFRACTIVE FOR PATIENTS WHO
KERATECTOMY (PRK) MEET SPECIFIC CRITERIA
***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
N18073/S024 SOFT MATE DAILY PILKINGTON BARNES HIND ALTERNATE
10/31/95 CLEANING SOLUTION, SUNNYVALE, CA STERILIZATION
SOFT MATE PS* 94086-5200 FACILITY
DAILY CLEANING (CORONA, CA)
SOLUTION AND SOFT
MATE HANDS OFF
OFF DAILY CLEANER
N18078/S049 SOFT MATE PILKINGTON BARNES HIND ALTERNATE
10/31/95 SALINE SOLUTION SUNNYVALE, CA STERILIZATION
94086-5200 FACILITY
(CORONA, CA)
P800018/S020 SOFT MATE PS PILKINGTON BARNES HIND ALTERNATE
10/31/95 COMFORT DROPS, SUNNYVALE, CA STERILIZATION
SOFT MATE 94086-5200 FACILITY
COMFORT DROPS, (CORONA, CA)
AND BARNES-HIND
GAS PERMEABLE
COMFORT DROPS
P820003/S070 MODEL 5348 MEDTRONIC, INC. NEW MODELS:
10/31/95 TEMPORARY PACEMAKER, MINNEAPOLIS, MN VITATRON MEP3000
VITATRON MEP3000 55432-3576 EXTERNAL PACEMAKER
EXTERNAL PACEMAKER, MODELS:5832, 5832S,
MODEL 5832, 5832S, 5433A, AND 5433V
5433A, AND 5433V CABLES, AND MODEL 5101
CABLES, AND ADAPTOR
MODEL 5101 ADAPTOR
P820018/S068 AUTIMA/AURORA TELECTRONICS PACING SYSTEMS APPROVAL FOR THE
10/10/95 CARDIAC PACING ENGLEWOOD, CO ADDITION OF A
SYSTEM:REFLEX DDD 80112 POLYAMIDE
MODELS 8224/8223E INSULATOR TO THE
& REFLEX TELEMETRY COIL
MODELS 8218/8220E
PULSE GENERATORS,
SIMPLEX
MODEL 8232
PULSE GENERATOR
P820040/S032 PURE EYES CIBA VISION, CORP. MODIFICATIONS TO
10/23/95 DISINFECTANT/ DULUTH, GA AOSEPT LENS CUP &
SOAKING SOLUTION 30136-1518 AODISC NEUTRALIZER
AND PURE EYES INCLUDING CHANGES IN
LENS CASE WITH CUP MANUFACTURING
BUILT-IN SITE, CUP MATERIAL,
NEUTRALIZER CUP & DISC DESIGN, &
LABELING CHANGES
P820049/S060 MODELS PC-58NBM ALLERGAN MEDICAL OPTICS TIER A MODIFICATIONS
10/18/95 AND PC-58NBZ, IRVINE, CA OF A PREVIOUSLY
LOW-DIOPTER 92713-9534 APPROVED ALLERGAN
ULTRAVIOLET- MEDICAL OPTICS LENS -
ABSORBING PMMA LENSES WILL BE
POSTERIOR CHAMBER OFFERED IN POWERS
INTRAOCULAR FROM -10.0 TP +5.5
LENSES (IOLS) DIOPTERS
P820075/S006 LAMICEL OSMOTIC MEROCEL CORPORATION APPROVAL FOR A NEW
10/10/95 CERVICAL DILATOR MYSTIC, CT ACCELERATED TESTING
06355-0334 PROTOCOL TO
ESTABLISH THE SHELF
LIFE OF THE PRODUCT
TO 24 MONTHS
P830034/S026 ALCON ALCON LABORATORIES, INC. MULTI-PURPOSE
10/31/95 MULTI-PURPOSE FORT WORTH, TX SOLUTION ID 81573
SOLUTION ID 81573 76134-2099 SOLUTION FOR
CLEANING, RINSING,
DISINFECTING,
AND STORING SOFT
CONTACT LENSES
P830060/S040 CPI MODEL 6888 CARDIAC PACEMAKERS, INC. MODEL 6888 LEAD
10/03/95 LEAD TUNNELER ST. PAUL, MN TUNNELER
55112-5798
P830061/S025 MEDTRONIC CAPSURE MEDTRONIC, INC. CHANGE IN
10/31/95 AND CAPSURE SP MINNEAPOLIS, MN STERILIZATION
PACING LEADS 55432-3576 PROCESS FROM THE USE
OF 12% ETHYLENE
OXIDE (ETO), 88%
CFC, TO 100% ETO
P840001/S032 MEDTRONIC ITREL I MEDTRONIC NEUROLOGICAL ALTERNATE BEAD BLAST
10/17/95 AND II SCS SYSTEMS MINNEAPOLIS, MN FINISH
55440-9087
P840008/S051 DORNIER DORNIER MEDICAL SYSTEMS APPROVAL FOR
10/05/95 LITHOTRIPTER KENNESAW, GA TRANSPORTABLE
COMPACT 30144 VERSION OF THE
TRANSPORTABLE DORNIER LITHOTRIPTER
(DLCT) COMPACT
TRANSPORTABLE (DLCT)
P840008/S052 DORNIER DORNIER MEDICAL SYSTEMS, INC. NEW MODEL
10/05/95 LITHOTRIPTER KENNESAW, GA LITHOTRIPTER
TRANSPORTABLE 30144 INDICATED FOR
FRAGMENTATION
OF 5 TO 25
MILLIMETER
KIDNEY STONES
SUCH AS RENAL
CALYX STONES AND
RENAL PELVIC
STONES
P840040/S049 MEDI-TECH BOSTON SCIENTIFIC, CORP. REVISED LABELING
10/19/95 CORONARY BALLOON NATICK, MA BASED ON FDA LTR
DILATATION CATHETER 01760-1537 OF 1/7/95
P840040/S050 MEDI-TECH BOSTON SCIENTIFIC, CORP. REVISED LABELING
10/19/95 CORONARY BALLOON NATICK, MA
DILATATION CATHETER 01760-1537
P840060/S025 MODEL MC50CD ALCON LABORATORIES, INC. NEW MODEL: MC50CD UV
10/05/95 ULTRAVIOLET- FORT WORTH, TX ABSORBING POSTERIOR
ABSORBING 76134-2099 CHAMBER IOL
POSTERIOR CHAMBER
INTRAOCULAR LENS
P840066/S033 SOFT MATE PILKINGTON BARNES HIND ALTERNATE
10/31/95 CONSEPT CLEANING SUNNYVALE, CA STERILIZATION
AND 94086-5200 FACILITY
DISINFECTING SOLUTION (CORONOA, CA)
P850051/S051 MEDTRONIC PREVAIL MEDTRONIC, INC. APPROVAL FOR THE
10/31/95 PULSE GENERATORS MINNEAPOLIS, MN ADDITION OF THREE
MODELS 8084, 8085, 55432-3576 MODELS OF
AND 8086 AND PULSE GENERATORS TO
MODEL 9885 SOFTWARE THE ACTVITRAX
AND MODEL 9773 CARDIAC PACING
MEMORYMOD SYSTEM
P850089/S032 MEDTRONIC CAPSURE MEDTRONIC, INC. APPROVAL FOR A
10/31/95 AND CAPSURE SP MINNEAPOLIS, MN CHANGE IN THE
PACING LEADS 55432-3576 STERILIZATION
PROCESS FOR THE
USE OF 12% ETHYLENE
OXIDE (ETO), 88%
CFC, TO 100% ETO
P860019/S104 SCIMED PTCA SCIMED LIFE SYSTEMS, INC. INDICATED FOR
10/02/95 CATHETERS SCIMED MAPLE GROVE, MN BALLOON DILATATION
15MM NC BANDIT 55311-1566 OF THE STENOTIC
PTCA CATHETERS PORTION OF A
CORONARY ARTERY OR
BYPASS GRAFT FOR THE
PURPOSE OF IMPROVING
MYOCARDIAL PERFUSION
P860019/S105 SCIMED SCIMED LIFE SYSTEMS, INC. MODIFIED EXPRESS
10/31/95 PERCUTANEOUS MAPLE GROVE, MN PLUS II NEW MODELS:NC
TRANSLUMINAL 55311-1566 EXPRESS PLUS AND
CORONARY ANGIOPLASTY NC EXPRESS PLUS HD
CATHETER SCIMED NC
EXPRESS PLUS AND
NC EXPRESS PLUS HD
PTCA CATHETERS
P860019/S106 SCIMED SCIMED LIFE SYSTEMS, INC. APPROVAL FOR THE
10/31/95 PERCUTANEOUS MAPLE GROVE, MN ADDITION OF EXTRA
TRANSLUMINAL 55311-1566 SILICONE COATING TO
ANGIOPLASTY CATHETER THE POC BANDIT AND
SCIMED POC BANDIT BANDIT PTCA CATHETER
AND BANDIT PTCA LINES
CATHETERS
P860019/S107 SCIMED SCIMED LIFE SYSTEMS, INC. ADDS QUARTER SIZED
10/31/95 PERCUTANEOUS MAPLE GROVE, MN BALLOON DIAMETERS
TRANSLUMINAL 55311-1566 AND ALTERNATE
CORONARY COLORANT IN THE
ANGIOPLASTY BALLOON MANIFOLDS
CATHETER - SCIMED
LEAP EXPRESS PLUS
PTCA CATHETERS
P860061/S010 COMPLETE BRAND ALLERGAN APPROVAL FOR USE OF
10/11/95 WEEKLY ENZYMATIC IRVINE, CA DEVICE (SMALL TABLET
CLEANER 92713-9534 FORMULATION) IN LENS
CASES WITH VOLUMES
RANGING FROM 1.8ML
TO 4ML PER WELL
P870045/S039 ULTRAVIOLET CHIRON VISION, CORP. ALTERNATE
10/11/95 ABSORBING AND IRVINE, CA STERILIZATION CYCLE
NON-ULTRAVIOLET 92718-1903 WITH REVISED
ABSORBING PARAMETERS
POSTERIOR CHAMBER
INTRAOCULAR LENSES
P880065/S002 MANSFIELD AORTIC BOSTON SCIENTIFIC, CORP. APPROVAL FOR A NEW
10/23/95 VALVULOPLASTY NATICK, MA CONTRACT STERILIZER
BALLOON 01760-1537 AND A CHANGE IN THE
DILATATION CATHETERS STERILIZATION
PROCEDURE
P890003/S037 MEDTRONIC MEDTRONIC, INC. REDUCED DEVICE
10/31/95 THERA-I/PRODIGY MINNEAPOLIS, MN SIZE FOR THERA DR
PULSE GENERATORS, 55432-3576 MODEL. NEW TRADE
MODEL 9879 SOFTWARE, NAME: MEDTRONIC
AND MODELS 9759/9772 THERA-I SERIES
MEMORYMODS
P890003/S042 SYNERGYST II MEDTRONIC, INC. MODIFIED SOFTWARE
10/31/95 MODEL 9889E SOFTWARE MINNEAPOLIS, MN DISTRIBUTOR WILL
55432-3576 RELABEL TRIUMPH VR,
ELITE AS PRELUDE DR
AND SYNERGYST II AS
TRIUMPH DR
P890032/S022 CORDIS ORION CORDIS, CORP. ALTERNATE
10/31/95 STEERABLE PTCA MIAMI, FL STERILIZATION SITE
BALLOON CATHETER 33102-5700 (ISOMEDIX
NORTHBOROUGH,
MASSACHUSETTS)
P900039/S008 COLLAGRAFT COLLAGEN, CORP. MODIFICATIONS TO THE
10/30/95 IMPLANT - PALO ALTO, CA PRODUCT LABELING
COLLAGRAFT STRIP 94303 PERTAINING TO
POLYMYOSITIS/
DERMATOMYOSITIS
P900052/S002 PORT-A-CATH SIMS DELTEC, INC. MANUFACTURING
10/13/95 INTRASPINAL ST. PAUL, MN CHANGES:
IMPLANTABLE 55112 STERLIZATION
ACCESS SYSTEM PROCESS, PACKAGING,
AND SHELF-LIFE
DATING
P900060/S007 CARBOMEDICS CARBOMEDICS, INC. APPROVAL TO ADD AN
10/26/95 PROSTHETIC HEART AUSTIN, TX ADDITIONAL
VALVE (CPHV), 78752-1793 STERILIZATION
MODELS A500, R500, PROTOCOL TO THE CPHV
S500, M700, INSTRUMENTATION
AND S700 INSTRUCTIONS FOR USE
P910023/S008 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR CADENCE
10/31/95 THERAPY SUNNYVALE, CA V-112 PULSE
DEFIBRILLATOR SYSTEM 94086-6527 GENERATOR SERIES
(B, C, D, E) WITH
PROGRAMMER SOFTWARE
VERSION 3.3
P910023/S011 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR THE
10/31/95 THERAPY SUNNYVALE, CA PROGRAMMER SOFTWARE
DEFIBRILLATOR SYSTEM 94086-6527 VERSION 4.0 WITH THE
CADENCE MODELS V-100,
V-110 OR V112
IMPLANTABLE
DEFIBRILLATOR
P910031/S002 CATHSCANNER ENDOSONICS, CORP. NEW MODEL FACT
10/03/95 ORACLE MICRO PTCA RANCHO CORDOVA, CA INDICATED FOR USE
CATHETER - FACT 95670 IN STENOTIC PORTION
BALLOON CORONARY CORONARY ARTERY OR
DILATATION CATHETER BYPASS GRAFT
STENOSIS
P910064/S012 REALITY FEMALE WISCONSIN PHARMACAL APPROVAL FOR CHANGES
10/05/95 CONDOM COMPANY, INC. IN THE LABELING "KEY
CHICAGO, IL ELEMENTS"
60611
P910066/S001 ORTHOLOGIC 1000 ORTHOLOGIC, CORP. REVISED LABELING:
10/31/95 BONE GROWTH PHOENIX, AZ SUCCESS RATES
STIMULATOR 85034 OBTAINED FROM PATIENT
REGISTRY
***ORIGINAL VETERINARY NADAs***
THERE ARE NO ORIGINAL VETERINARY NADAs FOR OCTOBER 1995.
***ORIGINAL ABBREVIATED VETERINARY NADAs***
200-126 PHENYLBUTAZONE HORSES PHOENIX SCIENTIFIC PHENYLBUTAZONE
01-SEP-95 (INJECTABLE) ST JOSEPH, MO 200MG/ML
64506
200-124 FLUNIXIN MEGLUMINE HORSES PHOENIX SCIENTIFIC FLUNIXIN MEGLUMINE
25-SEP-95 (INJECTABLE) ST JOSEPH, MO 50MG/ML
64506
***SUPPLEMENTAL VETERINARY NADAs***
096-298 BOVATEC CATTLE, HOFFMANN LA ROCHE LASALOCID SODIUM
07-AUG-95 (PREMIX) NON-VEAL NUTLEY, NJ 68-113GM/TON
CALVES 07110
140-338 NAXCEL CATTLE UPJOHN CEFTIOFUR SODIUM
24-AUG-95 (POWDER) KALAMAZOO, MI 1GM/VIAL
49001 4GM/VIAL
039-417 DECCOX SHEEP RHONE POULENC DECOQUINATE
28-AUG-95 (PREMIX) MONMOUTH JUNCTION, NJ 27.2GM/LB
08852
Date created: October 30, 1996; last updated: June 20, 2005 |
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