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Drug and Device Product Approvals for February 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-123 OMNISCAN NYCOMED GADODIAMIDE
05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML
(SUPPL-004) 19087 (NEW DOSAGE REGIMEN --
INCREASE OF CUMULATIVE
DOSE TO 0.3MMOL/KG FOR
MRI OF THE CNS IN
ADULTS)
20-123 OMNISCAN NYCOMED GADODIAMIDE
05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML
(SUPPL-005) 19087 (NEW INDICATION --
ENHANCEMENT OF MRI OF
THE ADULT BODY INTERNAL
ORGANS)
20-123 OMNISCAN NYCOMED GADODIAMIDE
05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML
(SUPPL-007) 19087 (NEW INDICATION --
0.1MMOL/KG AS A SINGLE
INTRAVENOUS BOLUS FOR
MRI OF THE CNS IN
CHILDREN)
18-612 NICORETTE SMITHKLINE BEECHAM NICOTINE POLACRILEX
09-FEB-96 (GUM, CHEWING) PARSIPPANY, NJ EQ 2MG BASE
(SUPPL-007) 07054 (RX TO OTC SWITCH)
(OTC)
19-501 ROGAINE UPJOHN MINOXIDIL
09-FEB-96 (SOLUTION) KALAMAZOO, MI 2%
(SUPPL-012) 49001 (RX TO OTC
SWITCH)
(OTC)
20-066 NICORETTE SMITHKLINE BEECHAM NICOTINE POLACRILEX
09-FEB-96 (GUM, CHEWING) PARSIPPANY, NJ EQ 4MG BASE
(SUPPL-004) 07054 (RX TO OTC SWITCH)
(OTC)
20-372 MYOVIEW MEDI PHYSICS TECHNETIUM TC-99M
09-FEB-96 (INJECTABLE) ARLINGTON HEIGHTS, IL TETROFOSMIN KIT
(1 S) 60005 N/A
(RADIOACTIVE DIAGNOSTIC)
[SCINTIGRAPHIC IMAGING
OF THE MYOCARDIUM
FOLLOWING SEPARATE
ADMINISTRATIONS
UNDER EXERCISE AND
RESTING CONDITIONS. IT
IS USEFUL IN THE
DELINEATION OF REGIONS
OF REVERSIBLE MYOCARDIAL
ISCHEMIA IN THE PRESENCE
OR ABSENCE OF INFARCTED
MYOCARDIUM]
11-522 ADDERALL 10 RICHWOOD PHARM AMPHETAMINE ASPARTATE
13-FEB-96 (TABLET) FLORENCE, KY 2.5MG
(SUPPL-010) 41042 AMPHETAMINE SULFATE
2.5MG
DEXTROAMPHETAMINE
SACCHARATE
DEXTROAMPHETAMINE
SULFATE
2.5MG
(AMPHETAMINE)
11-522 ADDERALL 20 RICHWOOD PHARM AMPHETAMINE ASPARTATE
13-FEB-96 (TABLET) FLORENCE, KY 5MG
(SUPPL-010) 41042 AMPHETAMINE SULFATE
5MG
DEXTROAMPHETAMINE
SACCHARATE
5MG
DEXTROAMPHETAMINE
SULFATE
5MG
(AMPHETAMINE)
50-720 AUGMENTIN '875' SMITHKLINE BEECHAM AMOXICILLIN
13-FEB-96 (TABLET) PHILADELPHIA, PA
875MG
(3 S) 19101 (ANTIBIOTIC, PENICILLIN)
CLAVULANATE POTASSIUM
EQ 125MG BASE
(BETA LACTAMASE
ENZYME INACTIVATOR)
50-443 BLENOXANE BRISTOL MYERS SQUIBB BLEOMYCIN SULFATE
20-FEB-96 (INJECTABLE) PRINCETON, NJ EQ 15 UNITS BASE/VIAL
(SUPPL-025) 08543 (NEW INDICATION --
SCLEROSING AGENT FOR THE
TREATMENT OF MALIGNANT
PLEURAL EFFUSION AND
PREVENTION OF RECURRENT
PLEURAL EFFUSIONS)
20-552 COVERA-HS
SEARLE VERAPAMIL HYDROCHLORIDE
26-FEB-96 (TABLET, SKOKIE, IL 180MG
(5 S) EXTENDED RELEASE) 60077 240MG
(CALCIUM ION
INFLUX INHIBITOR)
[HYPERTENSION, ANGINA]
20-144 TRANSDERM-NITRO CIBA NITROGLYCERIN
(SUPPL-002, (FILM, SUMMIT, NJ 0.1MG/HR
003, 005, EXTENDED RELEASE) 07901 0.2MG/HR
007, 008) 0.4MG/HR
0.6MG/HR
0.8MG/HR
(VASODILATOR)
[PREVENTION OF ANGINA
PECTORIS DUE TO CORONARY
ARTERY DISEASE]
19-596 MAGNEVIST BERLEX GADOPENTETATE
28-FEB-96 (INJECTABLE) WAYNE, NJ DIMEGLUMINE
(SUPPL-009) 07470 469.01MG/ML
(NEW INDICATION --
CONTRAST ENHANCEMENT AND
FACILITATION OF
VISUALIZATION OF
EXTRACRANIAL HEAD AND
NECK LESIONS)
20-479 GASTROCROM FISONS CROMOLYN SODIUM
29-FEB-96 (CONCENTRATE) ROCHESTER, NY 100MG/5ML
(3 S) 14603 (MAST CELL STABILIZER)
[MANAGEMENT OF PATIENTS
WITH MASTOCYTOSIS]
***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.
20-416 FERIDEX ADVANCED MAGNETICS FERUMOXIDES
02-FEB-96 (INJECTABLE) CAMBRIDGE, MA EQ 11.2MG IRON/ML
02138 EQ 61.3MG MANNITOL/ML
(MRI CONTRAST MEDIUM)
20-405 LANOXIN GLAXO WELLCOME DIGO
XIN
14-FEB-96 (TABLET) RES TRIANGLE PARK, NC 0.0625MG
27709 0.125MG
0.1875MG
0.25MG
0.375MG
0.5MG
(CARDIAC GLYCOSIDE)
20-495 RELAFEN SMITHKLINE BEECHAM NABUMETONE
16-FEB-96 (TABLET, CHEWABLE) KING OF PRUSSIA, PA 1GM
19406 (NONSTEROIDAL
ANTI-INFLAMMATORY)
20-572 AMMONAPSE UCYCLYD SODIUM PHENYLBUTYRATE
16-FEB-96 (TABLET) HUNT VALLEY, MD 500MG
21031 (ENZYME REPLENISHER)
20-573 AMMONAPSE UCYCLYD SODIUM PHENYLBUTYRATE
16-FEB
-96 (POWDER) HUNT VALEY, MD 250GM/BOTTLE
21031 (ENZYME REPLENISHER)
20-169 NILANDRON BESSELAAR ASSOC NILUTAMIDE
22-FEB-96 (TABLET) PRINCETON, NJ 50MG
08540 (NONSTEROIDAL
ANTIANDROGEN)
20-450 CEREBYX WARNER LAMBERT FOSPHENYTOIN SODIUM
23-FEB-96 (INJECTABLE) ANN ARBOR, MI EQ 50MG PHENYTOIN/ML
48106 (ANTICONVULSANT)
***ORIGINAL ABBREVIATED NDAs***
74-430 DESIPRAMINE HCL EON LABS DESIPRAMINE
09-FEB-96 (TABLET) LAURELTON, NY HYDROCHLORIDE
11413 10MG
150MG
(ANTIDEPRESS
ANT)
74-322 CAPTOPRIL NOVOPHARM CAPTOPRIL
13-FEB-96 (TABLET) SCARBOROUGH, ONTARIO 12.5MG
CANADA M1B2K9 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-418 CAPTOPRIL ENDO LABS CAPTOPRIL
13-FEB-96 (TABLET) GARDEN CITY, NY 12.5MG
11530 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-423 CAPTOPRIL MOVA CAPTOPRIL
13-FEB-96 (TABLET)
CAGUAS, PR 12.5MG
00725 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-433 CAPTOPRIL BIOCRAFT CAPTOPRIL
13-FEB-96 (TABLET) FAIR LAWN, NJ 12.5MG
07410 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-434 CAPTOPRIL MYLAN CAPTOPRIL
13-FEB-96 (TABLET) MORGANTOWN, WV 12.5MG
26504 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-451 CAPTOPRIL ROYCE LABS CAPTOPRIL
13-FEB-96 (TABLET) MIAMI, FL 12.5MG
33014 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-462 CAPTOPRIL COPLEY PHARM CAPTOPRIL
13-FEB-96 (TABLET) CANTON, MA 12.5MG
02021 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-477 CAPTOPRIL HALLMARK PHARMS CAPTOPRIL
13-FEB-96 (TABLET) SOMERSET, NJ 12.5MG
08873 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-481 CAPTOPRIL INVAMED CAPTOPRIL
13-FEB-96 (TABLET) DAYTON, NJ 12.5MG
08810 25MG
50MG
100MG
(ANGIOTENSIN CONV
ERTING
ENZYME INHIBITOR)
74-483 CAPTOPRIL LEMMON CAPTOPRIL
13-FEB-96 (TABLET) SELLERSVILLE, PA 12.5MG
18960 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-493 CAPTOPRIL PAR PHARM CAPTOPRIL
13-FEB-96 (TABLET) SPRING VALLEY, NY 12.5MG
10977 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-505 C
APTOPRIL WESTWARD PHARM CAPTOPRIL
13-FEB-96 (TABLET) EATONTOWN, NJ 12.5MG
07724 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-519 CAPTOPRIL EON LABS CAPTOPRIL
13-FEB-96 (TABLET) LAURELTON, NY 12.5MG
11413 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-069* AZATHIOPRINE ROXANE AZATHIOPRINE
16-FEB-96 (TABLET) COLUMBUS, OH
50MG
43216 (IMMUNOSUPPRESSIVE)
* - First Time Product Available Generically
40-143 HYDROCODONE VINTAGE PHARMS ACETAMINOPHEN
22-FEB-96 BITARTRATE AND CHARLOTTE, NC 650MG
ACETAMINOPHEN 28206 HYDROCODONE BITARTRATE
(TABLET) 10MG
(ANALGESIC)
40-144 HYDROCODONE VINTAGE PHARMS ACETAMINOPHEN
22-FEB-96 BITARTRATE AND CHARLOTTE, NC 500MG
ACETAMINOPHEN 28206 HYDROCODONE BITARTRATE
(TABLET) 7.5MG
(ANALGESIC)
73-263* PREVALITE UPSHER SMITH CHOLESTYRAMINE
22-FEB-96 (POWDER) MINNEAPOLIS, MN EQ 4GM RESIN/PACKET
55447 (ANTIHYPERLI
PIDEMIC)
74-227 ETOPOSIDE PHARMACHEMIE (NL) ETOPOSIDE
22-FEB-96 (INJECTABLE) HAARLEM, NETHERLANDS 20MG/ML
(ANTINEOPLASTIC)
74-366 MICONAZOLE NITRATE G AND W LABS MICONAZOLE NITRATE
22-FEB-96 (CREAM) SOUTH PLAINFIELD, NJ 2%
07080 (ANTIFUNGAL)
(OTC)
40-024* DEXFERRUM LUITPOLD IRON DEXTRAN
23-FEB-96 (INJECTABLE) SHIRLEY, NY EQ 50MG IRON/ML
11967 (MINERAL REPLACEMENT)
72-751 VERAPAMIL HCL SIDMAK LABS NJ VERAPAMIL HYDROCHLORIDE
23-FEB-96 (TABLET) EAST HANOVER, NJ 40MG
07936 (CALCIUM ION
INFLUX INHIBITOR)
74-407 CLOBETASOL FOUGERA
CLOBETASOL PROPIONATE
23-FEB-96 PROPIONATE MELVILLE, NY 0.05%
(OINTMENT) 11747 (CORTICOSTEROID)
* - First Time Product Available Generically
74-316 CIMETIDINE DANBURY PHARMA CIMETIDINE
28-FEB-96 (TABLET) DANBURY, CT 800MG
06810 (HISTAMINE H2-RECEPTOR
ANTAGONIST)
74-617* DILTIAZEM HCL BEDFORD DILTIAZEM HYDROCHLORIDE
28-FEB-96 (INJECTABLE) BEDFORD, OH 5MG/ML
44146 (CALCIUM ION
INFLUX INHIBITOR)
* - First Time Product Available Generically
***ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVAL***
A tentative approval indicates that FDA has given an
abbreviated new drug
application (ANDA) or 505(b)(2) application provisional approval under the
terms of the Drug Price Competition and Patent Term Restoration Act. Such drug
products that are the subjects of tentative approvals may not be legally
marketed until the market exclusivity and/or patent term of the listed
reference drug product has expired. Final approval is also contingent upon
conditions and information available to FDA remaining acceptable. When the
application receives final approval, the product may be legally marketed. The
effective approval date will be listed in this publication and in the "Approved
Drug Products with Therapeutic Equivalence Evaluations" list published by FDA.
Additional information on these applications will become available to the
public when the applications receive final approval.
THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS
FOR FEBRUARY 1996
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
20-123 OMNIS
CAN NYCOMED GADODIAMIDE
05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML
19087 (LABELING REVISION --
INDICATIONS AND USAGE;
DOSAGE AND
ADMINISTRATION)
19-099 DOPAMINE HCL AND MCGAW DOPAMINE HYDROCHLORIDE
07-FEB-96 DEXTROSE 5% IRVINE, CA 80MG/100ML
(INJECTABLE) 92713 160MG/100ML
320MG/100ML
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
HOW SUPPLIED)
19-615 DOPAMINE HCL IN BAXTER DOPAMINE HYDROCHLORIDE
07-FEB-96 DEXTROSE 5% ROUND LAKE, IL 80MG/100ML
IN PLASTIC CONTAINER 60073 160MG/100ML
(INJECTABLE) 320MG/100ML
(LABELING REVISION --
CLINICAL PHARMACOLOGY)
20-145 NITRO-DUR SCHERING NITROGLYCERIN
07-FEB-96 (FILM, KENILWORTH, NJ 0.1MG/HR
EXTENDED RELEASE) 07033 0.2MG/HR
0.3MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
(LABELING REVISION --
PRECAUTIONS)
50-674 VANTIN UPJOHN CEFPODOXIME PROXETIL
07-FEB-96 (TABLET) KALAMAZOO, MI EQ 100MG BASE
49001 EQ 200MG BASE
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
10-699 LEUKERAN GLAXO WELLCOME CHLORAMBUCIL
09-FEB-96 (TABLET) RES TRIANGLE PK, NC 2MG
27709 (LABELING REVISION --
DESCRIPTION; WARNINGS;
ADVERSE REACTIONS;
HOW SUPPLIED)
18-230 MYCELEX-7 BAYER CLOTRIMAZOLE
09-FEB-96 (CREAM) WEST HAVEN, CT 1%
06516 (LABELING REVISION --
PATIENT PACKAGE
PAMPHLET; TUBE LABEL;
HANGER CARD)
(OTC)
18-240 TENORMIN ZENECA ATENOLOL
09-FEB-96 (TABLET) WILMINGTON, DE 25MG
19897 50MG
100MG
(LABELING REVI
SION --
WARNINGS)
18-612 NICORETTE SMITHKLINE BEECHAM NICOTINE POLACRILEX
09-FEB-96 (GUM, CHEWING) PARSIPPANY, NJ EQ 2MG BASE
07054 (LABELING REVISION --
RX TO OTC SWITCH)
(OTC)
18-760 TENORETIC 50 ZENECA ATENOLOL
09-FEB-96 (TABLET) WILMINGTON, DE 50MG
19897 CHLORTHALIDONE
25MG
(LABELING REVISION --
WARNINGS)
18-760 TENORETIC 100 ZENECA ATENOLOL
09-FEB-96 (TABLET) WILMINGTON, DE 100MG
19897
CHLORTHALIDONE
25MG
(LABELING REVISION --
WARNINGS)
19-501 ROGAINE UPJOHN MINOXIDIL
09-FEB-96 (SOLUTION) KALAMAZOO, MI 2%
49001 (LABELING REVISION --
RX TO OTC SWITCH)
(OTC)
19-643 MEVACOR MERCK LOVASTATIN
09-FEB-96 (TABLET) WEST POINT, PA 10MG
19486 20MG
40MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY)
19-937 ADENOCARD MEDCO RES
ADENOSINE
09-FEB-96 (INJECTABLE) RES TRIANGLE PARK, NC 3MG/ML
27709 (LABELING REVISION --
PRECAUTIONS)
20-066 NICORETTE SMITHKLINE BEECHAM NICOTINE POLACRILEX
09-FEB-96 (GUM, CHEWING) PARSIPPANY, NJ EQ 4MG BASE
07054 (LABELING REVISION --
RX TO OTC SWITCH)
(OTC)
11-522 ADDERALL 10 RICHWOOD PHARM AMPHETAMINE ASPARTATE
13-FEB-96 (TABLET) FLORENCE, KY 2.5MG
41042 AMPHETAMINE SULFATE
2.5MG
DEXTROAMPHETAMINE
SACCHARATE
2.5MG
DEXTROAMPHETAMINE
SULFATE
2.5MG
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE)
11-522 ADDERALL 20 RICHWOOD PHARM AMPHETAMINE ASPARTATE
13-FEB-96 (TABLET) FLORENCE, KY 5MG
41042 AMPHETAMINE SULFATE
5MG
DEXTROAMPHETAMINE
SACCHARATE
5MG
DEXTROAMPHETAMINE
SULFATE
5MG
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE)
50-560 CEFIZOX FUJISAWA CEFTIZOXIME SODIUM
13-FEB-96 (INJECTABLE) MELROSE PARK, IL EQ 500MG BASE/VIAL
60160 EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
(LABELING REVISION --
WARNINGS)
10-515 ISUPREL SANOFI WINTHROP ISOPROTE
RENOL HYDROCHLORIDE
14-FEB-96 (INJECTABLE) NEW YORK, NY 0.2MG/ML
10016 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY)
17-943 PROLOPRIM GLAXO WELLCOME TRIMETHOPRIM
14-FEB-96 (TABLET) RES TRIANGLE PARK, NC 100MG
27709 200MG
(LABELING REVISION --
ADVERSE REACTIONS)
20-301 ORTHO-CEPT JOHNSON RW DESOGESTREL
14-FEB-96 (TABLET-21 DAY) RARITAN, NJ 0.15MG
08869 ETHINYL ESTRADIOL
0.03MG
(LABELING REVISION --
WARNINGS;
PATIENT PACKAGE INSERT)
20-301 ORTHO-CEPT JOHNSON RW DESOGESTREL
14-FEB-96 (TABLET-28 DAY) RARITAN, NJ 0.15MG
08869 ETHINYL ESTRADIOL
0.03MG
(LABELING REVISION --
WARNINGS;
PATIENT PACKAGE INSERT)
20-035 ERGAMISOL JANSSEN LEVAMISOLE HYDROCHLORIDE
16-FEB-96 (TABLET) TITUSVILLE, NJ EQ 50MG BASE
08560 (LABELING REVISION --
ADVERSE REACTIONS)
50-564 AUGMENTIN '250' SMITHKLINE BEECHAM AMOXICILLIN
16-FEB-96 (TABLET) PHILADELPH
IA, PA 250MG
19101 CLAVULANATE POTASSIUM
EQ 125MG BASE
(LABELING REVISION --
WARNINGS)
50-564 AUGMENTIN '500' SMITHKLINE BEECHAM AMOXICILLIN
16-FEB-96 (TABLET) PHILADELPHIA, PA 500MG
19101 CLAVULANATE POTASSIUM
EQ 125MG BASE
(LABELING REVISION --
WARNINGS)
50-575 AUGMENTIN '125' SMITHKLINE BEECHAM AMOXICILLIN
16-FEB-96 (POWDER PHILADELPHIA, PA 125MG/5ML
FOR RECONSTITUTION) 19101 CLAVULANATE POTASSIUM
EQ 31.25MG BASE/5ML
(LABELING REVISION --
WARNINGS)
50-575 AUGMENTIN '250' SMITHKLINE BEECHAM AMOXICILLIN
16-FEB-96 (POWDER PHILADELPHIA, PA 250MG/5ML
FOR RECONSTITUTION) 19101 CLAVULANATE POTASSIUM
EQ 62.5MG BASE/5ML
(LABELING REVISION --
WARNINGS)
50-597 AUGMENTIN '125' SMITHKLINE BEECHAM AMOXICILLIN
16-FEB-96 (TABLET, CHEWABLE) KING OF PRUSSIA, PA 125MG
19406 CLAVULANATE POTASSIUM
EQ 31.25MG BASE
(LABELING REVISION --
WARNINGS)
50-597 AUGMENTIN '250' SMITHKLINE BEECHAM
AMOXICILLIN
16-FEB-96 (TABLET, CHEWABLE) KING OF PRUSSIA, PA 250MG
19406 CLAVULANATE POTASSIUM
EQ 62.5MG BASE
(LABELING REVISION --
WARNINGS)
20-064 MACROBID PROCTER AND GAMBLE NITROFURANTOIN
20-FEB-96 (CAPSULE) NORWICH, NY 75MG
13815 NITROFURANTOIN,
MACROCRYSTALLINE
25MG
(LABELING REVISION --
WARNINGS; ADVERSE
REACTIONS)
50-443 BLENOXANE BRISTOL MYERS SQUIBB BLEOMYCIN SULFATE
20-FEB-96 (INJECTABLE) PR
INCETON, NJ EQ 15 UNITS BASE/VIAL
08543 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
20-051 GLYNASE UPJOHN GLYBURIDE
21-FEB-96 (TABLET) KALAMAZOO, MI 1.5MG
49001 3MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY)
50-591 BACTROBAN SMITHKLINE BEECHAM MUPIROCIN
21-FEB-96 (OINTMENT) P
HILADELPHIA, PA 2%
19101 (LABELING REVISION --
PRECAUTIONS)
06-035 METHERGINE SANDOZ METHYLERGONOVINE MALEATE
22-FEB-96 (TABLET) EAST HANOVER, NJ 0.2MG
07936 (LABELING REVISION --
PRECAUTIONS)
06-035 METHERGINE SANDOZ METHYLERGONOVINE MALEATE
22-FEB-96 (INJECTABLE) EAST HANOVER, NJ 0.2MG/ML
07936 (LABELING REVISION --
PRECAUTIONS)
17-968 DEPO-TESTADIOL UPJOHN ESTRADIOL CYPIONATE
22-FEB-96 (INJECTABLE) KALAMAZOO, MI 2MG/ML
49001 TESTOSTERONE CYPIONATE
50MG/ML
(LABELING REVISION --
DRUG ABUSE AND
DEPENDENCE)
18-261 PITOCIN PARKE DAVIS OXYTOCIN
22-FEB-96 (INJECTABLE) MORRIS PLAINS, NJ 10 USP UNITS/ML
07950 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE)
20-388 NAVELBINE GLAXO WELLCOME VINORELBINE TARTRATE
22-FEB-96 (INJECTABLE) RES TRIANGLE PARK, NC EQ 10MG BASE/ML
27709 (LABELING REVISION --
ADVERSE REACTIONS)
18-439 MVC PLUS STERIS ASCORBIC AC
ID
26-FEB-96 (INJECTABLE) PHOENIX, AZ 10MG/ML
85063 BIOTIN
0.006MG/ML
CYANOCOBALAMIN
0.5UGM/ML
DEXPANTHENOL
1.5MG/ML
ERGOCALCIFEROL
20 IU/ML
FOLIC ACID
0.04MG/ML
NIACINAMIDE
4MG/ML
PYRIDOXINE HYDROCHLORIDE
0.4MG/ML
RIBOFLAVIN PHOSPHATE
SODIUM
0.36MG/ML
THIAMINE HYDROCHLORIDE
0.3MG/ML
VITAMIN A
330 UNITS/ML
VITAMIN E
1 IU/ML
(LABELING REVISION --
ADVERSE REACTIONS)
17-831 DIDRONEL PROCTER GMBL PHARMS ETIDRONATE DISODIUM
27-FEB-96 (TABLET) NORWICH, NY 200MG
13815 400MG
(LABELING REVISION -
-
CLINICAL PHARMACOLOGY)
18-110 THALLOUS MEDI PHYSICS THALLOUS CHLORIDE, TL 201
27-FEB-96 CHLORIDE TL 201 ARLINGTON HEIGHTS, IL 1MCI/ML
(INJECTABLE) 60005 (LABELING REVISION --
ADVERSE REACTIONS)
19-617 PREPIDIL UPJOHN DINOPROSTONE
27-FEB-96 (GEL) KALAMAZOO, MI 0.5MG/3GM
49001 (LABELING REVISION --
CONTRAINDICATIONS;
PRECAUTIONS)
20-154 VIDEX BRISTOL-MYERS SQUIBB DIDANOSINE
27-FEB-96 (TABLET, CHEWABLE) WALLINGFORD, CT 25MG
06492 50MG
100MG
150MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY)
50-590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM
27-FEB-96 (INJECTABLE) PHILADELPHIA, PA EQ 100MG BASE/VIAL
19101 TICARCILLIN DISODIUM
EQ 3GM BASE/VIAL
(LABELING REVISION --
WARNINGS; DRUG ABUSE AND
DEPENDENCE; OVERDOSAGE;
HOW SUPPLIED)
50-590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM
27-FEB-96 (INJECTABLE) PHILADELPHIA, PA EQ 1GM BASE/VIAL
19101 TICARCILLIN DISODIUM
EQ 30GM BASE/VIAL
(LABELING REVISION --
WARNINGS;
DRUG ABUSE AND DEPENDENCE;
OVERDOSAGE;
HOW SUPPLIED)
50-658 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM
27-FEB-96 IN PLASTIC CONTAINER PHILADELPHIA, PA EQ 100MG BASE/100ML
(INJECTABLE) 19101 TICARCILLIN DISODIUM
EQ 3GM BASE/100ML
(LABELING REVISION --
WARNINGS; DRUG ABUSE
AND DEPENDENCE;
OVERDOSAGE; HOW
SUPPLIED)
08-303 APRESOLINE CIBA HYDRALAZINE
28-FEB-96 (TABLET) SUMMIT, NJ HYDROCHLORIDE
07901 10MG
25MG
50MG
100MG
(LABELING REVISION --
PRECAUTIONS;
HOW SUPPLIED)
19-596 MAGNEVIST BERLEX GADOPENTETATE
28-FEB-96 (INJECTABLE) WAYNE, NJ DIMEGLUMINE
07470 469.01MG/ML
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
CARCINOGENESIS,
MUTAGENESIS
AND IMPAIRMENT OF
FERTILITY;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
20-057 CEREDASE GENZYME ALGLUCERASE
28-FEB-96 (INJECTABLE) CAMBRIDGE, MA 10 UNITS/ML
02139 80 UNI
TS/ML
(LABELING REVISION --
DESCRIPTION; PRECAUTIONS)
20-272 RISPERDAL JANSSEN RISPERIDONE
28-FEB-96 (TABLET) TITUSVILLE, NJ 1MG
08560 2MG
3MG
4MG
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE)
17-831 DIDRONEL PROCTER AND GAMBLE ETIDRONATE DISODIUM
29-FEB-96 (TABLET) NORWICH, NY 200MG
13815 400MG
(LABELING REVISIO
N --
INDICATIONS AND USAGE)
50-670 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE
29-FEB-96 (CAPSULE) NEW YORK, NY EQ 250MG BASE
10017 (LABELING REVISION --
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
1200 NONE BIOMUNE SOURCE PLASMA
05-FEB-96 (INJECTABLE) BOCA RATON, FL (A,B)
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950049 CRYOCYTE FREEZING BAXTER HEALTHCARE BLOOD COMPONENT
14-FEB-96 CONTAINER IRVINE, CA FREEZING CONTAINER
92718 (C)
BK950067 THERMAL WAVE
THERMAL TRANSFER BLOOD AND PLASMA
14-FEB-96 TECHNOLOGY THERMER
PLACERVILLE, CA (C)
95667
BK950030 COBE SPECTRA COBE BCT AUTOMATED BLOOD
15-FEB-96 EXTENDED LIFE LAKEWOOD, CO CELL SEPARATOR
PLATELET SET WITH 80215 (C)
INTEGRATED
LEUKOREDUCTION
FILTER
BK950034 DOUBLE PRODUCT HAEMONETICS APHERESIS HARDWARE
15-FEB-96 COLLECTION (SDP-3) BRAINTREE, MA & DISPOSABLE
02184 COLLECTION SETS
(C)
(C) Substantially Equivalent
***BIOLOGICAL PRODUCT NDA APPROVALS***
82-0528/22 TERUFLEX TERUMO MEDICAL ANTICOAGULANT CITRATE
21-FEB-96 CPDA-1 ELKTON, MD
PHOSPHATE DEXTROSE
BLOOD BAGS 21921 ADENINE SOLUTION
(D)
88-0217/15 TERUFLEX TERUMO MEDICAL ANTICOAGULANT CITRATE
21-FEB-96 OPTISOL BLOOD ELKTON, MD PHOSPHATE DEXTROSE
COLLECTION 21921 SOLUTION WITH
SYSTEMS PRESERVATIVE
(D)
89-0105/09 HESPAN IN DUPONT MERCK 6% HETASTARCH IN
21-FEB-96 PLASTIC CONTAINER WILMINGTON, DE 0.9% SODIUM
19805 CHLORIDE INJECTIION
(D)
(D) Approved
***MEDICAL DEVICE - PREMARKET APPROVAL APPLICATIONS***
THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INF
ORMATION RESOURCES PRIOR
TO PUBLICATION
P910018 LIPOSORBER KANEKA AMERICA CORP THE DEVICE IS A LOW DENSITY
02/21/96 LA-15 SYSTEM NEW YORK, NY LIPOPROTEIN (LDL) APHERESIS
10022 SYSTEM FOR CERTAIN HIGH
RISK PATIENT POPULATIONS
P950018 PERFLUORON INFINITECH, INC. THE DEVICE IS AN
02/29/96 (PURIFIED CHESTERFIELD, MO INTRAOPERATIVE TOOL
PERFLUORO-N-OCTANE 63005 FOR USE DURING
LIQUID) VITREORETINAL SURGERY
IN PATIENTS WITH
RETINAL DETACHMENTS
***MEDICAL DEVICE - PMA SUPPLEMENTALS***
THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE D
IVISION OF DRUG INFORMATION RESOURCES PRIOR TO
PUBLICATION
N12159/S015 SURGICEL JOHNSON & JOHNSON MANUFACTURING CHANGE
02/01/96 FIBRILLAR MEDICAL, INC. WHICH ADDS A STEP TO
ABSORBABLE ARLINGTON, TX FORM A FIBRILLAR
HEMOSTAT 76004-3130 STRUCTURE FOR THE DEVICE
N17786/S025 ALLERGAN ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 HYDROCARE IRVINE, CA STERILIZATION SITE
CLEANING AND 92713-9534 AND THE USE OF 100%
DISINFECTING ETHYLENE OXIDE TO
SOLUTION STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
N18020/S041 ALLERGAN ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 HYDROCARE IRVINE, CA STERILIZATION SITE
PRESERVED SALINE 92713-9534
AND THE USE OF 100%
SOLUTION ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P790017/S049 BALLOON C.R. BARD, INC. MANUFACTURING CHANGES
02/26/96 DILATION CATHETERS BILLERICA, MA TO THE BALLOON AND
01821 INCLUDE THE USE OF A
BALLOON PROTECTOR;
NEW TRADE NAME PET ELITE
P790024/S025 LC-65 ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 DAILY CLEANER IRVINE, CA STERILIZATION SITE
92713-9534 AND THE USE OF 100%
ETHYLENE OXIDE TO
STERILIZE
PLASTIC
BOTTLES, TIPS, AND CPAS
P790025/S007 ABBOTT HBE ABBOTT LABORATORIES CHANGE IN MANUFACTURING
02/26/96 (RDNA) EIA ABBOTT PARK, IL PROCESS FOR BEAD COATING
TEST KIT 60064-3500
P800022/S048 ZYDERM I AND II COLLAGEN CORP. MANUFACTURING CHANGE
02/01/96 AND ZYPLAST PALO ALTO, CA
COLLAGEN IMPLANTS 94303
P800065/S015 LENS-WET ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 LUBRICATING IRVINE, CA STERILIZATION SITE
AND REWETTING 92713-9534 AND THE USE OF 100%
SOLUTION ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P810046/S158 ACS CONCORDE ADVANCED APPROVAL FOR ACS
02/05/96 CORONARY CARDIOVASCULAR CONCORDE CORONARY
DILATATION CATHETER SANTA CLARA, CA DILATATION CATHETER
95052-8167
P810046/S159 ACS ENDURA ADVANCED APPROVAL FOR THE ACS
02/26/96 CORONARY CARDIOVASCULAR ENDURA CORONARY
DILATATION CATHETER SANTA CLARA, CA DILATATION CATHETER
95052-8167
P840024/S055 NUCLEUS 22 COCHLEAR CORP. COMPONENT AND PROCESS
02/13/96 CHANNEL COCHLEAR ENGLEWOOD, CO CHANGES
IMPLANT 80112
P840039/S030 SINGLE-PIECE STORZ ADDITION OF D & C
02/07/96 ULTRAVIOLET- OPHTHALMICS, INC. GREEN NO. 6 DYE TO
ABSORBING POSTERIOR CLEARWATER, FL THE HAPTICS; NEW
CHAMBER INTRAOCULAR 34619 TRADE NAME B
LUE VISTA
LENSES (IOLS)
P840039/S031 ULTRAVIOLET- STORZ OPHTHALMICS, ADDITIONAL/ALTERNATIVE
02/07/96 ABSORBING POSTERIOR OPHTHALMICS, INC. VENDOR FOR
CHAMBER INTRAOCULAR CLEARWATER, FL POLYMETHYMETHACRYLATE
LENSES (IOLS) 34619 (PMMA) WITH
ULTRAVIOLET-ABSORBER
CYASORB 24 AND A NEW
FORMULATION OF THE PMMA
P840060/S022 POSTERIOR CHAMBER ALCON LABORATORIES TIER A MODELS
02/20/96 INTRAOCULAR LENSES FORT WORTH, TX
(IOLS) 76134-2099
P840066/S029 CONSEPT CLEANING ALLERGAN, INC. UNPRESERVED FORMULATION
02/29/96 AND DISINFECTING IRVINE, CA OF CONSEPT-2
SYSTEM 92713 NEUTRALIZING AND
RINSING
SOLUTION TO BE PACKAGED
IN A NON-AEROSOL CONTAINER
P850088/S034 OXYSEPT 1/ ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 ULTRACARE IRVINE, CA STERILIZATION SITE
DISINFECTING 92713-9534 AND THE USE OF 100%
SOLUTION ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P860019/S109 SCIMED SCIMED LIFE USE OF AN EPOXY ADHESIVE
02/05/96 PERCUTANEOUS SYSTEMS, INC. IN THE MANIFOLD OF THE
TRANSLUMINAL MAPLE GROVE, MN BANDIT POC BANDIT, AND
CORONARY 55311-1566 THE 15 MM NC BANDIT
ANGIOPLASTY PERCUTANEOUS TRANSLUMINAL
CATHETERS
CORONARY ANGIOPLASTY
CATHETERS
P860019/S110 SCIMED SCIMED LIFE APPROVAL FOR: 1) 10 AND
02/26/96 PERCUTANEOUS SYSTEMS, INC. 20 MM BALLOON
TRANSLUMINAL MAPLE GROVE, MN LENGTHS; 2) 2.0 AND
CORONARY 55311-1566 2.25 DIAMETER
ANGIOPLASTY BALLOONS IN THE 20 MM
CATHETERS LENGTH; AND 3) THE USE OF
AN EPOXY ADHESIVE
P870025/S004 MODEL 146 COROMETRICS MEDICAL CHANGES IN THE QUALITY
02/01/96 FETAL ACOUSTIC SYSTEMS, INC. CONTROL AND MANUFACTURING
STIMULATOR WALLINGFORD, CT PRACTICES FOR THE
06492-0333 TRANSDUCER
P870026/S007 RESOLVE/GP ALLERGAN OPTICAL ALTERNAT
E CONTRACT
02/23/96 DAILY CLEANER IRVINE, CA STERILIZATION SITE
92713-9534 AND THE USE OF 100%
ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P870037/S008 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 WETTING AND IRVINE, CA STERILIZATION SITE
SOAKING SOLUTION 92713-9534 AND THE USE OF 100%
ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P880047/S004 INTERCEED JOHNSON & JOHNSON LABELING CHANGES
02/08/96
ABSORBABLE MEDICAL, INC.
ADHESION BARRIER ARLINGTON, TX
76004-9962
P880072/S036 MODIFIED J-LOOP MEDICAL DEVELOPMENT ALTERNATE CONTRACT
02/12/96 POSTERIOR CHAMBER RESEARCH, INC. STERILIZER, MEDICAL
INTRAOCULAR ST. PETERSBURG, FL MANUFACTURING, CORP.,
LENSES (IOLS) 33716 ERIE, PA 16510, AND
CONVERSION FROM 12/88
ETHYLENE OXIDE (ETO/
FREON TO 100% ETO
STERILIZATION
P890027/S025 NUCLEUS 22 COCHLEAR CORP. COMPONENT AND PROCESS
02/13/96 CHANNEL COCHLEAR ENGLEWOOD, CO CHANGES
IMPLANT 80112
P890061/S011 VENTAK P GUIDANT
CORPORATION REPLACING THE CURRENT
02/20/96 MODEL 1600 ST. PAUL, MN CONNECTOR TOP MATERIAL
55112-5798 FOR THE ABOVE AICD
MODEL, PELLETHANE 2363-75D
POLYURETHANE, WITH
TECOTHANE TT1075D-M
POLYURETHANE
P900030/S004 CONTIGEN BARD COLLAGEN CORP. APPROVAL FOR A
02/01/96 COLLAGEN IMPLANT PALO ALTO, CA MANUFACTURING CHANGE
94303
P900039/S009 COLLAGRAFT BONE COLLAGEN CORP. APPROVAL FOR A
02/01/96 GRAFT MATRIX PALO ALTO, CA MANUFACTURING CHANGE
94303
P900047/S004 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 REWETTING DROPS SANTA ISABEL, PR STERILIZATION SITE
00757 AND USE OF 100%
ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P910075/S006 COMPLETE BRAND ALLERGAN OPTICAL ALTERNATE CONTRACT
02/23/96 MULTI-PURPOSE IRVINE, CA STERILIZATION SITE
SOLTUION 92713-9534 AND USE OF 100%
ETHYLENE OXIDE TO
STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P910077/S010 VENTAK PRX GUIDANT CORP. REPLACING THE CURRENT
02/05/96 MODEL 1705, ST. PAUL, MN CONNECTOR TOP MATERIAL
PRX II MODEL 1715, 55112-5798 FOR THE ABOVE AICD
AND PRX III
MODEL, PELLETHANE 2363-
MODELS 1720/1725 75D POLYURETHANE, WITH
TECOTHANE TT1075D-M
POLYURETHANE
P910077/S011 VENTAK PRX II/ CPI/GUIDANT, CORP. APPROVAL FOR THE USE
02/05/96 III AICD SYSTEMS ST. PAUL, MN OF MODEL 2872
55112-5798 SOFTWARE APPLICATION,
REV. 4.1 AND
MODEL 2909 MULTIPLE
APPLICATION UTILITY
(MAU) WITH THE VENTAK
PRX II/III
P920021/S001 OPUS CEA TEST BEHRING DIAGNOSTICS, APPROVAL TO ADD THE
02/23/96 SYSTEM DIAGNOSTICS, INC. CEA TEST SYSTEM TO
WESTWOOD, MA THE OPUS PLUS AND
02090 OPUS MAGNUM ANALYZERS.
THE SAME TEST SYSTEM
IS USED ON ALL THREE
INSTRUMENTS
P920047/S003 EP TECHNOLOGIES EP TECHNOLOGIES, INC. ADDITION OF
02/05/96 EPT-100 CARDIAC SUNNYVALE, CA ALTERNATIVE CATHETER
ABLATION SYSTEM 94086 CONFIGURATIONS
P930029/S006 ATAKR RFCA MEDTRONIC APPROVAL OF THE ABLATION
02/22/96 SYSTEM CARDIORHYTHM TRACKER SOFTWARE FOR USE
SAN JOSE, CA WITH THE ATAKR RF CATHETER
95134-1806 ABLATION GENERATOR SYSTEM
P930035/S004 VENTAK P2 GUIDANT CORPORATION REPLACING THE CURRENT
02/20/96 MODEL 1625 AND P3 ST. PAUL, MN CONNECTOR TOP MATERIAL
MODELS 1630/1635 55112-5798 FOR
THE ABOVE AICD
MODEL, PELLETHANE 2363-
75D POLYURETHANE, WITH
TECOTHANE TT1075D-M
POLYURETHANE
P940031/S001 VIGOR DR CARDIAC REPLACING THE CURRENT
02/20/96 PACEMAKER SYSTEM PACEMAKERS, INC. CONNECTOR TOP MATERIAL
ST. PAUL, MN FOR THE ABOVE AICD
55112 MODEL, PELLETHANE 2363-75D
POLYURETHANE, WITH
TECOTHANE TT1075D-M
POLYURETHANE
P940031/S002 VIGOR DR CARDIAC ADDING AN ALTERNATE
02/26/96 MODEL 1230 PACEMAKERS (CPI) LOWER PROFILE CONNECTOR
PACEMAKER ST. PAUL, MN TOP FOR
THE VIGOR DR
55112-5798 MODEL 1230 PACEMAKERS
***ORIGINAL VETERINARY NADAs***
200-164 NICAMIX 25 PLUS BMD CHICKENS PLANALQUIMICA IND LIDA BACITRACIN
24-FEB-96 (PREMIX) SAO PAULO, BRAZIL METHYLENE
DISALICYLATE
10GM/LB
25GM/LB
30GM/LB
40GM/LB
50GM/LB
60GM/LB
75GM/LB
NICARBAZIN
113.5GM/LB
***ORIGINAL ABBREVIATED VET
ERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR FEBRUARY 1996
***SUPPLEMENTAL VETERINARY NADAs***
THERE ARE NO SUPPLEMENTAL VETERINARY NADAs FOR FEBRUARY 1996
Date created: May 23, 1996; last updated: June 20, 2005 |
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