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FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 18 Number (8) August 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
20-377 CORDARONE WYETH AYERST AMIODARONE HYDROCHLORIDE
03-AUG-95 (INJECTABLE) PHILADELPHIA, PA 50MG/ML
(3 S, V*) 19101 (ANTIARRHYTHMIC)
[INITIATION OF TREATMENT
AND PROPHYLAXIS OF
FREQUENTLY
RECURRING VENTRICULAR
FIBRILLATION AND
HEMODYNAMICALLY UNSTABLE
VENTRICULAR TACHYCARDIA
IN PATIENTS REFRACTORY
TO OTHER THERAPY]
20-313 MIACALCIN SANDOZ PHARM CALCITONIN, SALMON
17-AUG-95 (SPRAY, METERED) EAST HANOVER, NJ 200IU/INH
(3 S) 07936 (HORMONE)
[TREATMENT OF
POSTMENOPAUSAL
OSTEOPOROSIS IN FEMALES
GREATER THAN 5 YEARS
POSTMENOPAUSE WITH LOW
BONE
MASS RELATIVE TO HEALTHY
PREMENOPAUSAL FEMALES]
20-027 CARDIZEM MARION MERRELL DOW DILTIAZEM HYDROCHLORIDE
18-AUG-95 (INJECTABLE) KANSAS CITY, MO 25MG/VIAL
(SUPPL-006) 64124 (NEW STRENGTH/NEW PRODUCT)
19-901 ALTACE HOECHST ROUSSEL RAMIPRIL
22-AUG-95 (CAPSULE) SOMERVILLE, NJ 1.25MG
(SUPPL-010) 08876 2.5MG
5MG
10MG
(NEW INDICATION --
HEART FAILURE POST
MYOCARDIAL INFARCTION)
V* - Designated Orphan Drug
20-280 GENOTROPIN PHARMACIA SOMATROPIN, BIOSYNTHETIC
24-AUG-95 (INJECTABLE) DUBLIN, OH 1.5MG/VIAL
(5 S) 43017 5.8MG/VIAL
(HUMAN GROWTH HORMONE)
[LONG TERM TREATMENT OF
CHILDREN WHO HAVE GROWTH
FAILURE DUE TO AN
INADEQUATE
SECRETION OF ENDOGENOUS
GROWTH HORMONE]
19-415 METRODIN SERONO LABS UROFOLLITROPIN
29-AUG-95 (INJECTABLE) NORWELL, MA 75 IU/AMP
(SUPPL-013) 02061 (NEW DOSAGE REGIMEN --
FLEXIBLE DOSING SCHEDULE
IN LINE WITH CURRENT
CLINICAL PRACTICE)
20-542 DOPAMINE HCL ABBOTT DOPAMINE HYDROCHLORIDE
30-AUG-95 IN DEXTROSE 5% ABBOTT PARK, IL 1.6MG/ML
(5 S) (INJECTABLE) 60064 (INOTROPIC/VASOPRESSOR)
***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.
20-401 TIAZAC BIOVAIL DILTIAZEM HYDROCHLORIDE
01-AUG-95 (CAPSULE, SCARBOROUGH, ONTARIO 120MG
EXTENDED RELEASE) CANADA 180MG
240MG
300MG
360MG
(CALCIUM ION INFLUX
INHIBITOR)
[HYPERTENSION]
20-465 AZULFIDINE EN-TABS KABI PHARMACIA SULFASALAZINE
02-AUG-95 (TABLET, COLUMBUS, OH 500MG
DELAYED RELEASE) 43216 (ANTI-INFLAMMATORY)
[TREATMENT OF RHEUMATOID
ARTHRITIS]
50-673 CECLOR CD ELI LILLY CEFACLOR
04-AUG-95 (TABLET, INDIANAPOLIS, IN 375MG
EXTENDED RELEASE) 46285 500MG
(ANTIBIOTIC, CEPHEM)
20-458 ZINC ACETATE LEMMON ZINC ACETATE
24-AUG-95 (CAPSULE) KULPSVILLE, PA EQ 25MG ZINC
19443 EQ 50MG ZINC
(MINERAL)
[MAINTENANCE TREATMENT OF
PATIENTS WITH WILSON'S
DISEASE WHO HAVE BEEN
INITIALLY TREATED WITH A
CHELATING AGENT]
20-515 ZOLADEX ZENECA GOSERELIN ACETATE
31-AUG-95 (IMPLANT) WILMINGTON, DE EQ 3.6MG BASE
19850 (LUTEINIZING HORMONE-
RELEASING HORMONE ANALOG)
[PALLIATIVE TREATMENT OF
ADVANCED BREAST CANCER IN
PRE- AND PERIMENOPAUSAL
WOMEN]
***ORIGINAL ABBREVIATED NDAs***
74-303 PENTAMIDINE STERIS PENTAMIDINE ISETHIONATE
17-AUG-95 ISETHIONATE PHOENIX, AZ 300MG/VIAL
(INJECTABLE) 85043 (ANTIPROTOZOAL)
74-476* HYDROXYUREA ROXANE HYDROXYUREA
18-AUG-95 (CAPSULE) COLUMBUS, OH 500MG
43216 (ANTINEOPLASTIC)
74-317* HYDROMORPHONE HCL STERIS HYDROMORPHONE
HYDROCHLORIDE
23-AUG-95 (INJECTABLE) PHOENIX, AZ 10MG/ML
85043 (ANALGESIC)
73-644* PROTRIPTYLINE HCL SIDMAK LABS NJ PROTRIPTYLINE
HYDROCHLORIDE
24-AUG-95 (TABLET) EAST HANOVER, NJ 5MG
07936 (ANTIDEPRESSANT)
73-645* PROTRIPTYLINE HCL SIDMAK LABS NJ PROTRIPTYLINE
HYDROCHLORIDE
24-AUG-95 (TABLET) EAST HANOVER, NJ 10MG
07936 (ANTIDEPRESSANT)
64-082 AMPICILLIN TRIHYDRATE BIOCHEMIE AMPICILLIN/
29-AUG-95 (CAPSULE) KUNDL, AUSTRIA AMPICILLIN TRIHYDRATE
EQ 250MG BASE
EQ 500MG BASE
(ANTIBIOTIC, PENICILLIN)
74-388* GLYBURIDE NOVOPHARM GLYBURIDE
29-AUG-95 (TABLET) SCARBOROUGH, ONTARIO 1.25MG
CANADA 2.5MG
5MG
(BLOOD GLUCOSE REGULATOR)
74-320 ETOPOSIDE ABBOTT ETOPOSIDE
30-AUG-95 (INJECTABLE) ABBOTT PARK, IL 20MG/ML
[VIAL] 60064 (ANTINEOPLASTIC)
* - First Time Product Available Generically
74-351 ETOPOSIDE ABBOTT ETOPOSIDE
30-AUG-95 (INJECTABLE) ABBOTT PARK, IL 20MG/ML
[BULK PACKAGE] 60064 (ANTINEOPLASTIC)
64-093 GENTAMICIN SULFATE ADV REMEDIES GENTAMICIN SULFATE
31-AUG-95 (OINTMENT) SOMERSET, NJ EQ 0.3% BASE
08873 (ANTIBIOTIC,
AMINOGLYCOSIDE)
72-272 DROPERIDOL SANOFI WINTHROP DROPERIDOL
31-AUG-95 (INJECTABLE) NEW YORK, NY 2.5MG/ML
10016 (TRANQUILIZER)
74-304* BETAMETHASONE NMC BETAMETHASONE
DIPROPIONATE
31-AUG-95 DIPROPIONATE BALTIMORE, MD EQ 0.05% BASE
(OINTMENT, AUGMENTED) 21224 (CORTICOSTEROID)
74-334* VECURONIUM BROMIDE STERIS VECURONIUM BROMIDE
31-AUG-95 (INJECTABLE) PHOENIX, AZ 10MG/VIAL
85043 20MG/VIAL
(NONDEPOLARIZING
NEUROMUSCULAR BLOCKER)
74-359* BUTALBITAL, ASPIRIN, WATSON LABS ASPIRIN
31-AUG-95 CAFFEINE, AND CODEINE CORONA, CA 325MG
(CAPSULE) 91720 BUTALBITAL
50MG
CAFFEINE
40MG
CODEINE PHOSPHATE
30MG
(ANALGESIC)
74-456 ALPRAZOLAM CHELSEA ALPRAZOLAM
31-AUG-95 (TABLET) CINCINNATI, OH 0.25MG
45215 0.5MG
1MG
(ANXIOLYTIC)
* - First Time Product Available Generically
74-497 GLIPIZIDE BAKER NORTON GLIPIZIDE
31-AUG-95 (TABLET) MIAMI, FL 5MG
33178 10MG
(BLOOD GLUCOSE REGULATOR)
***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.
74-462 CAPTOPRIL COPLEY PHARMA CAPTOPRIL
24-AUG-95 (TABLET) CANTON, MA 12.5MG
02021 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-505 CAPTOPRIL WESTWARD CAPTOPRIL
31-AUG-95 (TABLET) EATONTOWN, NJ 12.5MG
07724 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
19-766 ZOCOR MERCK SIMVASTATIN
01-AUG-95 (TABLET) WEST POINT, PA 5MG
19486 10MG
20MG
40MG
(LABELING REVISION --
ADVERSE REACTIONS;
HOW SUPPLIED)
17-557 DANOCRINE SANOFI WINTHROP DANAZOL
02-AUG-95 (CAPSULE) NEW YORK, NY 50MG
10016 100MG
200MG
(LABELING REVISION --
DESCRIPTION)
20-182 CARNITOR SIGMA TAU LEVOCARNITINE
07-AUG-95 (INJECTABLE) GAITHERSBURG, MD 200MG/ML
20878 (LABELING REVISION --
DOSAGE AND
ADMINISTRATION)
19-643 MEVACOR MERCK LOVASTATIN
08-AUG-95 (TABLET) WEST POINT, PA 10MG
19486 20MG
40MG
(LABELING REVISION --
WARNINGS; ADVERSE
REACTIONS;
HOW SUPPLIED)
50-445 MINOCIN LEDERLE MINOCYCLINE HYDROCHLORIDE
08-AUG-95 (SUSPENSION) PHILADELPHIA, PA EQ 50MG BASE/5ML
19101 (LABELING REVISION --
ADVERSE REACTIONS)
50-451 MINOCYCLINE LEDERLE MINOCYCLINE HYDROCHLORIDE
08-AUG-95 HYDROCHLORIDE PHILADELPHIA, PA EQ 50MG BASE
(TABLET) 19101 EQ 100MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
50-649 MINOCIN LEDERLE MINOCYCLINE HYDROCHLORIDE
08-AUG-95 (CAPSULE) PHILADELPHIA, PA EQ 50MG BASE
19101 EQ 100MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
18-057 PLATINOL BRISTOL MYERS CISPLATIN
09-AUG-95 (INJECTABLE) EVANSVILLE, IN 10MG/VIAL
47721 50MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
18-057 PLATINOL AQ BRISTOL MYERS CISPLATIN
09-AUG-95 (INJECTABLE) EVANSVILLE, IN 1MG/ML
47721 (LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
19-763 IFEX BRISTOL MYERS SQUIBB IFOSFAMIDE
09-AUG-95 (INJECTABLE) BUFFALO, NY 1GM/VIAL
14213 3GM/VIAL
(LABELING REVISION --
DESCRIPTION; PRECAUTIONS;
HOW SUPPLIED)
20-182 CARNITOR SIGMA TAU LEVOCARNITINE
10-AUG-95 (INJECTABLE) GAITHERSBURG, MD 200MG/ML
20878 (LABELING REVISION --
HOW SUPPLIED)
20-287 FRAGMIN PHARMACIA DALTEPARIN SODIUM
14-AUG-95 (INJECTABLE) COLUMBUS, OH 2500IU/0.2ML
43216 (LABELING REVISION --
ADVERSE REACTIONS)
16-647 QUINAGLUTE BERLEX QUINIDINE GLUCONATE
17-AUG-95 (TABLET, CEDAR KNOLLS, NJ 324MG
EXTENDED RELEASE) 07927 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED;
INFORMATION FOR PATIENTS)
19-957 CUTIVATE GLAXO FLUTICASONE PROPIONATE
17-AUG-95 (OINTMENT) RES TRIANGLE PK, NC 0.005%
27709 (LABELING REVISION --
PRECAUTIONS)
16-968 MIOSTAT ALCON LABS CARBACHOL
18-AUG-95 (SOLUTION) FORT WORTH, TX 0.01%
76134 (LABELING REVISION --
INDICATIONS AND USAGE)
20-213 MIOCHOL E CIBAVISION ACETYLCHOLINE CHLORIDE
18-AUG-95 (SOLUTION) DULUTH, GA 20MG/VIAL
30136 (LABELING REVISION --
HOW SUPPLIED)
20-027 CARDIZEM MARION MERRELL DOW DILTIAZEM HYDROCHLORIDE
18-AUG-95 (INJECTABLE) KANSAS CITY, MO 5MG/ML
64124 25MG/VIAL
(LABELING REVISION --
HOW SUPPLIED)
19-107 PROTROPIN GENENTECH SOMATREM
21-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
19-676 NUTROPIN GENENTECH SOMATROPIN, BIOSYNTHETIC
21-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
19-737 METROGEL GALDERMA METRONIDAZOLE
21-AUG-95 (GEL) FORT WORTH, TX 0.75%
76163 (LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS)
20-154 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
21-AUG-95 (TABLET, CHEWABLE) WALLINGFORD, CT 25MG
06492 50MG
100MG
150MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; ADVERSE
REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION)
20-155 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
21-AUG-95 (POWDER WALLINGFORD, CT 100MG/PACKET
FOR RECONSTITUTION) 06492 167MG/PACKET
250MG/PACKET
375MG/PACKET
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; ADVERSE
REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION)
20-156 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
21-AUG-95 (POWDER WALLINGFORD, CT 10MG/ML
FOR RECONSTITUTION) 06492 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; ADVERSE
REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION)
20-168 NUTROPIN GENENTECH SOMATROPIN, BIOSYNTHETIC
21-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
19-901 ALTACE HOECHST ROUSSEL RAMIPRIL
22-AUG-95 (CAPSULE) SOMERVILLE, NJ 1.25MG
08876 2.5MG
5MG
10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
DOSAGE AND
ADMINISTRATION)
12-193* SER-AP-ES CIBA GEIGY HYDRALAZINE HYDROCHLORIDE
23-AUG-95 (TABLET) SUMMIT, NJ 25MG
07901 HYDROCHLOROTHIAZIDE
15MG
RESERPINE
0.1MG
(LABELING REVISION --
PRECAUTIONS)
* - Permitted
19-676 NUTROPIN GENENTECH SOMATROPIN, BIOSYNTHETIC
25-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
20-168 NUTROPIN GENENTECH SOMATROPIN, BIOSYNTHETIC
25-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
17-989 HEMABATE UPJOHN CARBOPROST TROMETHAMINE
29-AUG-95 (INJECTABLE) KALAMAZOO, MI EQ 0.25MG BASE/ML
49001 (LABELING REVISION --
PRECAUTIONS)
19-415 METRODIN SERONO LABS UROFOLLITROPIN
29-AUG-95 (INJECTABLE) NORWELL, MA 75IU/AMP
02061 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
09-330 LANOXIN BURROUGHS WELLCOME DIGOXIN
30-AUG-95 (INJECTABLE) RES TRIANGLE PK, NC 0.1MG/ML
27709 0.25MG/ML
(LABELING REVISION --
PRECAUTIONS)
13-625 NORINYL 1+50 21-DAY SYNTEX MESTRANOL
30-AUG-95 (TABLET) PALO ALTO, CA 0.05MG
94304 NORETHINDRONE
1MG
(LABELING REVISION --
STD STATEMENT;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
PATIENT PACKAGE INSERT)
16-659 NORINYL 1+50 28-DAY SYNTEX MESTRANOL
30-AUG-95 (TABLET) PALO ALTO, CA 0.05MG
94304 NORETHINDRONE
1MG
(LABELING REVISION --
STD STATEMENT;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
PATIENT PACKAGE INSERT)
16-968 MIOSTAT ALCON LABS CARBACHOL
18-AUG-95 (SOLUTION) FORT WORTH, TX 0.01%
76134 (LABELING REVISION --
INDICATIONS AND USAGE)
20-213 MIOCHOL E CIBAVISION ACETYLCHOLINE CHLORIDE
18-AUG-95 (SOLUTION) DULUTH, GA 20MG/VIAL
30136 (LABELING REVISION --
HOW SUPPLIED)
20-027 CARDIZEM MARION MERRELL DOW DILTIAZEM HYDROCHLORIDE
18-AUG-95 (INJECTABLE) KANSAS CITY, MO 5MG/ML
64124 25MG/VIAL
(LABELING REVISION --
HOW SUPPLIED)
19-107 PROTROPIN GENENTECH SOMATREM
21-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
19-676 NUTROPIN GENENTECH SOMATROPIN, BIOSYNTHETIC
21-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
19-737 METROGEL GALDERMA METRONIDAZOLE
21-AUG-95 (GEL) FORT WORTH, TX 0.75%
76163 (LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS)
20-154 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
21-AUG-95 (TABLET, CHEWABLE) WALLINGFORD, CT 25MG
06492 50MG
100MG
150MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; ADVERSE
REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION)
20-155 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
21-AUG-95 (POWDER WALLINGFORD, CT 100MG/PACKET
FOR RECONSTITUTION) 06492 167MG/PACKET
250MG/PACKET
375MG/PACKET
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; ADVERSE
REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION)
20-156 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
21-AUG-95 (POWDER WALLINGFORD, CT 10MG/ML
FOR RECONSTITUTION) 06492 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; ADVERSE
REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION)
20-168 NUTROPIN GENENTECH SOMATROPIN, BIOSYNTHETIC
21-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
19-901 ALTACE HOECHST ROUSSEL RAMIPRIL
22-AUG-95 (CAPSULE) SOMERVILLE, NJ 1.25MG
08876 2.5MG
5MG
10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
DOSAGE AND
ADMINISTRATION)
12-193* SER-AP-ES CIBA GEIGY HYDRALAZINE HYDROCHLORIDE
23-AUG-95 (TABLET) SUMMIT, NJ 25MG
07901 HYDROCHLOROTHIAZIDE
15MG
RESERPINE
0.1MG
(LABELING REVISION --
PRECAUTIONS)
* - Permitted
19-676 NUTROPIN GENENTECH SOMATROPIN, BIOSYNTHETIC
25-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
20-168 NUTROPIN GENENTECH SOMATROPIN, BIOSYNTHETIC
25-AUG-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
17-989 HEMABATE UPJOHN CARBOPROST TROMETHAMINE
29-AUG-95 (INJECTABLE) KALAMAZOO, MI EQ 0.25MG BASE/ML
49001 (LABELING REVISION --
PRECAUTIONS)
19-415 METRODIN SERONO LABS UROFOLLITROPIN
29-AUG-95 (INJECTABLE) NORWELL, MA 75IU/AMP
02061 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
09-330 LANOXIN BURROUGHS WELLCOME DIGOXIN
30-AUG-95 (INJECTABLE) RES TRIANGLE PK, NC 0.1MG/ML
27709 0.25MG/ML
(LABELING REVISION --
PRECAUTIONS)
13-625 NORINYL 1+50 21-DAY SYNTEX MESTRANOL
30-AUG-95 (TABLET) PALO ALTO, CA 0.05MG
94304 NORETHINDRONE
1MG
(LABELING REVISION --
STD STATEMENT;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
PATIENT PACKAGE INSERT)
16-659 NORINYL 1+50 28-DAY SYNTEX MESTRANOL
30-AUG-95 (TABLET) PALO ALTO, CA 0.05MG
94304 NORETHINDRONE
1MG
(LABELING REVISION --
STD STATEMENT;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
PATIENT PACKAGE INSERT)
1188 NONE LYNCHBURG PLASMA SOURCE PLASMA
09-AUG-95 (INJECTABLE) COLORADO SPRINGS, CO (A,B)
80905
1189 NONE BLOOMINGTON PLASMA SOURCE PLASMA
28-AUG-95 (INJECTABLE) BLOOMINGTON, IL (A,B)
61701
1190 NONE ILLINOIS PLASMA SYS SOURCE PLASMA
29-AUG-95 (INJECTABLE) COLORADO SPRINGS, CO (A,B)
80905
1191 NONE PORTLAND BIOLOGICALS SOURCE PLASMA
29-AUG-95 (INJECTABLE) PORTLAND, ME (A,B)
04102
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950039 TERUMO BLOOD BAG TERUMO MED EMPTY BLOOD BAG
25-AUG-95 W/O ANTICOAGULANT ELKTON, MD (C)
21921
BK950011 VIROCLEAR BLACKHAWK BIOSYS QUALITY CONTROL SERUM
28-AUG-95 SAN RAMON, CA (C)
94583
(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
P930030 HEMOSTAGENE BIOETICA, INC. FOR USE IN
08/15/95 ABSORBABLE COLLAGEN PORTLAND, ME SURGICAL PROCEDURES
HEMOSTATIC SPONGE 04101 (OTHER THAN
NEUROSURGICAL
OPHTHALMIC AND
UROLOGICAL)
AS AN ADJUNCT TO
HEMOSTASIS
***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
N17755/S044 ZIMMER ZIMMER, INC. CHANGES IN BONE
08/11/95 OSTEOBOND WARSAW, IN CEMENT COMPOSITION
COPOLYMER 46581-0708
BONE CEMENT
P800036/S030 INFUSAID INFUSAID, INC. LABELING CHANGE
08/14/95 IMPLANTABLE INFUSION NORWOOD, MA REGARDING
PUMP 02062 CHLOROFLUOROCARBON
(CFC) AND CFC IN
PUMP IS "ESSENTIAL
USE"
P810002/S037 ST. JUDE ST. JUDE MEDICAL, INC. USE OF PROOF TESTING
08/11/95 MEDICAL MECHANICAL ST. PAUL, MN IN THE EVALUATION OF
HEART VALVE 55117 ST. JUDE MEDICAL
MECHANICAL HEART
VALVES CONSTRUCTED
WITH CARBOMEDICS,
INC.
MANUFACTURED
COMPONENTS
P830060/S039 MODEL 0010 GUIDANT, CORP. DESIGN CHANGES TO THE
08/28/95 BIPOLAR ST. PAUL, MN MODEL 0010 LEAD AND
TO
ENDOCARDIAL LEAD 55112-5798 USE A "TRAY-IN-TRAY"
PACKAGING SYSTEM FOR
THE LEAD
P840001/S037 MEDTRONIC MEDTRONIC APPROVAL OF
08/29/95 ITREL 3 SPINAL NEUROLOGICAL MEDTRONIC ITREL 3
CORD STIMULATION MINNEAPOLIS, MN SPINAL CORD
STIMULATION
(SCS) SYSTEM 55440-9087 (SCS) SYSTEM FOR THE
TREATMENT OF CHRONIC
INTRACTABLE PAIN OF
THE
TRUNK AND/OR LIMBS
P840008/S050 DORNIER DORNIER MEDICAL APPROVAL FOR A NEW
08/21/95 LITHOTRIPTER SYSTEMS, INC. MODEL LITHOTRIPTER
KENNESAW, GA INDICATED FOR
30144 FRAGMENTATION OF 5 TO
25 MILLIMETER KIDNEY
STONES SUCH AS RENAL
CALYX AND RENAL
PELVIC
P840024/S046 NUCLEUS 22- COCHLEAR, CORP. APPROVAL FOR USE IN
08/21/95 CHANNEL COCHLEAR ENGLEWOOD, CO AN ADULT EXPANDED
IMPLANT LENSES 80112 POPULATION
P840024/S056 NUCLEUS 22 COCHLEAR, CORP. INTRODUCTION OF A
08/31/95 CHANNEL COCHLEAR ENGLEWOOD, CO DPI TRIGGER OUT CABLE
IMPLANT FOR USE 80112
IN ADULTS
P840024/S057 NUCLEUS 22 COCHLEAR, CORP. MODIFICATION TO THE
08/24/95 CHANNEL COCHLEAR ENGLEWOOD, CO NEGATIVE BATTERY
IMPLANT FOR USE 80112 TERMINAL ON THE
IN ADULTS SPECTRA-22 AND MINI
SPEECH PROCESSORS
P840040/S048 SEQUEL BOSTON SCIENTIFIC, CORP. NEW PTCA CATHETER
08/29/95 CONVERTIBLE NATICK, MA CREATED BY THE
RAPID EXCHANGE 01760-1537 MODIFICATION OF
PTCA CATHETER SYNERGY II PTCA
CATHETER; TRADE NAME
IS SEQUEL CONVERTIBLE
RAPID EXCHANGE PTCA
CATHETER
P840064/S014 DUOVISC ALCON LABORATORIES, INC. MODIFICATION TO THE
08/02/95 VISCOELASTIC SYSTEM FORT WORTH, TX DUOVISC PACKAGE
INSERT
PACKAGE INSERT 76134-2099 TO ALLOW FOR USE OF
BOTH DEVICES IN A
SINGLE OPHTHALMIC
PROCEDURE
P860019/S100 SCIMED LEAP SCIMED LIFE SYSTEMS, INC. NEW PTCA CATHETER
08/17/95 EXPRESS PLUS MAPLE GROVE, MN BASED ON
MODIFICATIONS
PTCA CATHETER 55311-1566 TO THE SCIMED EXPRESS
PLUS II PTCA
CATHETER;
TRADE NAME: SCIMED
LEAP
EXPRESS PLUS PTCA
CATHETER
P860019/S101 SCIMED EXPRESS SCIMED LIFE SYSTEMS, INC. CHANGE THE SCIMED
08/22/95 PLUS II MAPLE GROVE, MN EXPRESS PLUS II PTCA
PERCUTANEOUS 55311-1566 CATHETER'S NAME TO
TRANSLUMINAL POC EXPRESS PLUS AND
CORONARY ANGIOPLASTY MODIFY LABELING
(PTCA) CATHETER
P860019/S103 SCIMED PTCA SCIMED LIFE SYSTEMS, INC. ADDITION OF QUARTER
08/15/95 CATHETERS/SCIMED MAPLE GROVE, MN SIZE BALLOONS TO THE
BANDIT PTCA 55311-1566 SCIMED BANDIT, LONG
CATHETERS BANDIT 30, AND THE
SCIMED LONG BANDIT
40 PTCA CATHETER
LINES
P870045/S036 MODEL SP38UB CHIRON VISION, CORP. APPROVAL FOR
08/11/95 POSTERIOR CHAMBER IRVINE, CA MODEL SP38UB
INTRAOCULAR LENS 92718-1903
P880003/S026 CORDIS PTCA CORDIS, CORP. ALTERNATE
08/04/95 DILATATION MIAMI, FL STERILIZATION SITE
CATHETERS AND 33102-5700 AND ELIMINATION OF
ORION STEERABLE CHLOROFLUOROCARBONS
PTCA BALLOON CATHETER FROM STERILIZATION
PROCESS
P880003/S048 CORDIS PTCA CORDIS, CORP. APPROVAL FOR TITAN
08/14/95 DILATATION MIAMI, FL XL PTCA DILATATION
CATHETER/TITAN 33102-5700 CATHETERS WITH A
XL PTCA USABLE LENGTH OF
DILATATION CATHETERS 155CM
P880038/S030 META II MODEL 1204H TELECTRONICS, INC. TELEMETRY COIL
08/14/95 PULSE GENERATOR/ WASHINGTON, D.C. IMPROVEMENT, SCAMP
META III MODELS 1206, 20036 PROCESSOR MICROCODE
1206E, 1206M MODIFICATION, AND
PULSE GENERATORS SUBSTITUTION OF DOW
SILASTIC MEDICAL
ADHESIVE TYPE A
P880072/S030 MDLS GL55A-OUV, MDR, INC. RESPONSE TO FDA'S
08/24/95 GL55B-OUV, ST. PETERSBURG, FL 28-APR-95 LETTER
PS40D-OUV, 33716 REGARDING MDR'S
PS60C-OUV, 1992 AND 1993
PB61B-OUV, ANNUAL REPORTS AND
PB07C-OUV, AND REQUESTED TIER A
LP57L-OUV APPROVALS
P880072/S034 MODEL PL52B-OUV MDR, INC. TIER A APPROVAL
08/24/95 ULTRAVIOLET- ST. PETERSBURG, FL MODEL PL52B-OUV
ABSORBING 33716
POSTERIOR CHAMBER
INTRAOCULAR
LENS (IOL)
P880072/S035 MODIFIED J & C MDR, INC. TIER A APPROVAL
08/07/95 LOOP MODEL PA36 ST. PETERSBURG, FL MODEL P55OC-OUV
POSTERIOR CHAMBER 33716
INTRAOCULAR LENS
P890003/S040 MEDTRONIC MEDTRONIC, INC. MODEL 9877A
08/15/95 MODEL 9877A MINNEAPOLIS, MN SOFTWARE
DISKETTE
SOFTWARE DISKETTE 55432-3576 WHICH PROVIDES
ELECTROPHYSIOLOGY
STUDY (EPS)
SOFTWARE WITH
BACKUP VENTRICULAR
PACING
P890027/S026 NUCLEUS 22 COCHLEAR, CORP. APPROVAL FOR
08/31/95 CHANNEL COCHLEAR ENGLEWOOD, CO INTRODUCTION OF A
IMPLANT FOR USE 80112 DPI TRIGGER OUT CABLE
IN CHILDREN
P890027/S027 NUCLEUS 22 COCHLEAR, CORP. MODIFICATION TO THE
08/24/95 CHANNEL COCHLEAR ENGLEWOOD, CO NEGATIVE BATTERY
IMPLANT FOR USE 80112 TERMINAL ON THE
IN CHILDREN SPECTRA-22 AND
MINI SPEECH
PROCESSORS
P890032/S018 CORDIS PTCA CORDIS, CORP. ALTERNATE
08/04/95 DILATATION CATHETERS MIAMI, FL STERILIZATION SITE
AND ORION STEERABLE 33102-5700 AND ELIMINATION OF
PTCA BALLOON CATHETER CHLOROFLUOROCARBONS
FROM STERILIZATION
PROCESS
P890043/S027 SIMPSON CORONARY GUIDANT, CORP. REVISED PRODUCT
08/17/95 ATHEROCATH REDWOOD CITY, CA LABELING
MODELS SCA-EX 94063
(ALL SIZES) AND
ATHEROCATH-GTO
(ALL SIZES)
P890047/S007 DUOVISC ALCON LABORATORIES, INC. MODIFICATION TO THE
08/02/95 VISCOELASTIC SYSTEM FORT WORTH, TX DUOVISC PACKAGE
76134-2099 INSERT TO ALLOW FOR
USE OF BOTH DEVICES
IN A SINGLE
OPHTHALMIC
PROCEDURE
P900029/S001 QUICK CARE SYSTEM CIBA VISION, CORP. LABELING CHANGES
08/01/95 DULUTH, GA TO ENHANCE THE
30136-1518 INSTRUCTIONS TO
BETTER
COMMUNICATE PROPER
LENS STORAGE
TIMEFRAMES
P900056/S009 ROTABLATOR HEART TECHNOLOGY, INC. CHANGE IN CONTRACT
08/14/95 ROTATIONAL REDMOND, WA MANUFACTURER LOCATION
ANGIOPLASTY SYSTEM 98052-3376 FOR SEAMED, CORP.,
FROM
BOTHELL, WA TO
REDMOND, WA
P900059/S003 ALBUNEX MOLECULAR BIOSYSTEMS, INC. CHANGE IN
STERILIZATION
08/28/95 ULTRASOUND SAN DIEGO, CA PROCEDURE AND
EQUIPMENT
CONTRAST 92121-2789
MICROSPHERES
P900060/S006 CARBOMEDICS CARBOMEDICS, INC. REPLACEMENT OF THE
08/14/95 PROSTHETIC AUSTIN, TX DEPYROGENATION OVENS
HEART VALVE 78752-1793 USED IN THE
(CPHV) DEPYROGENATION
PROCESS
OF THE CPHV
P900060/S009 CARBOMEDICS CARBOMEDICS, INC. USE OF A MODIFIED
08/14/95 PROSTHETIC AUSTIN, TX VALVE HOLDER USED
HEART VALVE 78752-1793 AS AN ACCESSORY WITH
MODELS:A500, R500,
M700, AND S500
P900061/S008 MODEL 7219D MEDTRONIC, INC. APPROVAL FOR
08/22/95 JEWEL PCD AND MINNEAPOLIS, MN MEDTRONIC, INC.,
MODEL 7202D JEWEL CD 55432-3576 BARRIO MARIANA,
HUMACAO, PUERTO
RICO TO MANUFACTURE
MODEL 7219D JEWEL PCD
AND MODEL 7202D
JEWEL CD
P900061/S011 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR
08/01/95 IMPLANTABLE MINNEAPOLIS, MN TECOTHANE 75D
CARDIOVERTER 55432-3576 POLYURETHANE RESIN
DEFIBRILLATOR IN MEDTRONIC
(TECOTHANE 75D IMPLANTABLE
POLYURETHANE RESIN) CARDIOVERTER
DEFIBRILLATOR
P900061/S012 MODEL 7220 MEDTRONIC, INC. APPROVAL FOR
08/22/95 B/D/E JEWEL MINNEAPOLIS, MN MEDTRONIC, INC.,
PLUS ARRHYTHMIA 55432-3576 PUERTO RICO, TO
CONTROL SYSTEM MANUFACTURE MODEL
7220 B/D/E JEWEL
PLUS ARRHYTHMIA
CONTROL SYSTEM
P900061/S015 MEDTRONIC MEDTRONIC, INC. APPROVAL TO ELIMINATE
08/15/95 DEFIBRILLATION MINNEAPOLIS, MN CFC TO MANUFACTURE
LEADS: MODELS 6921 55432-3576 MODELS 6921 AND
AND 6721 6721 LEADS
EPICARDIAL LEADS
P900061/S016 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR MODEL
08/01/95 5420 PATIENT MINNEAPOLIS, MN 5420 PATIENT CABLE TO
CABLE FOR 55432-3576 BE USED WITH
MEDTRONIC,
IMPLANTABLE INC'S IMPLANTABLE
DEFIBRILLATORS DEFIBRILLATORS
P910073/S007 VENTAK P2 AICD CARDIAC PACEMAKERS, INC. APPROVAL FOR MODELS
08/01/95 WITH ENDOTAK C ST. PAUL, MN 0070, 0072, AND 0074
0070, 0072, AND 55112-5798 LEADS
0074 LEADS
P910073/S017 ENDOTAK LEAD MEDTRONIC, INC. APPROVAL FOR MODEL
08/03/95 SYSTEM MODEL MINNEAPOLIS, MN 6946 LEAD REPAIR KIT
6946 LEAD 55432-3576
REPAIR KIT
P910077/S004 PROGRAM DISK CARDIAC PACEMAKERS, INC. APPROVAL FOR PROGRAM
08/03/95 MODEL 2860 ST. PAUL, MN DISK MODEL 2860
REVISION 11.2 55112-5798 REVISION 11.2
SOFTWARE
SOFTWARE OF OF VENTAK PRX AICD
VENTAK PRX SYSTEM
AICD SYSTEM
P920015/S004 TRANSVENE LEAD MEDTRONIC, INC. APPROVAL FOR
08/14/95 MODELS 6936, MINNEAPOLIS, MN MODIFICATIONS TO THE
6933, AND 6939 55432-3576 TRANSVENE LEAD
TECHNICAL MANUALS
P920015/S006 MEDTRONIC MEDTRONIC, INC. ELIMINATE CFC TO
08/17/95 DEFIBRILLATION MINNEAPOLIS, MN MANUFACTURE THE
LEADS: TRANSVENE 55432-3576 REFERENCED
MODELS 6966, DEFIBRILLATION
6936, 6963, AND LEADS
6933 AND MODELS
6939 AND 6999
PATCH LEADS
P920032/S001 MICRO-PACE PACE MEDICAL, INC. APPROVAL FOR MODELS
08/28/95 MODELS 4570, WALTHAM, MA 4570, 4573, AND 4575
4573, AND 4575 02154
DUAL CHAMBER,
DDD, TEMPORARY
CARDIAC PACEMAKERS
P920047/S002 EPT-1000 CARDIAC EP TECHNOLOGIES, INC. APPROVAL FOR EPT-
08/14/95 ABLATION SYSTEM SUNNYVALE, CA 1000 GRAPHICS
94086 SOFTWARE
P920047/S004 EPT-1000 CARDIAC EP TECHNOLOGIES, INC. APPROVAL FOR
08/14/95 ABLATION SYSTEM SUNNYVALE, CA RELOCATION OF
CONTRACT
94086 MANUFACTURE (SEAMED,
CORP.) WHO
MANUFACTURES
EPT-1000 RF GENERATOR
***ORIGINAL VETERINARY NADAs***
200-144 OXYTETRACYCLINE HCL CHICKENS, RHONE MERIEUX CANADA OXYTETRACYCLINE
26-JUN-95 (POWDER) SWINE, VICTORIAVILLE, QC HYDROCHLORIDE
TURKEYS CANADA 166GM/LB
200-129 ISOFLURANE DOGS, HALOCARBON PRODS ISOFLURANE
29-JUN-95 (SOLUTION) HORSES RIVER RIDGE, NJ 99.9%
07661
200-115 GENTAMEX 100 HORSES MACLEOD PHARMA GENTAMICIN
SULFATE
21-JUL-95 (SOLUTION) FT COLLINS, CO 100MG/ML
80525
***ORIGINAL ABBREVIATED VETERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR AUGUST 1995.
***SUPPLEMENTAL VETERINARY NADAs***
128-409 IVOMEC FOXES MERCK IVERMECTIN
13-JUL-95 (SOLUTION) RAHWAY, NJ 2.7MG/ML
07065
140-974 IVOMEC SWINE MERCK IVERMECTIN
04-AUG-95 (PREMIX) RAHWAY, NJ 0.6%
07065
Date created: October 30, 1996; last updated: June 20, 2005 |
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