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FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 18 Number (9) September 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
16-968 MIOSTAT ALCON LABS CARBACHOL
18-AUG-95 (SOLUTION) FORT WORTH, TX 0.01%
(SUPPL-013) 76134 (NEW INDICATION --
TO REDUCE THE
INTENSITY
OF INTRAOCULAR
PRESSURE
ELEVATION IN THE
FIRST
24 HOURS AFTER
CATARACT
SURGERY)
20-036 AREDIA CIBA GEIGY PAMIDRONATE DISODIUM
01-SEP-95 (INJECTABLE) SUMMIT, NJ 30MG/VIAL
(SUPPL-009) 07901 60MG/VIAL
90MG/VIAL
(NEW INDICATION --
BONE METASTASES
ASSOCIATED
WITH MULTIPLE
MYELOMA)
19-955 DDAVP RHONE POULENC RORER DESMOPRESSIN ACETATE
06-SEP-95 (TABLET) COLLEGEVILLE, PA 0.1MG
(3 S) 19426 0.2MG
(HORMONE ANALOGUE)
[ANTIDIURETIC
REPLACEMENT
THERAPY IN THE
MANAGEMENT
OF CENTRAL DIABETES
INSIPIDUS AND FOR
THE MANAGEMENT OF
TEMPORARY
POLYURIA AND
POLYDIPSIA
FOLLOWING HEAD
TRAUMA OR SURGERY IN
THE PITUITARY
REGION]
20-482 PRECOSE BAYER ACARBOSE
06-SEP-95 (TABLET) WEST HAVEN, CT 50MG
(1 S) 06516 100MG
(ALPHA-GLUCOSIDASE
INHIBITOR)
[ADJUNCT TO DIET
TO LOWER BLOOD
GLUCOSE
IN PATIENTS WITH
NON-INSULIN
-DEPENDENT
DIABETES MELLITUS
WHOSE
HYPERGLYCEMIA CANNOT
BE MANAGED ON DIET
ALONE - ALSO FOR USE
IN COMBINATION
WITH A SULFONYLUREA
WHEN DIET PLUS
PRECOSE OR A
SULFONYLUREA DO NOT
RESULT IN ADEQUATE
GLYCEMIC CONTROL]
20-428 AZELEX ALLERGAN AZELAIC ACID
13-SEP-95 (CREAM) IRVINE, CA 20%
(1 S) 92713 (DICARBOXYLIC ACID)
[TREATMENT OF MILD-
TO-MODERATE
INFLAMMATORY
ACNE VULGARIS]
20-297 COREG SMITHKLINE BEECHAM CARVEDILOL
14-SEP-95 (TABLET) PHILADELPHIA, PA 6.25MG
(1 S) 19101 12.5MG
25MG
(BETA ADRENERGIC
BLOCKER)
[HYPERTENSION]
20-398 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE
15-SEP-95 (SUSPENSION) TITUSVILLE, NJ EQ 1MG BASE/ML
(1 S) 08560 (UPPER GI TRACT MOTILITY
STIMULATOR)
50-703 BACTROBAN SMITHKLINE BEECHAM MUPIROCIN CALCIUM
18-SEP-95 (OINTMENT) PHILADELPHIA, PA EQ 2% ACID
(2 S) 19101 (ANTIBACTERIAL)
[INFECTION CONTROL IN
SELECT PATIENT POPULATIONS]
20-444 FLOLAN BURROUGHS WELLCOME EPOPROSTENOL SODIUM
20-SEP-95 (INJECTABLE) RES TRIANGLE PK, NC EQ 0.5MG BASE/VIAL
(1 P) 27709 EQ 1.5MG BASE/VIAL
(PROSTAGLANDIN)
[LONG-TERM INTRAVENOUS
TREATMENT OF PRIMARY
PULMONARY HYPERTENSION IN
NYHA CLASS III AND CLASS IV
ADULT PATIENTS]
20-531 METROCREAM GALDERMA METRONIDAZOLE
20-SEP-95 (CREAM) FORT WORTH, TX 0.75%
(3 S) 76163 (ANTIPROTOZOAL/
ANTIBACTERIAL)
[TREATMENT OF INFLAMMATORY
PAPULES AND PUSTULES OF
ROSACEA]
19-971 DEXTROSE 5% DHL DEXTROSE
28-SEP-95 IN PLASTIC UNION, SC 5GM/100ML
(5 S) CONTAINER 29379 (FLUID AND NUTRIENT
(INJECTABLE) REPLENISHER)
20-510 SPORANOX JANSSEN ITRACONAZOLE
28-SEP-85 (CAPSULE) TITUSVILLE, NJ 100MG
(6 S) 08560 (ANTIFUNGAL)
[TREATMENT OF ONYCHOMYCOSIS
DUE TO DERMATOPHYTES (TINEA
UNGUIUM) OF THE TOENAIL WITH
OR WITHOUT FINGERNAIL
INVOLVEMENT]
20-489 ANDRODERM THERATECH TESTOSTERONE
29-SEP-95 (FILM, SALT LAKE CITY, UT 2.5MG/24HR
(3 S) EXTENDED) 84108 (ANDROGEN)
RELEASE) (TESTOSTERONE REPLACEMENT
THERAPY IN MEN FOR
CONDITIONS ASSOCIATED WITH
A DEFICIENCY OR ABSENCE OF
ENDOGENOUS TESTOSTERONE)
20-560 FOSAMAX MERCK ALENDRONATE SODIUM
29-SEP-95 (TABLET) WEST POINT, PA EQ 10MG BASE
(1 P) 19486 EQ 40MG BASE
(BONE-RESORPTION INHIBITOR)
[TREATMENT OF OSTEOPOROSIS
IN POSTMENOPAUSAL WOMEN AND
PAGET'S DISEASE OF BONE]
***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.
50-685 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE
07-SEP-95 (CAPSULE) KENILWORTH, NJ EQ 400MG BASE
07033 (CEPHALOSPORIN)
50-686 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE
07-SEP-95 (POWDER, KENILWORTH, NJ EQ 90MG BASE/5ML
FOR ORAL 07033 EQ 180MG BASE/5ML
SUSPENSION) (CEPHALOSPORIN)
20-498 CASODEX ZENECA BICALUTAMIDE
14-SEP-95 (TABLET) WILMINGTON, DE 50MG
19850 (ANTIANDROGEN)
[USE IN COMBINATION THERAPY
WITH A LUTEINIZING-HORMONE
RELEASING HORMONE (LHRH)
ANALOGUE FOR THE TREATMENT
OF ADVANCED PROSTATE CANCER]
20-346 ZYRTEC PFIZER CETIRIZINE HYDROCHLORIDE
20-SEP-95 (SYRUP) NEW YORK, NY 5MG/5ML
10017 (H1-RECEPTOR ANTAGONIST)
[SEASONAL ALLERGIC RHINITIS;
PERENNIAL ALLERGIC RHINITIS;
CHRONIC URTICARIA]
20-528 MAVIK KNOLL PHARM TRANDOLAPRIL
25-SEP-95 (TABLET) WHIPPANY, NJ 1MG
07981 2MG
4MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
[HYPERTENSION]
20-479 GASTROCROM FISONS CROMOLYN SODIUM
26-SEP-95 (CONCENTRATE) ROCHESTER, NY 100MG/5ML
14603 (MAST CELL STABILIZER)
[MANAGEMENT OF PATIENTS
WITH MASTOCYTOSIS]
20-457 ETOPOPHOS BRISTOL MYERS SQUIBB ETOPOSIDE PHOSPHATE
28-SEP-95 (INJECTABLE) WALLINGFORD, CT EQ 100MG BASE/VIAL
06492 (ANTINEOPLASTIC)
20-519 LOPROX HOECHST ROUSSEL CICLOPIROX
28-SEP-95 (GEL) SOMERVILLE, NJ 0.77%
08876 (ANTIFUNGAL)
20-468 NASACORT AQ RHONE POULENC RORER TRIAMCINOLONE ACETONIDE
29-SEP-95 (SPRAY, COLLEGEVILLE, PA 0.055MG/INH
METERED) 19426 (CORTICOSTEROID)
[TREATMENT OF SEASONAL
AND PERENNIAL ALLERGIC
RHINITIS]
20-472 ESTRING PHARMACIA ESTRADIOL
29-SEP-95 (INSERT, COLUMBUS, OH 2MG
EXTENDED 43216 (ESTROGEN)
RELEASE) [TREATMENT OF POSTMENOPAUSAL
UROGENITAL COMPLAINTS DUE TO
ESTROGEN DEFICIENCY]
***ORIGINAL ABBREVIATED NDAs***
64-135 DEXASPORIN BAUSCH AND LOMB DEXAMETHASONE
13-SEP-95 (SUSPENSION/ TAMPA, FL 0.1%
DROPS) 33637 NEOMYCIN SULFATE
EQ 3.5MG BASE/ML
POLYMYXIN B SULFATE
10,000 UNIT/ML
(STEROID/ANTIBIOTIC)
74-454 ALBUTEROL SULFATE BARRE ALBUTEROL SULFATE
25-SEP-95 (SYRUP) BALTIMORE, MD EQ 2MG BASE/5ML
21224 (BETA-2 AGONIST)
81-054 HYDROXYZINE HCL SIDMAK LABS HYDROXYZINE HYDROCHLORIDE
25-SEP-95 (TABLET) EAST HANOVER, NJ 100MG
07936 (ANXIOLYTIC/ANTIPRURITIC)
73-533 ALBUTEROL SULFATE PACO ALBUTEROL SULFATE
26-SEP-95 (SOLUTION) LAKEWOOD, NJ EQ 0.083% BASE
08701 (BETA-2 AGONIST)
74-376 DICLOFENAC SODIUM GENEVA PHARMS DICLOFENAC SODIUM
28-SEP-95 (TABLET, BROOMFIELD, CO 25MG
DELAYED RELEASE) 80038 50MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
40-074 PROPARACAINE HCL BAUSCH AND LOMB PROPARACAINE HYDROCHLORIDE
29-SEP-95 (SOLUTION/DROPS) TAMPA, FL 0.5%
33637 (LOCAL ANESTHETIC-
OPHTHALMIC)
40-094 HYDROCODONE WATSON LABS ACETAMINOPHEN
29-SEP-95 BITARTRATE AND CORONA, CA 650MG
ACETAMINOPHEN 91720 HYDROCODONE BITARTRATE
(TABLET) 7.5MG
(ANALGESIC)
40-094 HYDROCODONE WATSON LABS ACETAMINOPHEN
29-SEP-95 BITARTRATE AND CORONA, CA 650MG
ACETAMINOPHEN 91720 HYDROCODONE BITARTRATE
(TABLET) 10MG
(ANALGESIC)
40-113 CHLORZOXAZONE AMIDE PHARM CHLORZOXAZONE
29-SEP-95 (TABLET) LITTLE FALLS, NJ 500MG
07424 (SKELETAL MUSCLE RELAXANT)
74-382 AKPRO AKORN DIPIVEFRIN HYDROCHLORIDE
29-SEP-95 (SOLUTION/DROPS) ABITA SPRINGS, LA 0.1%
70420 (ANTIGLAUCOMA)
74-421 CYCLOBENZAPRINE HCL SIDMAK LABS NJ CYCLOBENZAPRINE
29-SEP-95 (TABLET) EAST HANOVER, NJ HYDROCHLORIDE
07936 10MG
(SKELETAL MUSCLE RELAXANT)
74-458 MEGESTROL ACETATE ROXANE MEGESTROL ACETATE
29-SEP-95 (TABLET) COLUMBUS, OH 20MG
43216 40MG
(PROGESTERONE DERIVATIVE)
74-460 PIROXICAM ROYCE LABS PIROXICAM
29-SEP-95 (CAPSULE) MIAMI, FL 10MG
33014 20MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-615 GEMFIBROZIL INVAMED GEMFIBROZIL
29-SEP-95 (TABLET) DAYTON, NJ 600MG
08810 (ANTIHYPERLIPIDEMIC)
***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.
74-483 CAPTOPRIL LEMMON CAPTOPRIL
29-SEP-95 (TABLET) SELLERSVILLE, PA 12.5MG
18960 25MG
50MG
100MG
ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
20-036 AREDIA CIBA GEIGY PAMIDRONATE DISODIUM
01-SEP-95 (INJECTABLE) SUMMIT, NJ 30MG/VIAL
07901 60MG/VIAL
90MG/VIAL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
20-136 DEMADEX BOEHRINGER MANNHEIM TORSEMIDE
05-SEP-95 (TABLET) GAITHERSBURG, MD 5MG
20878 10MG
20MG
100MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
DOSAGE AND ADMINISTRATION)
20-137 DEMADEX BOEHRINGER MANNHEIM TORSEMIDE
05-SEP-95 (INJECTABLE) GAITHERSBURG, MD 10MG/ML
20878 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
DOSAGE AND ADMINISTRATION)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
07-SEP-95 (TABLET) WILMINGTON, DE 1MG
19805 2MG
2.5MG
4MG
5MG
7.5MG
10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
07-SEP-95 (INJECTABLE) WILMINGTON, DE 5MG/VIAL
19805 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
10-971 PMB 200 WYETH AYERST CONJUGATED ESTROGENS
07-SEP-95 (TABLET) PHILADELPHIA, PA 0.45MG
19101 MEPROBAMATE
200MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS)
10-971 PMB 400 WYETH AYERST CONJUGATED ESTROGENS
07-SEP-95 (TABLET) PHILADELPHIA, PA 0.45MG
19101 MEPROBAMATE
400MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS)
12-541 DEPO-PROVERA UPJOHN MEDROXYPROGESTERONE ACETATE
07-SEP-95 (INJECTABLE) KALAMAZOO, MI 100MG/ML
49001 400MG/ML
(LABELING REVISION --
WARNINGS)
18-936 PROZAC LILLY FLUOXETINE HYDROCHLORIDE
12-SEP-95 (CAPSULE) INDIANAPOLIS, IN EQ 10MG BASE
46285 EQ 20MG BASE
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
ADVERSE REACTIONS)
20-101 PROZAC LILLY FLUOXETINE HYDROCHLORIDE
12-SEP-95 (SOLUTION) INDIANAPOLIS, IN EQ 20MG BASE/5ML
46285 (LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
ADVERSE REACTIONS)
50-588 CEFOTAN ZENECA CEFOTETAN DISODIUM
12-SEP-95 (INJECTABLE) WILMINGTON, DE EQ 1GM BASE/VIAL
19850 EQ 2GM BASE/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
PREPARATION OF SOLUTION;
COMPATIBILITY AND STABILITY
HOW SUPPLIED)
50-585 ROCEPHIN ROCHE CEFTRIAXONE SODIUM
14-SEP-95 (INJECTABLE) NUTLEY, NJ EQ 10GM BASE/VIAL
07110 (LABELING REVISION --
SEPARATE PACKAGE INSERT
FOR PHARMACY BULK PACKAGE)
18-554 EULEXIN SCHERING FLUTAMIDE
14-SEP-95 (CAPSULE) KENILWORTH, NJ 125MG
07033 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
20-210 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE
15-SEP-95 (TABLET) PISCATAWAY, NJ EQ 10MG BASE
08855 EQ 20MG BASE
(LABELING REVISION --
BOXED WARNING;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
16-640 QUESTRAN BRISTOL MYERS CHOLESTYRAMINE
22-SEP-95 (POWDER) EVANSVILLE, IN EQ 4GM RESIN/PACKET
47721 EQ 4GM RESIN/SCOOPFUL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
17-563 FLAVORED COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (GRANULE) KALAMAZOO, MI 5GM/PACKET
49001 5GM/SCOOPFUL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
17-563 COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (GRANULE) KALAMAZOO, MI 5GM/PACKET
49001 5GM/SCOOPFUL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-081 ESTRADERM CIBA ESTRADIOL
22-SEP-95 (FILM, SUMMIT, NJ 0.05MG/24HR
EXTENDED 07901 0.1MG/24HR
RELEASE) (LABELING REVISION --
PRECAUTIONS)
19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC
22-SEP-95 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL
46285 (LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION)
19-669 QUESTRAN LIGHT BRISTOL MYERS CHOLESTYRAMINE
22-SEP-95 (POWDER) EVANSVILLE, IN EQ 4GM RESIN/PACKET
47721 EQ 4GM RESIN/SCOOPFUL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
20-222 COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (TABLET) KALAMAZOO, MI 1GM
49001 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-884 MESNEX ASTA MESNA
25-SEP-95 (INJECTABLE) FRANKFURT, GERMANY 100MG/ML
(LABELING REVISION --
WARNINGS)
20-062 CARDIZEM CD MARION MERRELL DOW DILTIAZEM HYDROCHLORIDE
25-SEP-95 (CAPSULE) HAMILTON HM DX 120MG
BERMUDA 180MG
240MG
300MG
(LABELING REVISION --
PRECAUTIONS; HOW SUPPLIED)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
07-SEP-95 (TABLET) WILMINGTON, DE 1MG
19805 2MG
2.5MG
4MG
5MG
7.5MG
10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
07-SEP-95 (INJECTABLE) WILMINGTON, DE 5MG/VIAL
19805 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
10-971 PMB 200 WYETH AYERST CONJUGATED ESTROGENS
07-SEP-95 (TABLET) PHILADELPHIA, PA 0.45MG
19101 MEPROBAMATE
200MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS)
10-971 PMB 400 WYETH AYERST CONJUGATED ESTROGENS
07-SEP-95 (TABLET) PHILADELPHIA, PA 0.45MG
19101 MEPROBAMATE
400MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS)
12-541 DEPO-PROVERA UPJOHN MEDROXYPROGESTERONE ACETATE
07-SEP-95 (INJECTABLE) KALAMAZOO, MI 100MG/ML
49001 400MG/ML
(LABELING REVISION --
WARNINGS)
18-936 PROZAC LILLY FLUOXETINE HYDROCHLORIDE
12-SEP-95 (CAPSULE) INDIANAPOLIS, IN EQ 10MG BASE
46285 EQ 20MG BASE
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
ADVERSE REACTIONS)
20-101 PROZAC LILLY FLUOXETINE HYDROCHLORIDE
12-SEP-95 (SOLUTION) INDIANAPOLIS, IN EQ 20MG BASE/5ML
46285 (LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
ADVERSE REACTIONS)
50-588 CEFOTAN ZENECA CEFOTETAN DISODIUM
12-SEP-95 (INJECTABLE) WILMINGTON, DE EQ 1GM BASE/VIAL
19850 EQ 2GM BASE/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
PREPARATION OF SOLUTION;
COMPATIBILITY AND STABILITY
HOW SUPPLIED)
50-585 ROCEPHIN ROCHE CEFTRIAXONE SODIUM
14-SEP-95 (INJECTABLE) NUTLEY, NJ EQ 10GM BASE/VIAL
07110 (LABELING REVISION --
SEPARATE PACKAGE INSERT
FOR PHARMACY BULK PACKAGE)
18-554 EULEXIN SCHERING FLUTAMIDE
14-SEP-95 (CAPSULE) KENILWORTH, NJ 125MG
07033 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
20-210 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE
15-SEP-95 (TABLET) PISCATAWAY, NJ EQ 10MG BASE
08855 EQ 20MG BASE
(LABELING REVISION --
BOXED WARNING;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
16-640 QUESTRAN BRISTOL MYERS CHOLESTYRAMINE
22-SEP-95 (POWDER) EVANSVILLE, IN EQ 4GM RESIN/PACKET
47721 EQ 4GM RESIN/SCOOPFUL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
17-563 FLAVORED COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (GRANULE) KALAMAZOO, MI 5GM/PACKET
49001 5GM/SCOOPFUL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
17-563 COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (GRANULE) KALAMAZOO, MI 5GM/PACKET
49001 5GM/SCOOPFUL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-081 ESTRADERM CIBA ESTRADIOL
22-SEP-95 (FILM, SUMMIT, NJ 0.05MG/24HR
EXTENDED 07901 0.1MG/24HR
RELEASE) (LABELING REVISION --
PRECAUTIONS)
19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC
22-SEP-95 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL
46285 (LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION)
19-669 QUESTRAN LIGHT BRISTOL MYERS CHOLESTYRAMINE
22-SEP-95 (POWDER) EVANSVILLE, IN EQ 4GM RESIN/PACKET
47721 EQ 4GM RESIN/SCOOPFUL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
20-222 COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (TABLET) KALAMAZOO, MI 1GM
49001 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-884 MESNEX ASTA MESNA
25-SEP-95 (INJECTABLE) FRANKFURT, GERMANY 100MG/ML
(LABELING REVISION --
WARNINGS)
20-062 CARDIZEM CD MARION MERRELL DOW DILTIAZEM HYDROCHLORIDE
25-SEP-95 (CAPSULE) HAMILTON HM DX 120MG
BERMUDA 180MG
240MG
300MG
(LABELING REVISION --
PRECAUTIONS; HOW SUPPLIED)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
07-SEP-95 (TABLET) WILMINGTON, DE 1MG
19805 2MG
2.5MG
4MG
5MG
7.5MG
10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
07-SEP-95 (INJECTABLE) WILMINGTON, DE 5MG/VIAL
19805 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
10-971 PMB 200 WYETH AYERST CONJUGATED ESTROGENS
07-SEP-95 (TABLET) PHILADELPHIA, PA 0.45MG
19101 MEPROBAMATE
200MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS)
10-971 PMB 400 WYETH AYERST CONJUGATED ESTROGENS
07-SEP-95 (TABLET) PHILADELPHIA, PA 0.45MG
19101 MEPROBAMATE
400MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS)
12-541 DEPO-PROVERA UPJOHN MEDROXYPROGESTERONE ACETATE
07-SEP-95 (INJECTABLE) KALAMAZOO, MI 100MG/ML
49001 400MG/ML
(LABELING REVISION --
WARNINGS)
18-936 PROZAC LILLY FLUOXETINE HYDROCHLORIDE
12-SEP-95 (CAPSULE) INDIANAPOLIS, IN EQ 10MG BASE
46285 EQ 20MG BASE
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
ADVERSE REACTIONS)
20-101 PROZAC LILLY FLUOXETINE HYDROCHLORIDE
12-SEP-95 (SOLUTION) INDIANAPOLIS, IN EQ 20MG BASE/5ML
46285 (LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
ADVERSE REACTIONS)
50-588 CEFOTAN ZENECA CEFOTETAN DISODIUM
12-SEP-95 (INJECTABLE) WILMINGTON, DE EQ 1GM BASE/VIAL
19850 EQ 2GM BASE/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
PREPARATION OF SOLUTION;
COMPATIBILITY AND STABILITY
HOW SUPPLIED)
50-585 ROCEPHIN ROCHE CEFTRIAXONE SODIUM
14-SEP-95 (INJECTABLE) NUTLEY, NJ EQ 10GM BASE/VIAL
07110 (LABELING REVISION --
SEPARATE PACKAGE INSERT
FOR PHARMACY BULK PACKAGE)
18-554 EULEXIN SCHERING FLUTAMIDE
14-SEP-95 (CAPSULE) KENILWORTH, NJ 125MG
07033 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
20-210 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE
15-SEP-95 (TABLET) PISCATAWAY, NJ EQ 10MG BASE
08855 EQ 20MG BASE
(LABELING REVISION --
BOXED WARNING;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
16-640 QUESTRAN BRISTOL MYERS CHOLESTYRAMINE
22-SEP-95 (POWDER) EVANSVILLE, IN EQ 4GM RESIN/PACKET
47721 EQ 4GM RESIN/SCOOPFUL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
17-563 FLAVORED COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (GRANULE) KALAMAZOO, MI 5GM/PACKET
49001 5GM/SCOOPFUL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
17-563 COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (GRANULE) KALAMAZOO, MI 5GM/PACKET
49001 5GM/SCOOPFUL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-081 ESTRADERM CIBA ESTRADIOL
22-SEP-95 (FILM, SUMMIT, NJ 0.05MG/24HR
EXTENDED 07901 0.1MG/24HR
RELEASE) (LABELING REVISION --
PRECAUTIONS)
19-640 HUMATROPE LILLY SOMATROPIN, BIOSYNTHETIC
22-SEP-95 (INJECTABLE) INDIANAPOLIS, IN 5MG/VIAL
46285 (LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION)
19-669 QUESTRAN LIGHT BRISTOL MYERS CHOLESTYRAMINE
22-SEP-95 (POWDER) EVANSVILLE, IN EQ 4GM RESIN/PACKET
47721 EQ 4GM RESIN/SCOOPFUL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
20-222 COLESTID UPJOHN COLESTIPOL HYDROCHLORIDE
22-SEP-95 (TABLET) KALAMAZOO, MI 1GM
49001 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DRUG INTERACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-884 MESNEX ASTA MESNA
25-SEP-95 (INJECTABLE) FRANKFURT, GERMANY 100MG/ML
(LABELING REVISION --
WARNINGS)
20-062 CARDIZEM CD MARION MERRELL DOW DILTIAZEM HYDROCHLORIDE
25-SEP-95 (CAPSULE) HAMILTON HM DX 120MG
BERMUDA 180MG
240MG
300MG
(LABELING REVISION --
PRECAUTIONS; HOW SUPPLIED)
P800036/S015 INFUSAID MODEL 400 STRATO/INFUSAID, INC CHANGE IN LABELING
09/20/95 IMPLANTABLE INFUSION NORWOOD, MA ADDS EPIDURAL AND
PUMP FOR THE 02062 INTRATHECAL
DELIVERY OF ADMINISTRATION OF
INFUMORPH 200 INFUMORPH 200 AND 500
CII
AND 500 CII
(PRESERVATIVE-FREE
MORPHINE SULFATE
10MG/ML AND 25MG/ML)
P810006/S019 COLLASTAT VITAPHORE, CORP ALTERNATE STERILIZATION
09/12/95 MICROFIBRILLAR PLAINSBORO, NJ FACILITY FOR COLLASTAT
HEMOSTATIC SPONGE 08536 MICROFIBRILLAR
HEMOSTATIC SPONGE AT
GLEN FALLS, NY 12801
P820036/S013 OPTI-CLEAN DAILY ALCON LABORATORIES, INC CHANGES IN
09/08/95 CLEANER FORT WORTH, TX MANUFACTURING PROCESS
76134-2099 TO ELIMINATE AIR BLOWING
EMPTY BOTTLES AND INCLUDE
SPECIFICATIONS TO
CONTROL PARTICULATE
LEVELS
P820076/S017 PMS 600 BIOTRONIK, INC APPROVAL FOR THE SWM
09/07/95 PROGRAMMER WITH LAKE OSWEGO, OR 600 VERSION DO5UO1
SWM 600 VERSION 97035-5369 SOFTWARE MODULE FOR
DO5UO1 SOFTWARE USE WITH THE MODEL
MODULE PMS 600 PROGRAMMER
P830034/S027 OPTI-ONE ALCON LABORATORIES, INC EXPAND THE INDICATIONS
09/26/95 MULTI-PURPOSE FORT WORTH, TX FOR USE TO ALL CLEAR
SOLUTION 76134-2099 AND TINTED DAILY AND
CONTACT LENSES
P830034/S028 OPTI-CLEAN II ALCON LABORATORIES, INC CHANGES IN
09/08/95 DAILY CLEANER, FORT WORTH, TX MANUFACTURING PROCESS
OPTI-FREE DAILY 76134-2099 TO ELIMINATE AIR BLOWING
CLEANER, OF EMPTY BOTTLES AND
OPTI-FREE INCLUDE SPECIFICATIONS
REWETTING DROPS, TO CONTROL PARTICULATE
OPTI-TEARS LEVELS
SOOTHING DROPS
P840062/S006 COLLACOTE, COLLA-TEC, INC ALTERNATE STERILIZATION
09/08/95 COLLATAPE, PLAINSBORO, NJ FACILITY AT GLEN FALLS,
AND COLLAPLUG 08536 NY 12801
DRESSINGS
P850010/S015 HELISTAT COLLA-TEC, INC ALTERNATE STERILIZATION
09/12/95 ABSORBABLE COLLAGEN PLAINSBORO, NJ FACILITY FOR HELISTAT
HEMOSTATIC AGENT 08536 ABSORBABLE COLLAGEN
HEMOSTATIC AGENT AT
GLEN FALLS, NY 12801
P850057/S005 SOFTMATE PILKINGTON BARNES HIND ALTERNATE
09/22/95 CUSTOMEYES SUNNYVALE, CA MANUFACTURING PROCESS
(BUFILCON A, 94086 USING ULTRAVIOLET
55% WATER) LIGHT INITIATOR IN
SOFT (HYDROPHILIC) MODIFIED CURE PROCESS
CONTACT LENS FOR FOR BUFILCON A
EXTENDED WEAR (55% WATER) CONTACT
LENSES
P860027/S010 MAESTRO II CARDIAC CONTROL SYSTEMS, INC APPROVAL FOR THE
09/26/95 MODEL 533 PALM COAST, FL MAESTRO II MODEL 533
PACEMAKER SYSTEM 32164 PACEMAKER SYSTEM
P870007/S009 SORBIC ACID OPTOPICS LABORATORIES, CORP MODIFICATION OF THE
9/20/95 PRESERVED STERILE FAIRTON, NJ STABILITY
SALINE FOR SOFT 08320 SPECIFICATIONS FOR
CONTACT LENSES SORBIC ACID
CONCENTRATION
P870015/S021 MEDSTONE STS MEDSTONE ALTERNATE ULTRASOUND
09/15/95 EXTRACORPOREAL INTERNATIONAL, INC IMAGING UNIT,
SHOCK WAVE ALISO VIEJO, CA ALTERNATE DIGITIZER
LITHOTRIPTER 92656-4114 PAD, MODIFIED
SYSTEM SOFTWARE,
REVISION TO USER'S MANUAL
P880003/S049 CORDIS PTCA CORDIS, CORP NEW PACKAGING
09/18/95 DILATATION CATHETERS MIAMI, FL TRAY MATERIAL
33102-5700 (ACRYLIC XT POLYMER)
P880011/S003 SONOLITH 2000 EDAP TECHNOMED GROUP MANUFACTURING SITE
09/06/95 (USA), INC CHANGE TO BRON,
CAMBRIDGE, MA FRANCE TO MANUFACTURE
02139 THE SOLOLITH 2000 AND
3000 EXTRACORPOREAL
SHOCK WAVE LITHOTRIPTERS
P880082/S018 INTRAOCULAR LENSES EYE TECHNOLOGY, INC USE OF NEW CLEANING AGENT
09/28/95 ST PAUL, MN
55117
P890057/S003 MODEL 3100/3100A SENSORMEDICS, CORP INDICATED FOR THE
09/15/95 HIGH FREQUENCY YORBA LINDA, CA TREATMENT OF NEONATES
OSCILLATORY 92687 WHO HAVE RESPIRATORY
VENTILATOR FAILURE AND SELECTED
PEDIATRIC PATIENTS
WHO ARE FAILING
CONVENTIONAL VENTILATION
P930035/S001 VENTAK P3, CARDIAC PACEMAKERS, INC NEW SOFTWARE MODULES,
09/08/95 MODELS 1630 AND ST PAUL, MN PATCH LEADS CONNECTORS,
1635 ACID SYSTEM 55112-5798 AND ALTERNATE
STERILIZATION METHOD
USING OXYFUME
***ORIGINAL VETERINARY NADAs***
141-042 IMMITICIDE DOGS RHONE MERIEUX MELARSOMINE
21-JUL-95 (POWDER) ATHENS, GA DIHYDROCHLORIDE
30601 50MG/VIAL
141-052 OPTIMMUNE DOGS SCHERING PLOUGH CYCLOSPORINE
02-AUG-95 (OINTMENT) AN HLTH 2MG/GM
KENILWORTH, NJ
07033
141-017 SARAFLOX WSP BROILER ABBOTT LABS SARAFLOXACIN
18-AUG-95 (POWDER) CHICKENS, N CHICAGO, IL HYDROCHLORIDE
TURKEYS 60064 145GM/PACKAGE
***ORIGINAL ABBREVIATED VETERINARY NADAs***
200-068 OXYTETRACYCLINE CATTLE PHOENIX PHARMA OXYTETRACYCLINE
31-JUL-95 HYDROCHLORIDE ST JOSEPH, MO HYDROCHLORIDE
(INJECTABLE) 64506 100MG/ML
200-023 GENTAMICIN SULFATE HORSES FERMENTA AN HLTH GENTAMICIN SULFATE
04-AUG-95 (SOLUTION) KANSAS CITY, MO 100MG/ML
64153
200-029 KETAMINE CATS, FERMENTA AN HLTH KETAMINE
16-AUG-95 HYDROCHLORIDE SUBHUMAN KANSAS CITY, MO HYDROCHLORIDE
(INJECTABLE) PRIMATES 64153 100MG/ML
200-142 FLUNIXIN MEGLUMINE HORSES FT DODGE LABS FLUNIXIN MEGLUMINE
18-AUG-95 (SOLUTION) FT DODGE, IA 50MG/ML
50501
***SUPPLEMENTAL VETERINARY NADAs***
140-915 INTERCEPTOR OXIME DOGS CIBA GEIGY AN HLTH MILBEMYCIN OXIME
16-AUG-95 (TABLET) GREENSBORO, NC 2.3MG
27419 5.75MG
11.5MG
23MG
Date created: October 30, 1996; last updated: June 20, 2005 |
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