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FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 19 Number (7) July 1996
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
19-898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM
02-JUL-96 (TABLET) PRINCETON, NJ 10MG
(SUPPL-015) 08543 20MG
40MG
(NEW INDICATION(S) --
FOR HYPERCHOLESTEROLEMIC
PATIENTS WITHOUT CLINICALLY
EVIDENT HEART DISEASE -
REDUCE THE RISK OF
MYOCARDIAL INFARCTION,
REVASCULARIZATION, AND
DEATH DUE TO
CARDIOVASCULAR
CAUSES WITH NO INCREASE
IN
DEATH FROM NON-CARDIO-
VASCULAR CAUSES)
20-616 KADIAN FAULDING MORPHINE SULFATE
03-JUL-96 (CAPSULE, ELIZABETH, NJ 20MG
(3 S) EXTENDED RELEASE) 07207 50MG
100MG
(NARCOTIC ANALGESIC)
[MANAGEMENT OF MODERATE
TO
SEVERE PAIN WHERE
TREATMENT
WITH AN OPIOID ANALGESIC
IS
INDICATED FOR MORE THAN A
FEW DAYS]
20-631 MORPHINE SULFATE MALLINCKRODT MORPHINE SULFATE
03-JUL-96 (INJECTABLE) CHESTERFIELD, MO 1MG/ML
(5 S) 63017 2MG/ML
(NARCOTIC ANALGESIC)
[RELIEF OF MODERATE TO
SEVERE PAIN]
20-630 ULTIVA GLAXO WELLCOME REMIFENTANIL HYDROCHLORIDE
12-JUL-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 1MG BASE/VIAL
(1 S) 27709 EQ 2MG BASE/VIAL
EQ 5MG BASE/VIAL
(ANALGESIC)
[INDUCTION AND
MAINTENANCE
OF GENERAL ANESTHESIA,
AND
FOR CONTINUATION AS AN
ANALGESIC INTO THE
IMMEDIATE POSTOPERATIVE
PERIOD; ALSO PROVIDES AN
ANALGESIC COMPONENT OF
MONITORED ANESTHESIA
CARE]
20-036 AREDIA CIBA GEIGY PAMIDRONATE DISODIUM
16-JUL-96 (INJECTABLE) SUMMIT, NJ 30MG/VIAL
(SUPPL-011) 07901 60MG/VIAL
90MG/VIAL
(NEW INDICATION --
TREATMENT OF OSTEOLYTIC
BONE METASTASES OF BREAST
CANCER)
20-154 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
17-JUL-96 (TABLET, CHEWABLE) WALLINGFORD, CT 25MG
(SUPPL-020) 06492 50MG
100MG
150MG
(MODIFIED INDICATION --
INCLUSION OF NEW CLINICAL
TRIAL DATA)
20-155 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
17-JUL-96 (POWDER FOR WALLINGFORD, CT 100MG/PACKET
(SUPPL-016) RECONSTITUTION) 06492 167MG/PACKET
250MG/PACKET
(MODIFIED INDICATION --
INCLUSION OF NEW CLINICAL
TRIAL DATA)
20-156 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
17-JUL-96 (POWDER FOR WALLINGFORD, CT 10MG/ML
(SUPPL-016) RECONSTITUTION) 06492 (MODIFIED INDICATION --
INCLUSION OF NEW CLINICAL
TRIAL DATA)
50-698 BIAXIN ABBOTT CLARITHROMYCIN
17-JUL-96 (GRANULE, FOR ABBOTT PARK, IL 125MG/5ML
(SUPPL-001) RECONSTITUTION) 60064 250MG/5ML
(NEW INDICATION --
TREATMENT OF COMMUNITY-
ACQUIRED PNEUMONIA CAUSED
BY MYCOPLASMA PNEUMONIAE,
CHLAMYDIA PNEUMONIAE, AND
STREPTOCOCCUS PNEUMONIAE
IN CHILDREN)
50-711 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE
18-JUL-96 (TABLET) NEW YORK, NY EQ 250MG BASE
(3 S) 10017 (ANTIBIOTIC, MACROLIDE)
[TREATMENT OF MILD TO
MODERATE INFECTIONS
CAUSED BY SUSCEPTIBLE
STRAINS OF DESIGNATED
MICROORGANISMS IN
SPECIFIC
CONDITIONS]
20-554 DOVONEX BRISTOL MYERS SQUIBB CALCIPOTRIENE
22-JUL-96 (CREAM) BUFFALO, NY 0.005%
(3 S) 14213 (ANTIPSORIATIC)
[TREATMENT OF PLAQUE
PSORIASIS]
20-037 VOLTAREN CIBAVISION DICLOFENAC SODIUM
23-JUL-96 (SOLUTION/DROPS) DULUTH, GA 0.1%
(SUPPL-007) 30155 (NEW INDICATION --
TREATMENT OF PHOTOPHOBIA)
20-625 ALLEGRA HOECHST MARION RSSL FEXOFENADINE
HYDROCHLORIDE
25-JUL-96 (CAPSULE) KANSAS CITY, MO 60MG
(1 S) 64134 (HISTAMINE H-1 RECEPTOR
ANTAGONIST)
[TREATMENT OF SYMPTOMS
ASSOCIATED WITH SEASONAL
ALLERGIC RHINITIS]
20-525 GYNE-LOTRIMIN 3 SCHERING PLOUGH HLTH CLOTRIMAZOLE
29-JUL-96 (SUPPOSITORY) LIBERTY CORNER, NJ 200MG
(6 S) 07938 (ANTIFUNGAL)
[TREATMENT OF RECURRENT
VAGINAL YEAST INFECTIONS]
(OTC)
20-526 GYNE-LOTRIMIN 3 SCHERING PLOUGH CLOTRIMAZOLE
29-JUL-96 COMBINATION PACK LIBERTY CORNER, NJ 1%-(CREAM)
(6 S) (CREAM/SUPPOSITORY) 07938 100MG-(SUPPOSITORY)
(ANTIFUNGAL)
[TREATMENT OF RECURRENT
VAGINAL YEAST INFECTIONS
AND RELIEF OF ASSOCIATED
EXTERNAL ITCHING AND
IRRITATION OF THE VULVA]
(OTC)
50-517 MEFOXIN MSD CEFOXITIN SODIUM
30-JUL-96 (INJECTABLE) WEST POINT, PA EQ 1GM BASE/VIAL
(SUPPL-028) 19486 EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
(NEW INDICATION --
ADDITION OF EIKENELLA
CORRODENS TO THE PACKAGE
INSERT)
50-581 MEFOXIN MSD CEFOXITIN SODIUM
30-JUL-96 IN DEXTROSE 5% WEST POINT, PA EQ 20MG BASE/ML
(SUPPL-016) IN PLASTIC CONTAINER 19486 EQ 40MG BASE/ML
(INJECTABLE) (NEW INDICATION --
ADDITION OF EIKENELLA
CORRODENS TO THE PACKAGE
INSERT)
20-536 NICOTROL MCNEIL CONS PRODS NICOTINE
31-JUL-96 (FILM, FORT WASHINGTON, PA 15MG/16HR
(6 S) EXTENDED RELEASE) 19034 (SMOKING DETERRENT)
[AID TO SMOKING
CESSATION]
(OTC)
20-538 ESTRADIOL MENOREST ESTRADIOL
31-JUL-96 (FILM, MIAMI, FL 0.0375MG/24HR
(5 S) EXTENDED RELEASE) 33186 0.075MG/24HR
0.05MG/24HR
0.1MG/24HR
(ESTROGEN)
[TREATMENT OF ESTROGEN
DEFICIENCY SYNDROME]
***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.
19-815 PROAMATINE ROBERTS PHARM MIDODRINE HYDROCHLORIDE
06-JUN-96 (TABLET) EATONTOWN, NJ 2.5MG
07724 5MG
(ANTIHYPOTENSIVE)
20-519 LOPROX HOECHST MARION RSSL CICLOPIROX
02-JUL-96 (GEL) BRIDGEWATER, NJ 0.77%
08807 (ANTIFUNGAL)
20-584 LODINE XL WYETH AYERST ETODOLAC
03-JUL-96 (TABLET, PHILADELPHIA, PA 400MG
EXTENDED RELEASE) 19101 600MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
20-453 PANDEL SAVAGE LABS HYDROCORTISONE BUTEPRATE
11-JUL-96 (CREAM) MELVILLE, NY 0.1%
11747 (CORTICOSTEROID)
20-601 CHILDREN'S MOTRIN MCNEIL CONS PRODS IBUPROFEN
11-JUL-96 (TABLET, CHEWABLE) FORT WASHINGTON, PA 50MG
19034 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
20-601 JUNIOR STRENGTH MCNEIL CONS PRODS IBUPROFEN
***APPROVABLE ORIGINAL NDAs***
11-JUL-96 MOTRIN FORT WASHINGTON, PA 100MG
(TABLET, CHEWABLE) 19034 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
20-580 COTAZYM ORGANON PANCRELIPASE
19-JUL-96 (CAPSULE) WEST ORANGE, NJ 68000USPU
07052 (ENZYME)
20-606 IMODIUM ADVANCED MCNEIL CONS PRODS LOPERAMIDE HYDROCHLORIDE
23-JUL-96 (TABLET, CHEWABLE) FORT WASHINGTON, PA 2MG
19034 SIMETHICONE
125MG
(ANTIDIARRHEAL/
ANTIFLATULENT)
(OTC)
20-430 ORGARAN ORGANON DANAPAROID SODIUM
24-JUL-96 (INJECTABLE) WEST ORANGE, NJ 750UNITS/0.6ML
07052 (ANTITHROMBOTIC)
20-521 INFASURF ONY LUNG SURFACTANT EXTRACT, 25-JUL-96 (SUSPENSION) AMHERST, NY CALF
14228 37MG/ML (LIPIDS)
0.7MG/ML (PROTEINS)
(LUNG SURFACTANT
REPLACEMENT)
***ORIGINAL ABBREVIATED NDAs***
64-126 ERYTHROMYCIN STIEFEL ERYTHROMYCIN
03-JUL-96 (SWAB) CORAL GABLES, FL 2%
33134 (ANTIBIOTIC, MACROLIDE)
64-128 ERYTHROMYCIN STIEFEL ERYTHROMYCIN
03-JUL-96 (SWAB) CORAL GABLES, FL 2%
33134 (ANTIBIOTIC, MACROLIDE)
74-249 CLOBETASOL TARO CLOBETASOL PROPIONATE
08-JUL-96 PROPIONATE BRAMALEA, ONTARIO 0.05%
(CREAM) CANADA (CORTICOSTEROID)
40-120* PROCHLORPERAZINE COPLEY PHARM PROCHLORPERAZINE MALEATE
11-JUL-96 MALEATE CANTON, MA EQ 5MG BASE
(TABLET) 02021 EQ 10MG BASE
(ANTIEMETIC,
ANTIPSYCHOTIC)
74-248 CLOBETASOL TARO CLOBETASOL PROPIONATE
12-JUL-96 PROPIONATE BRAMALEA, ONTARIO 0.05%
(OINTMENT) CANADA (CORTICOSTEROID)
40-156 HYDROXYZINE PAMOATE CHELSEA LABS HYDROXYZINE PAMOATE
15-JUL-96 (CAPSULE) CINCINNATI, OH EQ 25MG HCL
45215 EQ 50MG HCL
(ANXIOLYTIC/ANTIPRURITIC)
64-030 ERYTHROMYCIN ADV REMEDIES ERYTHROMYCIN
18-JUL-96 (OINTMENT) SOMERSET, NJ 0.5%
08873 (ANTIBIOTIC, MACROLIDE)
74-642* NICARDIPINE HCL MYLAN NICARDIPINE HYDROCHLORIDE
18-JUL-96 (CAPSULE) MORGANTOWN, WV 20MG
26505 30MG
(CALCIUM ION INFLUX
INHIBITOR)
40-101 PROCHLORPERAZINE INVAMED PROCHLORPERAZINE MALEATE
19-JUL-96 MALEATE DAYTON, NJ EQ 5MG BASE
(TABLET) 08810 EQ 10MG BASE
EQ 25MG BASE*
(ANTIEMETIC,
ANTIPSYCHOTIC)
74-529 ETOPOSIDE GENSIA LABS ETOPOSIDE
24-JUL-96 (INJECTABLE) IRVINE, CA 20MG/ML
92718 (ANTINEOPLASTIC)
* - First Time Product Available Generically
40-069 DEXAMETHASONE SODIUM BAUSCH AND LOMB DEXAMETHASONE SODIUM 26-JUL-96 PHOSPHATE TAMPA, FL PHOSPHATE
(SOLUTION/DROPS) 33637 EQ 0.1% PHOSPHATE
(CORTICOSTEROID)
40-095 HEPARIN SODIUM SANOFI WINTHROP HEPARIN SODIUM
26-JUL-96 (INJECTABLE) NEW YORK, NY 10,000 UNITS/ML
10016 (ANTICOAGULANT)
40-166 ACETIC ACID MORTON GROVE ACETIC ACID, GLACIAL
26-JUL-96 (SOLUTION/DROPS) MORTON GROVE, IL 2%
60053 (ANTIMICROBIAL)
40-084+ ANEXIA 10/660 MALLINCKRODT ACETAMINOPHEN
29-JUL-96 (TABLET) CHESTERFIELD, MO 660MG
63017 HYDROCODONE BITARTRATE
10MG
(ANALGESIC)
74-580 CLOTRIMAZOLE TARO CLOTRIMAZOLE
29-JUL-96 (SOLUTION) BRAMALEA, ONTARIO 1%
CANADA (ANTIFUNGAL)
40-105 OXYCODONE AND VINTAGE PHARMS ACETAMINOPHEN
30-JUL-96 ACETAMINOPHEN CHARLOTTE, NC 325MG
(TABLET) 28206 OXYCODONE
5MG
(ANALGESIC)
40-106 OXYCODONE AND VINTAGE PHARMS ACETAMINOPHEN
30-JUL-96 ACETAMINOPHEN CHARLOTTE, NC 500MG
(CAPSULE) 28206 OXYCODONE
5MG
(ANALGESIC)
74-511 SULSTER AKORN PREDNISOLONE SODIUM 30-JUL-96 (SOLUTION/DROPS) ABITA SPRINGS, IL PHOSPHATE
70423 EQ 0.23% PHOSPHATE
SULFACETAMIDE SODIUM
10%
(CORTICOSTEROID/
ANTIBACTERIAL)
74-623 LACTULOSE PHARM ASSOC LACTULOSE
30-JUL-96 (SOLUTION) CONESTEE, SC 10GM/15ML
29636 (LAXATIVE/AMMONIA
DETOXICANT)
+ - Supplemental Abbreviated NDA
40-027 PROMETHAZINE HCL AND HI TECH PHARMA DEXTROMETHORPHAN
31-JUL-96 DEXTROMETHORPHAN AMITYVILLE, NY HYDROBROMIDE
HYDROBROMIDE 11701 15MG/5ML
(SYRUP) PROMETHAZINE HYDROCHLORIDE
6.25MG/5ML
(ANTITUSSIVE/
ANTIHISTAMINIC)
74-625 OXYBUTYNIN CHLORIDE ROSEMONT OXYBUTYNIN CHLORIDE
31-JUL-96 (TABLET) DENVER, CO 5MG
80223 (ANTISPASMODIC)
***ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVAL***
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.
74-776 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE
26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.5%
33637 (BETA ADRENERGIC BLOCKER)
74-778 TIMOLOL MALEATE BAUSCH AND LOMB TIMOLOL MALEATE
26-JUL-96 (SOLUTION/DROPS) TAMPA, FL 0.25%
33637 (BETA ADRENERGIC BLOCKER)
74-465 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE
30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.25%
08873 (BETA ADRENERGIC BLOCKER)
74-466 TIMOLOL MALEATE ADV REMEDIES TIMOLOL MALEATE
30-JUL-96 (SOLUTION/DROPS) SOMERSET, NJ 0.5%
08873 (BETA ADRENERGIC BLOCKER)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
19-898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM
02-JUL-96 (TABLET) PRINCETON, NJ 10MG
08543 20MG
40MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE)
17-962 PARLODEL SANDOZ BROMOCRIPTINE MESYLATE
03-JUL-96 (CAPSULE) EAST HANOVER, NJ EQ 5MG BASE
07936 (LABELING REVISION --
DESCRIPTION;
CONTRAINDICATIONS;
PRECAUTIONS; OVERDOSAGE)
17-962 PARLODEL SANDOZ BROMOCRIPTINE MESYLATE
03-JUL-96 (TABLET) EAST HANOVER, NJ EQ 2.5MG BASE
07936 (LABELING REVISION --
DESCRIPTION;
CONTRAINDICATIONS;
PRECAUTIONS; OVERDOSAGE)
19-885 ACCUPRIL PARKE DAVIS QUINAPRIL HYDROCHLORIDE
03-JUL-96 (TABLET) MORRIS PLAINS, NJ EQ 5MG BASE
07950 EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
(LABELING REVISION --
WARNINGS; PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
14-684 AVENTYL HCL LILLY NORTRIPTYLINE
HYDROCHLORIDE
08-JUL-96 (CAPSULE) INDIANAPOLIS, IN EQ 10MG BASE
46285 EQ 25MG BASE
(LABELING REVISION --
PRECAUTIONS; OVERDOSAGE)
14-685 AVENTYL HCL LILLY NORTRIPTYLINE
HYDROCHLORIDE
08-JUL-96 (SOLUTION) INDIANAPOLIS, IN EQ 10MG BASE/5ML
46285 (LABELING REVISION --
PRECAUTIONS; OVERDOSAGE)
18-012 PAMELOR SANDOZ NORTRIPTYLINE
HYDROCHLORIDE
08-JUL-96 (SOLUTION) EAST HANOVER, NJ EQ 10MG BASE/5ML
07936 (LABELING REVISION --
PRECAUTIONS; OVERDOSAGE)
18-013 PAMELOR SANDOZ NORTRIPTYLINE
HYDROCHLORIDE
08-JUL-96 (CAPSULE) EAST HANOVER, NJ EQ 10MG BASE
07936 EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
(LABELING REVISION --
PRECAUTIONS; OVERDOSAGE)
18-533 NIZORAL JANSSEN PHARM KETOCONAZOLE
08-JUL-96 (TABLET) PISCATAWAY, NJ 200MG
08854 (LABELING REVISION --
BOXED WARNING;
CONTRAINDICATIONS;
PRECAUTIONS;
ADVERSE REACTIONS)
20-236 SEREVENT GLAXO SALMETEROL XINAFOATE
09-JUL-96 (AEROSOL, METERED) RES TRIANGLE PK, NC 0.025MG/INH
27709 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
18-780 HUMULIN R LILLY INSULIN BIOSYNTHETIC HUMAN
10-JUL-96 (INJECTABLE) INDIANAPOLIS, IN 100 UNITS/ML
46285 (LABELING REVISION --
PATIENT LABELING)
(OTC)
18-781 HUMULIN N LILLY INSULIN SUSP ISOPHANE 10-JUL-96 (INJECTABLE) INDIANAPOLIS, IN BIOSYNTHETIC HUMAN
46285 100 UNITS/ML
(LABELING REVISION --
PATIENT LABELING)
(OTC)
19-717 HUMULIN 70/30 LILLY INSULIN BIOSYNTHETIC
HUMAN
10-JUL-96 (INJECTABLE) INDIANAPOLIS, IN 30 UNITS/ML
46285 INSULIN SUSP ISOPHANE BIOSYNTHETIC HUMAN
70 UNITS/ML
(LABELING REVISION --
PATIENT LABELING)
(OTC)
20-489 ANDRODERM THERATECH TESTOSTERONE
10-JUL-96 (FILM, SALT LAKE CITY, UT 2.5MG/24HR
EXTENDED RELEASE) 84108 (LABELING REVISION --
ADVERSE REACTIONS;
PATIENT PACKAGE INSERT)
18-981 ENKAID BRISTOL MYERS SQUIBB ENCAINIDE HYDROCHLORIDE
15-JUL-96 (CAPSULE) PRINCETON, NJ 25MG
08543 35MG
(LABELING REVISION --
DESCRIPTION; WARNINGS;
PRECAUTIONS; HOW
SUPPLIED)
20-036 AREDIA CIBA GEIGY PAMIDRONATE DISODIUM
16-JUL-96 (INJECTABLE) SUMMIT, NJ 30MG/VIAL
07901 60MG/VIAL
90MG/VIAL
(LABELING REVISION --
INDICATIONS AND USAGE;
ADVERSE REACTIONS)
20-154 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
17-JUL-96 (TABLET, CHEWABLE) WALLINGFORD, CT 25MG
06492 50MG
100MG
150MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-155 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
17-JUL-96 (POWDER FOR WALLINGFORD, CT 100MG/PACKET
RECONSTITUTION) 06492 167MG/PACKET
250MG/PACKET
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-156 VIDEX BRISTOL MYERS SQUIBB DIDANOSINE
17-JUL-96 (POWDER FOR WALLINGFORD, CT 10MG/ML
RECONSTITUTION) 06492 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
50-698 BIAXIN ABBOTT CLARITHROMYCIN
17-JUL-96 (GRANULE, FOR ABBOTT PARK, IL 125MG/5ML
RECONSTITUTION) 60064 250MG/5ML
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-386 COZAAR MERCK LOSARTAN POTASSIUM
18-JUL-96 (TABLET) WEST POINT, PA 25MG
19486 50MG
(LABELING REVISION --
PRECAUTIONS; HOW
SUPPLIED)
20-387 HYZAAR MERCK HYDROCHLOROTHIAZIDE
18-JUL-96 (TABLET) WEST POINT, PA 12.5MG
19486 LOSARTAN POTASSIUM --
50MG
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
19-949 DIFLUCAN PFIZER FLUCONAZOLE
23-JUL-96 (TABLET) GROTON, CT 50MG
06340 100MG
150MG
200MG
(LABELING REVISION --
PRECAUTIONS)
19-950 DIFLUCAN PFIZER FLUCONAZOLE
23-JUL-96 (INJECTABLE) NEW YORK, NY 2MG/ML
10017 (LABELING REVISION --
PRECAUTIONS)
20-037 VOLTAREN CIBAVISION DICLOFENAC SODIUM
23-JUL-96 (SOLUTION/DROPS) DULUTH, GA 0.1%
30155 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-065 OPCON-A BAUSCH AND LOMB NAPHAZOLINE HYDROCHLORIDE
23-JUL-96 (SOLUTION/DROPS) ROCHESTER, NY 0.027%
14692 PHENIRAMINE MALEATE
0.315%
(LABELING REVISION --
PATIENT LABELING)
(OTC)
20-090 DIFLUCAN PFIZER FLUCONAZOLE
23-JUL-96 (POWDER FOR NEW YORK, NY 50MG/5ML
RECONSTITUTION) 10017 200MG/5ML
(LABELING REVISION --
PRECAUTIONS)
19-826 THEOPHYLLINE 0.04% MCGAW THEOPHYLLINE
24-JUL-96 AND DEXTROSE 5% IRVING, CA 40MG/100ML
IN PLASTIC CONTAINER 92713 (LABELING REVISION --
(INJECTABLE) SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
19-826 THEOPHYLLINE 0.08% MCGAW THEOPHYLLINE
24-JUL-96 AND DEXTROSE 5% IRVING, CA 80MG/100ML
IN PLASTIC CONTAINER 92713 (LABELING REVISION --
(INJECTABLE) SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
19-826 THEOPHYLLINE 0.16% MCGAW THEOPHYLLINE
24-JUL-96 AND DEXTROSE 5% IRVING, CA 160MG/100ML
IN PLASTIC CONTAINER 92713 (LABELING REVISION --
(INJECTABLE) SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
19-826 THEOPHYLLINE 0.32% MCGAW THEOPHYLLINE
24-JUL-96 AND DEXTROSE 5% IRVING, CA 320MG/100ML
IN PLASTIC CONTAINER 92713 (LABELING REVISION --
(INJECTABLE) SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM
24-JUL-96 (TABLET) PRINCETON, NJ 10MG
08543 20MG
40MG
(LABELING REVISION --
INDICATIONS AND
USAGE;WARNINGS)
20-286 MONOPRIL-HCT BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM
24-JUL-96 (TABLET) PRINCETON, NJ 10MG
08543 HYDROCHLOROTHIAZIDE
12.5MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS; WARNINGS;
ADVERSE REACTIONS)
20-286 MONOPRIL-HCT BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM
24-JUL-96 (TABLET) PRINCETON, NJ 20MG
08543 HYDROCHLOROTHIAZIDE
12.5MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS; WARNINGS;
ADVERSE REACTIONS)
20-071 DESOGEN ORGANON DESOGESTREL
26-JUL-96 (TABLET) WEST ORANGE, NJ 0.15MG
07052 ETHINYL ESTRADIOL
0.03MG
(LABELING REVISION --
WARNINGS; DETAILED
PATIENT PACKAGE INSERT)
19-937 ADENOCARD MEDCO ADENOSINE
29-JUL-96 (INJECTABLE) RES TRIANGLE PK, NC 3MG/ML
27709 (LABELING REVISION --
WARNINGS; PRECAUTIONS)
20-047 DEXTROSE 50% BAXTER DEXTROSE
29-JUL-96 IN PLASTIC CONTAINER ROUND LAKE, IL 50GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-047 DEXTROSE 60% BAXTER DEXTROSE
29-JUL-96 IN PLASTIC CONTAINER ROUND LAKE, IL 60GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-047 DEXTROSE 70% BAXTER DEXTROSE
29-JUL-96 IN PLASTIC CONTAINER ROUND LAKE, IL 70GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-363 FAMVIR SMITHKLINE BEECHAM FAMCICLOVIR
29-JUL-96 (TABLET) PHILADELPHIA, PA 125MG
19101 250MG
500MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
16-211 MIOCHOL CIBAVISION ACETYLCHOLINE CHLORIDE
30-JUL-96 (POWDER FOR DULUTH, GA 20MG/VIAL
RECONSTITUTION) 30155 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-226 NAPHCON-A ALCON NAPHAZOLINE HYDROCHLORIDE
30-JUL-96 (SOLUTION/DROPS) FORTH WORTH, TX 0.025%
76134 PHENIRAMINE MALEATE
0.3%
(LABELING REVISION --
PATIENT LABELING)
(OTC)
50-517 MEFOXIN MSD CEFOXITIN SODIUM
30-JUL-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
30-JUL-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)
18-343 CAPOTEN BRISTOL MYERS SQUIBB CAPTOPRIL
31-JUL-96 (TABLET) PRINCETON, NJ 12.5MG
08543 25MG
50MG
100MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
HOW SUPPLIED)
18-709 CAPOZIDE 25/15 BRISTOL MYERS SQUIBB CAPTOPRIL
31-JUL-96 (TABLET) PRINCETON, NJ 25MG
08543 HYDROCHLOROTHIAZIDE
15MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS)
18-709 CAPOZIDE 25/25 BRISTOL MYERS SQUIBB CAPTOPRIL
31-JUL-96 (TABLET) PRINCETON, NJ 25MG
08543 HYDROCHLOROTHIAZIDE
25MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS)
18-709 CAPOZIDE 50/15 BRISTOL MYERS SQUIBB CAPTOPRIL
31-JUL-96 (TABLET) PRINCETON, NJ 50MG
08543 HYDROCHLOROTHIAZIDE
15MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS)
18-709 CAPOZIDE 50/25 BRISTOL MYERS SQUIBB CAPTOPRIL
31-JUL-96 (TABLET) PRINCETON, NJ 50MG
08543 HYDROCHLOROTHIAZIDE
25MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS)
18-998 VASOTEC MERCK ENALAPRIL MALEATE
31-JUL-96 (TABLET) WEST POINT, PA 2.5MG
19486 5MG
10MG
20MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
OVERDOSAGE)
19-221 VASERETIC MERCK ENALAPRIL MALEATE
31-JUL-96 (TABLET) WEST POINT, PA 5MG
19486 HYDROCHLOROTHIAZIDE
12.5MG
(LABELING REVISION --
DESCRIPTION;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
OVERDOSAGE)
19-221 VASERETIC MERCK ENALAPRIL MALEATE
31-JUL-96 (TABLET) WEST POINT, PA 10MG
19486 HYDROCHLOROTHIAZIDE
25MG
(LABELING REVISION --
DESCRIPTION;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
OVERDOSAGE)
19-309 VASOTEC MERCK ENALAPRILAT
31-JUL-96 (INJECTABLE) WEST POINT, PA 1.25MG/ML
19486 (LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
OVERDOSAGE; HOW SUPPLIED)
20-564 EPIVIR GLAXO WELLCOME LAMIVUDINE
31-JUL-96 (TABLET) RES TRIANGLE PK, NC 150MG
27709 (LABELING REVISION --
BOXED WARNING;
INDICATIONS AND USAGE;
DESCRIPTION OF CLINICAL
STUDIES)
20-596 EPIVIR GLAXO WELLCOME LAMIVUDINE
31-JUL-96 (SOLUTION) RES TRIANGLE PK, NC 10MG/ML
27709 (LABELING REVISION --
BOXED WARNING;
INDICATIONS AND USAGE;
DESCRIPTION OF CLINICAL
STUDIES)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
1178 MYOSCINT CENTOCOR BV IMCIROMAB PENTETATE
07-03-96 (NONE) NETHERLANDS (CARDIA IMAGING AGENT FOR
DETECTING MYOCARDIAL
NECROSIS) (B)
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK940035 OLYMPUS PK CMV HEMAGEN DIAGN ANTI-CMV KIT
07-15-96 SYSTEM AND WALTHAM, MA (C)
SYSTEM CONTROLS 02154
BK880007 FRESENIUS AS104 FRESENIUS USA AUTOMATED BLOOD CELL
SEPARATOR
07-22-96 CELL SEPARATOR WALNUT CREEK, CA (C)
94598
BP950002 HOME ACCESS HIV-1 HOME ACCESS HLTH HIV SAMPLE COLLECTION KIT
07-22-96 TEST SYSTEM HOFFMAN ESTATES, IL (D)
60195
BK950063 RED BLOOD CELL & HAEMONETICS APHEREIS COLLECTION SET
07-22-96 PLASMA APHERESIS BRAINTREE, MA (C)
SET #823 02184
(C) Substantially Equivalent
(D) Approved
***MEDICAL DEVICE - PREMARKET APPROVAL APPLICATIONS***
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
P940035 MATRITECH MATRITECH, INC. APPROVAL FOR THE
07/02/96 NMP22 TEST KIT NEWTON, MA MATRITECH NMP22 TEST
02160 KIT IS INDICATED AS AN AID IN THE MANAGEMENT
OF PATIENTS WITH
TRANSITIONAL CELL CARCINOM
OF THE URINARY TRACT
(TCC/UT) AFTER SURGICAL
TREATMENT TO IDENTIFY
THOSE PATIENTS WITH
OCCULT OR RAPIDLY
RECURRING TCC/UT
***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/S047 OSTEOBOND ZIMMER, INC. ADDITION OF TERMINOLOGY
07/31/96 COPOLYMER BONE WARSAW, IN OF "HALF BATCH,
CEMENT 46581-0708 SINGLE BATCH,
DOUBLE BATCH,
HALF PACK, SINGLE PACK,
AND DOUBLE PACK" TO
THE PACKAGE LABELS
P810046/S161 ACS OTW LIFESTREAM ADVANCED APPROVAL FOR THE ACS
07/29/96 CORONARY DILATATION CARDIOVASCULAR SYSTEMS OTW LIFESTREAM
CATHETER WITH THE SANTA CLARA, CA CORONARY DILATATION
CATHETER WITH 95052-8167 CATHETER WITH A 30 MM
30 MM BALLOON BALLOON LENGTH
LENGTH
P820003/S073 MODEL 5348 MEDTRONIC, INC. MODIFICATIONS TO THE
07/16/96 TEMPORARY MINNEAPOLIS, MN KEYPAD OF THE
PACEMAKER 55432-3576 MODEL 5348
TEMPORARY PACEMAKER
P820018/S063 AUTIMA/AURORA TELECTRONICS CHANGE IN
07/23/96 CARDIAC PACING PACING SYSTEM STERILIZATION
SYSTEM ENGLEWOOD, CO CONTRACTOR: GRIFFITH
80112 MICRO SCIENCE, INC.,
SMYRNA, GA 30080-7322
P820018/S065 REFLEX MODEL TELECTRONICS CHANGE IN
07/23/96 8223E PACING SYSTEM STERILIZATION
ENGLEWOOD, CO CONTRACTOR: GRIFFITH
80112 MICRO SCIENCE, INC.,
SMYRNA, GA 30080-7322
P820018/S066 REFLEX DDD TELECTRONICS PACING APPROVAL FOR THE USE
07/11/96 MODEL 1254 META SYSTEMS, INC. OF WILSON GREATBATCH
DDDR AND META II ENGLEWOOD, CO BATTERIES WHICH HAVE
PULSE GENERATORS 80112 UNDERGONE A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P830055/S046 NEW JERSEY LCS DEPUY, INC. ADDITION OF THE
07/17/96 TOTAL KNEE SYSTEM DISTRIBUTION CENTER POROUS-COATED
WARSAW, IN METAL-BACKED,
46581-0988 TEXTURED
METAL-BACKED, AND
ALL-POLYETHYLENE
THREE-PEGGED PATELLA
COMPONENT OPTIONS
P840039/S048 EZE-FIT STORZ OPHTHALMICS, INC. APPROVAL FOR THE
07/18/96 CLEARWATER, FL TRADE NAME EZE-FIT
34619 FOR THE ONE-PIECE
POLYMETHYLMETHACRYLATE
INTRAOCULAR LENSES
P850070/S008 STERILE AUTOMATIC LIQUID ALTERNATE CLOSURE
07/10/96 PRESERVED PACKAGING, INC. DESIGN WHICH UTILIZES
SALINE SOLUTION WOODSTOCK, IL A PIERCING CAP AND
60098-7498 "FLIP-TOP" ON 12 OZ.
AND 16 OZ. PRESERVED
SALINE SOLUTION
CONTAINERS ONLY
P860004/S022 MEDTRONIC MODELS MEDTRONIC, INC. 10CC SYNCHROMED
07/29/96 8616-10 AND 8616-10 MINNEAPOLIS, MN IMPLANTABLE
(10CC) MODELS 55440-9087 PROGRAMMABLE
8616-18, 8617-18, INFUSION PUMP MODELS
8617L-18, 8618-18 8616-10 AND 8617-10;
AND 8618L AND TO CHANGE THE
(18CC) INDICATIONS FOR THE
PROGRAMMABLE LIORESAL INTRATHECAL
INFUSION PUMPS 18CC RESERVOIR
P860005/S005 PRO OSTEON INTERPORE INTL. REVISION TO THE
07/18/96 IMPLANT 500 IRVINE, CA POST-MARKET STUDY
CORALLINE 92718-2402 PROTOCOL
HYDROXYAPATITE
BONE VOID FILLER
P860019/S111 SCIMED SURPASS SCIMED LIFE APPROVAL FOR THE
PERCUTANEOUS SYSTEMS, INC. SCIMED SURPASS
TRANSLUMINAL 55311-1566 PERCUTANEOUS
CORONARY TRANSLUMINAL
ANGIOPLASTY CORONARY
(PTCA) PERFUSION ANGIOPLASTY
CATHETER (PTCA) PERFUSION
CATHETER
P860026/S005 DIAPHRAGMATIC/ AVERY LABORATORIES, CHANGE IN
07/09/96 PHRENIC NERVE INC. MANUFACTURING
STIMULATOR COMMACK, NY FACILITY TO AVERY
11725-5703 LABORATORIES INC.,
COMMACK, NEW YORK
P860027/S011 MAESTRO II CARDIAC CONTROL ALTERNATE
07/09/96 MODEL 533 SYSTEMS, INC STERILIZATION
PACEMAKER SYSTEM PALM COAST, FL PROCEDURE
32164
P870023/S007 DESTAT 4 CLEANING, ALLERGAN OPTICAL ALTERNATE
07/12/96 DISINFECTING AND IRVINE, CA MANUFACTURING
STORAGE SOLUTION 92713-9534 SITE:ALLERGAN
OPTICAL, 8301 MARS
DRIVE, WACO, TEXAS
76712
P870025/S005 COROMETRICS COROMETRICS MEDICAL APPROVAL FOR A
07/17/96 MODEL 146 FETAL SYSTEMS, INC. LABELING CHANGE TO
ACOUSTICS WALLINGFORD, CT PERMIT INTERFACE OF
STIMULATOR 06492-0333 THE COROMETRICS MODEL
146 FETAL ACOUSTIC
STIMULATOR WITH THE
COROMETRICS MODEL 155
FETAL MONITOR
P870072/S001 THORATEC THORATEC LABORATORIES APPROVAL FOR ADDING
07/10/96 VENTRICULAR CORPORATION REFERENCES TO THE
ASSIST DEVICE BERKELEY, CA DIRECTIONS FOR USE
(VAD) SYSTEM 94710-2090
P880003/S060 CORDIS PTCA CORDIS CORPORATION MODIFIED HUB BONDING
07/26/96 DILATATION MIAMI, FL PROCESS
CATHETER 33102-5700
TRAKSTAR 14,
TRAKSTAR 18 AND
OLYMPIX II PTCA
DILATATION
CATHETERS
P880027/S039 SCHNEIDER GOLDIE SCHNEIDER (USA), INC. APPROVAL FOR THE
07/01/96 AND GOLDIE LONGY MINNEAPOLIS, MN GOLDIE AND GOLDIE
PTCA CATHETERS 55442 LONGY PTCA CATHETER
LINES
P880038/S028 MEDA-MV TELECTRONICS CHANGE IN
07/23/96 PACING SYSTEM PACING SYSTEMS STERILIZATION
ENGLEWOOD, CO CONTRACTOR: GRIFFITH
80112 MICRO SCIENCE, INC.
SMYRNA, GA 30080-7322
P880038/S029 META II TELECTRONICS APPROVAL FOR USE OF
07/11/96 PULSE GENERATOR PACING SYSTEMS, INC. WILSON GREATBATCH
MODEL 1254 ENGLEWOOD, CO BATTERIES WHICH HAVE
80112 UNDERGONE A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P880091/S006 ULTRAVIOLET- STAAR SURGICAL ADDITION OF ALTERNATE
07/01/96 ABSORBING ELASTIC COMPANY VENDOR FOR PART OF
AND ELASTIMIDE MONROVIA, CA THE MANUFACTURING
POSTERIOR CHAMBER 91016 PROCESS
INTRAOCULAR LENSES
(IOLS)
P890003/S043 MEDTRONIC THERA, MEDTRONIC, INC. APPROVAL FOR
07/01/96 PRODIGY AND PREVA MINNEAPOLIS, MN MARKETING OF A SUBSET
PULSE GENERATORS 55432-3576 OF PULSE GENERATORS
VITATRON LEGACY II FROM THE APPROVED
AND VISA PULSE THERA-I/PRODIGY
PULSE GENERATORS HARDWARE AND SOFTWARE
PLATFORMS
P890023/S003 OCUFILCON D OCULAR SCIENCES/ APPROVAL FOR TINTING,
07/12/96 SPHERICAL AND AMERICAN HYDRON WET PROCESSING,
TORIC EXTENDED CUPERTINO, CA PACKAGING, AND
WEAR CONTACT 95014 STERILIZATION AT THE
LENSES FACILITY LOCATED
AT SANTA ISABEL
INDUSTRIAL PARK,
PUERTO RICO 00757
P890039/S015 MAESTRO II CARDIAC CONTROL ALTERNATE
07/09/96 SAVVI PACING SYSTEMS, INC STERILIZATION
SYSTEM MODEL 325 PALM COAST, FL PROCEDURE
AND MODEL 333 32164
P900060/S010 CARBOMEDICS CARBOMEDICS, INC. USE OF AN AUTOMATED
07/02/96 PROSTHETIC HEART AUSTIN, TX LASER SYSTEM FOR
VALVE, MODELS S500 78752-1793 CUTTING SEWING CUFF
AND 700 MATERIAL
P900061/S022 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR
07/01/96 MODEL 7221 MINNEAPOLIS, MN MEDTRONIC MODEL 7221
B/C/CX/D/E 55432-3576 B/C/CX/D/E MICRO
MICRO JEWEL JEWEL WITH THE
W/MODEL 5434 MODEL 5434 ACTIVE CAN
ACTIVE CAN EMULATOR AND
EMULATOR AND MODEL 9894 SOFTWARE
MODEL 9894
SOFTWARE
P900070/S009 META DDDR TELECTRONICS CHANGE IN
07/23/96 PACING SYSTEM PACING SYSTEMS STERILIZATION
ENGLEWOOD, CO CONTRACTOR: GRIFFITH
80112 MICRO SCIENCE, INC.
SMYRNA, GA 30080-7322
P900070/S010 META DDDR TELECTRONICS PACING APPROVAL FOR THE USE
07/11/96 PULSE GENERATOR SYSTEMS, INC. OF WILSON GREATBATCH
MODEL 1254 ENGLEWOOD, CO BATTERIES WHICH HAVE
80112 UNDERGONE A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P910020/S012 UNITY MODEL 292-07 INTERMEDICS, INC. APPROVAL FOR THE
07/31/96 SINGLE PASS (VDDR) ANGLETON, TX UNITY MODEL 292-07
PULSE GENERATOR 77515 SINGLE PASS (VDDR)
WITH UNIPASS LEADS PULSE GENERATOR WITH
MODELS 425-02, UNIPASS LEADS MODELS
425-04 AND 425-06 425-02, 425-04 AND
AND MODEL 531-60 425-06 AND MODEL 531-
GRAPHICS PROGRAM 60 GRAPHICS PROGRAM
MODULE MODULE
P920015/S011 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR THE
07/26/96 MODEL 6932 LEAD MINNEAPOLIS, MN MEDTRONIC PUERTO
55432-3576 RICO, INC., VILLALBA
WEST INDUSTRIAL AREA,
VILLALBA, PUERTO RICO
TO MANUFACTURE THE
MEDTRONIC MODEL 6932
LEAD
P920032/S003 MICRO-PACE PACE MEDICAL, INC. ALTERNATE VENDOR FOR
07/19/96 MODEL 4553 WALTHAM, MA THE CALIBRATED MODULE
02154 ASSEMBLY FOR THE
MICRO-PACE MODEL 4553
P930027/S001 IMMULITE PSA DIAGNOSTIC PRODUCTS APPROVAL TO CHANGE
07/11/96 CORP. THE IMMUNORADIOMETRIC
LOS ANGELES, CA TEST SYSTEM FOR THE
90045 MEASUREMENT OF PSA
TO A SOLID PHASE,
TWO SITE
CHEMILUMINESCENT
IMMUNOMETRIC ASSAY
**ORIGINAL VETERINARY ANDAs***
200-134 FERTAGYL DAIRY INTERVET GONADORELIN DIACETATE
17-JUN-96 (SOLUTION) CATTLE MILLSBORO, DE TETRAHYDRATE
19966 43MCG/ML
***ORIGINAL ABBREVIATED VETERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR JULY 1996.
***SUPPLEMENTAL VETERINARY NADAs***
046-699 CTC-10,50,65,70,100 CATTLE, ALPHARMA CHLORTETRACYCLINE
16-FEB-96 & MICRO CTC 100 CALVES, FORT LEE, NJ 10,50,65,
(TYPE A SHEEP, 07024 70 & 100GM/LB
MEDICATED ARTICLE) SWINE,
CHICKENS,
TURKEYS
048-480 CHLORATET 50 CATTLE, ADM AN HLTH NUTRITION CHLORTETRACYCLINE
16-FEB-96 (TYPE A CALVES, FORT WAYNE, IN 50GM/LB
MEDICATED ARTICLE) SWINE, 46801
CHICKENS,
TURKEYS
048-761 AUREOMYCIN CATTLE, HOFFMAN LA ROCHE CHLORTETRACYCLINE
16-FEB-96 (TYPE A CALVES, NUTLEY, NJ 50,70,80,90,100,
MEDICATED ARTICLE) SHEEP, 07110 293GM/LB
SWINE,
CHICKENS,
TURKEYS
092-286 CLTC 10,20,30,50,70 CATTLE, PFIZER CHLORTETRACYCLINE
16-FEB-96 (TYPE A CALVES, WEST CHESTER, PA 10,20,30,50 & 70GM/LB
MEDICATED ARTICLE) SHEEP, 19380
SWINE,
CHICKENS,
TURKEYS
092-287 CLTC CALVES PFIZER CHLORTETRACYCLINE
16-FEB-96 TYPE A WEST CHESTER, PA 50,100GM/LB
MEDICATED ARTICLE 19380
(MEDICATED FEED
MILK REPLACER)
138-935 CHLORTETRACYCLINE CATTLE, PENNFIELD OIL CHLORTETRACYCLINE
16-FEB-96 50,60,70,80,100 & CALVES, OMAHA, NE 50,60,70,80,100GM/LB
100MR SHEEP, 68144
(TYPE A SWINE,
MEDICATED ARTICLE) CHICKENS,
TURKEYS
***SUPPLEMENTAL VETERINARY NADAs***
140-338 NAXCEL DAY-OLD UPJOHN CEFTIOFUR SODIUM
21-MAY-96 (POWDER) TURKEY KALAMAZOO, MI 50MG/ML
POULTS 49001
200-008 OXY-TET BEEF BOEHRINGER INGELHEIM OXYTETRACYCLINE
22-MAY-96 (SOLUTION) CATTLE, AN HLTH 200MG/ML
NON- ST JOSEPH, MO
LACTATING 64506
DAIRY
CATTLE,
SWINE
138-412 HEARTGARD-30 DOG MERCK RES LABS IVERMECTIN
14-JUN-96 (TABLET) RAHWAY, NJ 68,136, AND
07065 272MCG/TABLET
140-886 HEARTGARD-30 DOG MERCK RES LABS IVERMECTIN
14-JUN-96 (CHEWABLE CUBES) RAHWAY, NJ 68,136, AND
07065 272MCG/CUBE
048-761 AUREOMYCIN PASTURE HOFFMAN LAROCHE CHLORTETRACYCLINE
09-JUL-96 (TYPE A CATTLE NUTLEY, NJ 4GM/LB
MEDICATED ARTICLE) 07110
Date created: October 3, 1996; last updated: June 20, 2004 |
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