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Drug and Device Product Approvals for March 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-659 NORVIR ABBOTT RITONAVIR
01-MAR-96 (SOLUTION) ABBOTT PARK, IL 80MG/ML
(1 P, H*) 60064 (ANTIVIRAL)
[TREATMENT OF HIV INFECTION
IN COMBINATION WITH
NUCLEOSIDE ANALOGUES
OR AS MONOTHERAPY]
20-680 NORVIR ABBOTT RITONAVIR
01-MAR-96 (CAPSULE) ABBOTT PARK, IL 100MG
(3 P) 60064 (ANTIVIRAL)
[TREATMENT OF HIV INFECTION
IN COMBINATION WITH
NUCLEOSIDE ANALOGUES
OR AS MONOT
HERAPY]
18-735 ISOVUE-200 BRACCO DXS IOPAMIDOL
04-MAR-96 (INJECTABLE) PRINCETON, NJ 41%
(SUPPL-033) 08543 (NEW DOSAGE REGIMEN --
CONTRAST ENHANCED COMPUTED
TOMOGRAPHY (CECT) FOR HEAD
AND BODY, AT DOSES UP TO
60 GRAMS OF IODINE)
18-735 ISOVUE-250 BRACCO DXS IOPAMIDOL
04-MAR-96 (INJECTABLE) PRINCETON, NJ 51%
(SUPPL-033) 08543 (NEW DOSAGE REGIMEN --
CONTRAST ENHANCED COMPUTED
TOMOGRAPHY (CECT) FOR HEAD
AND BODY, AT DOSES UP TO
60 GRAMS OF IODINE)
H* - Accelerated Approval (drug
is intended to treat a serious or life-
threatening illness and provide a meaningful therapeutic benefit over existing
treatments, and the NDA was approved under the provisions of 21 CFR 314 Subpart
H)
18-735 ISOVUE-300 BRACCO DXS IOPAMIDOL
04-MAR-96 (INJECTABLE) PRINCETON, NJ 61%
(SUPPL-033) 08543 (NEW DOSAGE REGIMEN --
CONTRAST ENHANCED COMPUTED
TOMOGRAPHY (CECT) FOR HEAD
AND BODY, AT DOSES UP TO
60 GRAMS OF IODINE)
18-735 ISOVUE-370 BRACCO DXS IOPAMIDOL
04-MAR-96 (INJECTABLE) PRINCETON, NJ 76%
(SUPPL-033) 08543 (NEW DOSAGE REGIMEN --
CONTRAST ENHANCED COMPUTED
TOMOGRAPHY (CECT) FOR HEAD
AND BODY, AT DOSES UP TO
60 GRAMS OF IODINE)
20-569 VITRASERT CHIRON VISION GANCICLOVIR
04-MAR-96 (IMPLANT) CLAREMONT, CA 4.5-6.4MG
(3 P, V**) 91711 (ANTIVIRAL)
[TREATMENT OF CMV RETINITIS
IN PATIENTS WITH AIDS]
19-887 NEBUPENT FUJISAWA PENTAMIDINE ISETHIONATE
05-MAR-96 (INHALATION) DEERFIELD, IL 600MG/VIAL
(SUPPL-002) 60015 (NEW INDICATION --
TREATMENT OF ACUTE
PNEUMOCYSTIS CARINII
PNEUMONIA (PCP) IN HIV-
INFECTED PATIENTS)
20-254 VOLTAREN-XR GEIGY DICLOFENAC SODIUM
08
-MAR-96 (TABLET, SUMMIT, NJ 100MG
(3 S) EXTENDED RELEASE) 07901 (NONSTEROIDAL
ANTI-INFLAMMATORY)
[TREATMENT OF ACUTE
AND CHRONIC OSTEOARTHRITIS
AND RHEUMATOID ARTHRITIS]
20-685 CRIXIVAN MERCK INDINAVIR SULFATE
13-MAR-96 (CAPSULE) WEST POINT, PA EQ 200MG BASE
(1 P, H*) 19486 EQ 400MG BASE
(ANTIVIRAL)
[TREATMENT OF HIV
INFECTION IN ADULTS]
H* - Accelerated Approval (drug is intended to treat a serious or life-
threatening illness and provide a meaningful therapeutic benefit over existing
treatments, and the NDA was approved under the provisions of 21 CFR
314 Subpart
H)
V** - Designated Orphan Drug
50-605 CEFTIN GLAXO WELLCOME CEFUROXIME AXETIL
13-MAR-96 (TABLET) RES TRIANGLE PK, NC EQ 125MG BASE
(SUPPL-007) 27709 EQ 250MG BASE
EQ 500MG BASE
(NEW INDICATION --
TREATMENT OF ACUTE
BACTERIAL MAXILLARY
SINUSITIS)
50-674 VANTIN UPJOHN CEFPODOXIME PROXETIL
14-MAR-96 (TABLET) KALAMAZOO, MI EQ 100MG BASE
(SUPPL-007) 49001 EQ 200MG BASE
(NEW INDICATION --
ADDITION OF BETA-LACTAMASE-
PRODUCING STRAINS OF
HAEMOPHILUS INFLUENZAE
TO THE APPROVED
INDICATIONS FOR
COMMUNITY-ACQUIRED
PNEUMONIA AND ACUTE
BACTERIAL EXACERBATION
OF CHRONIC BRONCHITIS)
50-675 VANTIN UPJOHN CEFPODOXIME PROXETIL
14-MAR-96 (GRANULE, KALAMAZOO, MI EQ 50MG BASE/5ML
(SUPPL-009) FOR RECONSTITUTION) 49001 EQ 100MG BASE/5ML
(NEW INDICATION --
ADDITION OF BETA-LACTAMASE-
PRODUCING STRAINS OF
HAEMOPHILUS INFLUENZAE
TO THE APPROVED
INDICATIONS FOR
COMMUNITY-ACQUIRED
PNEUMONIA AND ACUTE
BACTERIAL EXACERBATION
OF CHRONIC BRONCHITIS)
20-221 ETHYOL US BIOSCIENCE AMIFOSTINE
15-MAR-96 (INJECTABLE) WEST CONSHOHOCKEN, PA 500MG/VIAL
(SUPPL-002) 19428 (NEW INDICATION --
TREATMENT OF PATIENTS
WITH NON-SMALL CELL
LUNG CANCER)
18-723 DEPAKOTE ABBOTT LABS DIVALPROEX SODIUM
18-MAR-96 (TABLET, ABBOTT PARK, IL EQ 125MG VALPROIC ACID
(SUPPL-017) DELAYED RELEASE) 60064 EQ 250MG VALPROIC ACID
EQ 500MG VALPROIC ACID
(NEW INDICATION --
PROPHYLAXIS OF MIGRAINE
HEADACHE)
20-287 FRAGMIN PHARMACIA DALTEPARIN SODIUM
18-MAR-96 (INJECTABLE) COLUMBUS, OH 2500IU/0.2ML
(SUPPL-003) 43216 5000IU/0.2ML
(NEW DOSAGE REGIMEN --
PROVIDES FOR A 5000IU
DOSE REGIMEN FOR
PROPHYLAXIS AGAINST
DEEP VENOUS THROMBOSIS)
20-261 LESCOL SANDOZ FLUVASTATIN SODIUM
20-MAR-96 (CAPSULE) EAST HANOVER, NJ EQ 20MG BASE
(SUPPL-006) 07936 EQ 40MG BASE
(NEW DOSA
GE REGIMEN --
RECOMMENDED TOTAL DAILY
DOSE TO INCLUDE 80MG
(40MG BID))
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
22-MAR-96 (CAPSULE, WAYNE, PA 10MG
(SUPPL-033) DELAYED RELEASE 19087 20MG
PELLETS) (NEW INDICATION --
TREATMENT OF ACUTE
BENIGN GASTRIC ULCER)
19-898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM
22-MAR-96 (TABLET) PRINCETON, NJ 10MG
(SUPPL-013) 08543 20MG
40MG
(NEW INDICATION --
SLOWING THE PROGRESSION
OF CORONARY
ATHEROSCLEROSIS
AND REDUCING THE RISK OF
ACUTE CORONARY EVENTS)
20-351 VISIPAQUE 270 NYCOMED IODIXANOL
22-MAR-96 (INJECTABLE) WAYNE, PA 55%
(1 S) 19087 (CONTRAST MEDIA)
20-351 VISIPAQUE 320 NYCOMED IODIXANOL
22-MAR-96 (INJECTABLE) WAYNE, PA 65.2%
(1 S) 19087 (CONTRAST MEDIA)
20-385 NICOTROL PHARMACIA NICOTINE
22-MAR-96 (SPRAY, METERED) COLUMBUS, OH 0.5MG/INH
(3 S) 43216 (SMOKING DETERRENT)
20-234 TEGRETOL-XR CIBA GEIGY CARBAMAZEPINE
25-MAR-96 (TABLET, SUMMIT, NJ 100MG
(3 S) EXTENDED RELEASE) 07901 200MG
400MG
ANTICONVULSANT)
20-548 FLOVENT GLAXO WELLCOME FLUTICASONE PROPIONATE
27-MAR-96 (AEROSOL, METERED) RES TRIANGLE PK, NC 0.11MG/INH
(3 S) 27709 0.22MG/INH
0.044MG/INH
(ASTHMA PROPHYLACTIC)
19-594 ACTIGALL CIBA URSODIOL
29-MAR-96 (CAPSULE) SUMMIT, NJ 300MG
(SUPPL-016) 07901 (NEW INDICATION --
PREVENTION OF GALLSTONES
DURING RAPID WEIGHT LOSS)
19-672 EFIDAC 24 ALZA BROMPHENIRAMINE MALEATE
29-MAR-96 PSEUDOEPHEDRINE HCL/ PALO ALTO, CA 16MG
(3 S) BROMPHENIRAMINE 94303 PSEUDOEPHEDRINE
MALEATE HYDROCHLORIDE
(T
ABLET, 240MG
EXTENDED RELEASE) (ANTIHISTAMINE/
DECONGESTANT)
(OTC)
***ERRATA***
20-144 TRANSDERM-NITRO CIBA NITROGLYCERIN
27-FEB-96* (FILM, SUMMIT, NJ 0.1MG/HR
(SUPPL-002, EXTENDED RELEASE) 07901 0.2MG/HR
003, 005, 0.4MG/HR
007, 008) 0.6MG/HR
0.8MG/HR
(VASODILATOR)
[PREVENTION OF ANGINA
PECTORIS DUE TO CORONARY
ARTERY DISEASE]
* - The approval date was omitted in February 1996 DDPA.
***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.
20-193 ELMIRON BAKER NORTON PENTOSAN POLYSULFATE SODIUM
01-MAR-96 (CAPSULE) MIAMI, FL 100MG
33178 (ANTICOAGULANT)
20-486 VANCERIL DS SCHERING BECLOMETHASONE DIPROPIONATE
06-MAR-96 (AEROSOL, METERED) KENILWORTH, NJ 0.084MG/INH
07033 (CORTICOSTEROID)
20-397 ZANAFLEX ATHENA NEUROSCIENCES TIZANIDIN
E HYDROCHLORIDE
11-MAR-96 (TABLET) S SAN FRANCISCO, CA EQ 4MG BASE
94080 (ALPHA-2 ADRENERGIC
AGONIST)
20-358 WELLBUTRIN SR GLAXO WELLCOME BUPROPION HYDROCHLORIDE
12-MAR-96 (TABLET, RES TRIANGLE PK, NC 50MG
SUSTAINED RELEASE) 27709 100MG
150MG
(ANTIDEPRESSANT)
20-310 NIZORAL A-D J AND J KETOCONAZOLE
13-MAR-96 (SHAMPOO) SKILLMAN, NJ 1%
08558 (ANTIFUNGAL)
(OTC)
20-559 TRITEC GLAXO WELLCOME RANITIDINE BISMUTH CITRATE
29-MAR-96 (TABLET) RES TRIANGLE PK, NC 400MG
27709
(HISTAMINE H2-RECEPTOR
ANTAGONIST/CYTOPROTECTANT)
***ORIGINAL ABBREVIATED NDAs***
72-922 VERAPAMIL HCL SIDMAK LABS NJ VERAPAMIL HYDROCHLORIDE
01-MAR-96 (TABLET, EAST HANOVER, NJ 240MG
EXTENDED RELEASE) 07936 (CALCIUM ION
INFLUX INHIBITOR)
40-122 HYDROCODONE ROYCE LABS ACETAMINOPHEN
04-MAR-96 BITARTRATE AND MIAMI, FL 500MG
ACETAMINOPHEN 33014 HYDROCODONE BITARTRATE
(TABLET) 5MG
(ANALGESIC)
40-122 HYDROCODONE ROYCE LABS ACETAMINOPHEN
04-MAR-96 BITARTRATE AND MIAMI, FL 750MG
ACETAMINOPHEN 33014 HYDROCODONE BITARTRAT
E
(TABLET) 7.5MG
(ANALGESIC)
40-123 HYDROCODONE ROYCE LABS ACETAMINOPHEN
04-MAR-96 BITARTRATE AND MIAMI, FL 500MG
ACETAMINOPHEN 33014 HYDROCODONE BITARTRATE
(TABLET) 2.5MG
(ANALGESIC)
40-123 HYDROCODONE ROYCE LABS ACETAMINOPHEN
04-MAR-96 BITARTRATE AND MIAMI, FL 500MG
ACETAMINOPHEN 33014 HYDROCODONE BITARTRATE
(TABLET) 7.5MG
(ANALGESIC)
40-123 HYDROCODONE ROYCE LABS ACETAMINOPHEN
04-MAR-96 BITARTRATE AND MIAMI, FL 650MG
ACETAMINOPHEN 33014 HYDROCODONE BITARTRATE
(TABLET) 7.5MG
(ANALGESIC)
40-123 HYDROCODONE ROYCE LABS ACETAMINOPHEN
04-MAR-96 BITARTRATE AND MIAMI, FL 650MG
ACETAMINOPHEN 33014 HYDROCODONE BITARTRATE
(TABLET) 10MG
(ANALGESIC)
74-387 GLIPIZIDE NOVOPHARM LTD GLIPIZIDE
04-MAR-96 (TABLET) SCARBOROUGH, ONTANIO 5MG
CANADA 10MG
(BLOOD GLUCOSE REGULATOR)
40-114 ESTRADIOL WATSON LABS ESTRADIOL
14-MAR-96 (TABLET) CORONA, CA 0.5MG
91720 1MG
2MG
(ESTROGENS)
74-513 ETOPOSIDE LEDERLE LABS ETOPOSIDE
14-MAR-96 (INJECTABLE) PEARL RIVER, NY 20MG/ML
10965
(ANTINEOPLASTIC)
40-043* EDROPHONIUM CHLORIDE STERIS EDROPHONIUM CHLORIDE
20-MAR-96 PRESERVATIVE FREE PHOENIX, AZ 10MG/ML
(INJECTABLE) 85043 (NONDEPOLARIZING
NEUROMUSCULAR RELAXANT
ANTAGONIST)
40-044 EDROPHONIUM CHLORIDE STERIS EDROPHONIUM CHLORIDE
20-MAR-96 (INJECTABLE) PHOENIX, AZ 10MG/ML
85043 (NONDEPOLARIZING
NEUROMUSCULAR RELAXANT
ANTAGONIST)
74-524 KETAMINE HCL BEDFORD KETAMINE HYDROCHLORIDE
22-MAR-96 (INJECTABLE) BEDFORD, OH EQ 50MG BASE/ML
44146 EQ 100MG BASE/ML
(ANESTHETIC, GENERAL)
74-587 VERAPAMIL HCL MYLAN VERAPAMIL HYDROCHLORIDE
2
3-MAR-96 (TABLET, MORGANTOWN, WV 240MG
EXTENDED RELEASE) 26504 (CALCIUM ION INFLUX
INHIBITOR)
74-514 DICLOFENAC SODIUM PUREPAC PHARM DICLOFENAC SODIUM
26-MAR-96 (TABLET, ELIZABETH, NJ 50MG
DELAYED RELEASE) 07207 75MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-461 INDAPAMIDE MYLAN INDAPAMIDE
27-MAR-96 (TABLET) MORGANTOWN, WV 2.5MG
26504 (ANTIHYPERTENSIVE/
DIURETIC)
40-085* ESGIC-PLUS MIKART ACETAMINOPHEN
28-MAR-96 (CAPSULE) ATLANTA, GA 500MG
30318 BUTALBITAL
50MG
CAFFEI
NE
40MG
(ANALGESIC)
* - First Time Product Available Generically
74-399 TOLMETIN SODIUM BAKER NORTON TOLMETIN SODIUM
28-MAR-96 (TABLET) MIAMI, FL EQ 600MG BASE
33178 (NONSTEROIDAL
ANTI-INFLAMMATORY)
70-848* SUCRALFATE BIOCRAFT SUCRALFATE
29-MAR-96 (TABLET) FAIR LAWN, NJ 1GM
07410 (ANTIULCER)
74-164 MICONAZOLE 7 NMC MICONAZOLE NITRATE
29-MAR-96 (CREAM) BALTIMORE, MD 2%
21224 (ANTIFUNGAL)
(OTC)
74-364* CLOMIPRAMINE HCL GENEVA PHARMS CLOMIPRAMINE HYDROCHLORIDE
29-MAR-96 (CAPSULE) BROOMFIELD, CO 25MG
80038 50MG
75MG
(ANTIDEPRESSANT)
74-520* OXYBUTYNIN CHLORIDE SILARX OXYBUTYNIN CHLORIDE
29-MAR-96 (SYRUP) SPRING VALLEY, NY 5MG/5ML
10977 (ANTISPASMODIC)
***ERRATA***
40-024** DEXFERRUM LUITPOLD IRON DEXTRAN
23-FEB-96 (INJECTABLE) SHIRLEY, NY EQ 50MG IRON/ML
11967 (MINERAL REPLACEMENT)
* - First Time Product Available Generically
** - Not specified as a 505(b)2 application in February 1996 DDPA
***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.
74-488 RANITIDINE HCL GRANUTEC RANITIDINE HYDROCHLORIDE
05-MAR-96 (TABLET) WILSON, NC EQ 150MG BASE
27896 EQ 300MG BASE
(HISTAMINE H-2
RECEPTOR ANTAGONIST)
***LABELING SUPPLEMENTS TO ORIGINAL
NDAs***
04-570 HEPARIN SODIUM UPJOHN HEPARIN SODIUM
04-MAR-96 (INJECTABLE) KALAMAZOO, MI 1,000 UNITS/ML
49001 5,000 UNITS/ML
10,000 UNITS/ML
(LABELING REVISION --
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-735 ISOVUE-200 BRACCO DXS IOPAMIDOL
04-MAR-96 (INJECTABLE) PRINCETON, NJ 41%
08543 (LABELING REVISION --
DESCRIPTION;
WARNINGS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-735 ISOVUE-250 BRACCO DXS IOPAMIDOL
04-MAR-96 (INJECTABLE) PRINCETON, NJ 51%
08543 (LABELING REVISION --
DESCRIPTION;
WARNINGS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-735 ISOVUE-300 BRACCO DXS IOPAMIDOL
04-MAR-96 (INJECTABLE) PRINCETON, NJ 61%
08543 (LABELING REVISION --
DESCRIPTION;
WARNINGS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-735 ISOVUE-370 BRACCO DXS IOPAMIDOL
04-MAR-96 (INJECTABLE) PRINCETON, NJ 76%
08543 (LABELING REVISION --
DESCRIPTION;
WARNINGS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
50-564 AUGMENTIN '250' SMITHKLINE BEECHAM AMOXICILLIN
04-MAR-96 (TABLET) PHILADELPHIA, PA 250MG
19101 CLAVULANATE POTASSIUM
EQ 125MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
50-564 AUGMENTIN '500' SMITHKLINE BEECHAM AMOXICILLIN
04-MAR-96 (TABLET) PHILADELPHIA, PA 500MG
19101 CLAVULANATE POTASSIUM
EQ 125MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
50-575 AUGMENTIN '125' SMITHKLINE BEECHAM AMOXICILLIN
04-MAR-96 (POWDER PHILADELPHIA, PA 125MG/5ML
FOR RECONSTITUTION) 19101 CLAVULANATE POTASSIUM
EQ 31.25MG BASE/5ML
(LABELING REVISION --
ADVERSE REACTIONS)
50-575 AUGMENTIN '250' SMITHKLINE BEECHAM AMOXICILLIN
04-MAR-96 (POWDER PHILADELPHIA
, PA 250MG/5ML
FOR RECONSTITUTION) 19101 CLAVULANATE POTASSIUM
EQ 62.5MG BASE/5ML
(LABELING REVISION --
ADVERSE REACTIONS)
50-597 AUGMENTIN '125' SKB PHARMS AMOXICILLIN
04-MAR-96 (TABLET, CHEWABLE) KING OF PRUSSIA, PA 125MG
19406 CLAVULANATE POTASSIUM
EQ 31.25MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
50-597 AUGMENTIN '250' SKB PHARMS AMOXICILLIN
04-MAR-96 (TABLET, CHEWABLE) KING OF PRUSSIA, PA 250MG
19406 CLAVULANATE POTASSIUM
EQ 62.5MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
19-887 NEBUPENT FUJISAWA USA PENTAMIDINE ISETHIONATE
05-MAR-96 (POWDER DEERFIELD, IL 600MG/VIAL
FOR RECONSTITUTION) 60015 (LABELING REVISION --
INDICATIONS AND USAGE)
50-441 CLEOCIN PHOSPHATE UPJOHN CLINDAMYCIN PHOSPHATE
05-MAR-96 (INJECTABLE) KALAMAZOO, MI EQ 150MG BASE/ML
49001 (LABELING REVISION --
PRECAUTIONS)
16-363 LASIX HOECHST ROUSSEL FUROSEMIDE
06-MAR-96 (INJECTABLE) SOMERVILLE, NJ 10MG/ML
08876 (LABELING REVISION --
INDICA
TIONS AND USAGE;
WARNINGS;
DOSAGE AND ADMINISTRATION)
17-377 BACTRIM ROCHE SULFAMETHOXAZOLE
06-MAR-96 (TABLET) NUTLEY, NJ 400MG
07110 TRIMETHOPRIM
80MG
(LABELING REVISION --
PRECAUTIONS)
17-377 BACTRIM DS ROCHE SULFAMETHOXAZOLE
06-MAR-96 (TABLET) NUTLEY, NJ 800MG
07110 TRIMETHOPRIM
160MG
(LABELING REVISION --
PRECAUTIONS)
17-560* BACTRIM ROCHE SULFAMETHOXAZOLE
06-MAR-96 (SUSPENSION) NUTLEY, NJ
200MG/5ML
07110 TRIMETHOPRIM
40MG/5ML
(LABELING REVISION --
PRECAUTIONS)
17-560 BACTRIM PEDIATRIC ROCHE SULFAMETHOXAZOLE
06-MAR-96 (SUSPENSION) NUTLEY, NJ 200MG/5ML
07110 TRIMETHOPRIM
40MG/5ML
(LABELING REVISION --
PRECAUTIONS)
17-820 DOBUTREX ELI LILLY DOBUTAMINE HYDROCHLORIDE
06-MAR-96 (INJECTABLE) INDIANAPOLIS, IN EQ 12.5MG BASE/ML
46285 (LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
OVERDOSAGE; HOW SUPPLIED)
18-374 BACTRIM ROCHE SULFAMETHOXAZOLE
06-MAR-96 (INJECTABLE) NUTLEY, NJ 80MG/ML
07110 TRIMETHOPRIM
16MG/ML
(LABELING REVISION --
PRECAUTIONS)
* - Not Marketed At This Time
20-225 IMDUR SCHERING ISOSORBIDE MONONITRATE
06-MAR-96 (TABLET, KENILWORTH, NJ 30MG
EXTENDED RELEASE) 07033 60MG
120MG
(LABELING REVISION --
DESCRIPTION;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
50-521 CECLOR ELI LILLY CEFACLOR
06-MAR-96 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE
46285 EQ 500MG BASE
(LABELING REVISION --
PRECAUTIONS)
50-522 CECLOR ELI LILLY CEFACLOR
06-MAR-96 (POWDER INDIANAPOLIS, IN EQ 125MG BASE/5ML
FOR RECONSTITUTION) 46285 EQ 250MG BASE/5ML
(LABELING REVISION --
PRECAUTIONS)
50-341* FUNGIZONE BRISTOL MYERS SQUIBB AMPHOTERICIN B
07-MAR-96 (SUSPENSION) PRINCETON, NJ 100MG/ML
08543 (LABELING REVISION --
DES
CRIPTION;
MICROBIOLOGY;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
17-354 LOESTRIN FE 1/20 PARKE DAVIS ETHINYL ESTRADIOL
08-MAR-96 (TABLET) MORRIS PLAINS, NJ 0.02MG
07950 FERROUS FUMARATE
75MG
NORETHINDRONE ACETATE
1MG
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
DETAILED PPI;
BRIEF SUMMARY PPI)
* - Not Marketed At This Time
17-355 LOESTRIN FE 1.5/30 PARKE DAVIS ETHINYL ESTRADIOL
MORRIS PLAINS, NJ 0.03MG
07950 FERROUS FUMARATE
75MG
NORETHINDRONE ACETATE
1.5MG
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRAT
ION;
DETAILED PPI;
BRIEF SUMMARY PPI)
17-875 LOESTRIN 21 1.5/30 PARKE DAVIS ETHINYL ESTRADIOL
08-MAR-96 (TABLET) MORRIS PLAINS, NJ 0.03MG
07950 NORETHINDRONE ACETATE
1.5MG
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
DETAILED PPI;
BRIEF SUMMARY PPI)
17-876 LOESTRIN 21 1/20 PARKE DAVIS ETHINYL ESTRADIOL
08-MAR-96 (TABLET) MORRIS PLAINS, NJ 0.02MG
07950 NORETHINDRONE ACETATE
1MG
(LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
DETAILED PPI;
BRIEF SUMMARY PPI)
20-171 DELFLEX FRESENIUS CALCIUM CHLORIDE
08-MAR-96 W/DEXTROSE 1.5% WALNUT CREEK, CA 18.4MG/100ML
LOW MAGNESIUM 94598 DEXTROSE
LOW CALCIUM 1.5GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(SOLUTION) 5.08MG/100ML
SODIUM CHLORIDE
538MG/100ML
SODIUM LACTATE
448MG/100ML
(LA
BELING REVISION --
DESCRIPTION;
WARNINGS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
20-171 DELFLEX FRESENIUS CALCIUM CHLORIDE
08-MAR-96 W/DEXTROSE 2.5% WALNUT CREEK, CA 18.4MG/100ML
LOW MAGNESIUM 94598 DEXTROSE
LOW CALCIUM 2.5GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(SOLUTION) 5.08MG/100ML
SODIUM CHLORIDE
538MG/100ML
SODIUM LACTATE
448MG/100ML
(LABELING REVISION --
DESCRIPTION;
WARNINGS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
20-171 DELFLEX FRESENIUS CALCIUM CHLORIDE
08-MAR-96 W/DEXTROSE 4.25% WALNUT CREEK, CA 18.4MG/100ML
LOW MAGNESIUM 94598 DEXTROSE
LOW CALCIUM 4.25GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(SOLUTION) 508MG/100ML
SODIUM CHLORIDE
538MG/100ML
SODIUM LACTATE
448MG/100ML
(LABELING REVISION --
DESCRIPTION;
WARNINGS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
50-718 DOXIL SEQUUS PHARM DOXORUBICIN HYDROCHLORIDE
08-MAR-96 (INJECTABLE) MENLO PARK, CA 2MG/ML
94025 (LABELING REVISION --
DOSAGE AND ADMINISTRATION)
20-049 PENTASA HOECHST MARION RSSL MESALAMINE
11-MAR-96 (CAPSULE, KANSAS CITY, MO 250MG
EXTENDED RELEASE) 64134 (LABELING REVISION --
ADVERSE REACTIONS)
18-584 BECONASE GLAXO WELLCOME BECLOMETHASONE
12-MAR-96 (AEROSOL, METERED) RES TRIANGLE PK, NC DIPROPIONATE
27709 0.042MG/INH
(LABELING REVISION --
W
ARNINGS)
19-962 TOPROL-XL ASTRA USA METOPROLOL SUCCINATE
12-MAR-96 (TABLET, WESTBOROUGH, MA EQ 50MG METOPROLOL
EXTENDED RELEASE) 01581 TARTRATE
EQ 100MG METOPROLOL
TARTRATE
EQ 200MG METOPROLOL
TARTRATE
(LABELING REVISION --
DESCRIPTION)
20-007 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE
12-MAR-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 2MG BASE/ML
27709 (LABELING REVISION --
PRECAUTIONS)
20-403 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE
12-MAR-96 IN PLASTIC CONTAINER RES TRIANGLE PK, NC EQ 0.64MG BA
SE/ML
(INJECTABLE) 27709 (LABELING REVISION --
PRECAUTIONS)
19-790 DILATRATE-SR SPKU ISOSORBIDE DINITRATE
13-MAR-96 (CAPSULE, MILWAUKEE, WI 40MG
EXTENDED RELEASE) 53201 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
50-605 CEFTIN GLAXO WELLCOME CEFUROXIME AXETIL
13-MAR-96 (TABLET) RES TRIANGLE PK, NC EQ 125MG BASE
27709 EQ 250MG BASE
EQ 500MG BASE
(LABELING REVISION --
INDICATIONS AND USAGE;
CLINICAL STUDIES)
16-954 MICRONOR JOHNSON RW NORETHINDRONE
14-MAR-96 (TABLET) RARITAN, NJ 0.35MG
08869 (LABELING REVISION --
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
PATIENT PACKAGE INSERT)
50-674 VANTIN UPJOHN CEFPODOXIME PROXETIL
14-MAR-96 (TABLET) KALAMAZOO, MI EQ 100MG BASE
49001 EQ 200MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
50-674 VANTIN UPJOHN CEFPODOXIME PROXETIL
14-MAR-96 (TABLET) KALAMAZOO, MI EQ 100MG BASE
49001 EQ 200MG BASE
(LABELING REVISION --
INDICATIONS AND USAGE)
50-675 VANTIN UPJOHN CEFPODOXIME PROXETIL
14-MAR-96 (GRANULE, KALAMAZOO, MI EQ 50MG BASE/5ML
FOR RECONSTITUTION) 49001 EQ 100MG BASE/5ML
(LABELING REVISION --
ADVERSE REACTIONS)
50-675 VANTIN UPJOHN CEFPODOXIME PROXETIL
14-MAR-96 (GRANULE, KALAMAZOO, MI EQ 50MG BASE/5ML
FOR RECONSTITUTION) 49001 EQ 100MG BASE/5ML
(LABELING REVISION --
INDICATIONS AND USAGE)
20-221 ETHYOL US BIOSCIENCE AMIFOSTINE
15-MAR-96 (INJECTABLE) WEST CONSHOHOCKEN, PA 500MG/VIAL
19428 (LABELING REVISION --
INDICATIONS AND USAGE)
18-723 DEPAKOTE ABBOTT LABS DIVALPROEX SODIUM
18-MAR-96 (TABLET, ABBOTT PARK, IL EQ 125MG VALPROIC ACID
DELAYED RELEASE) 60064 EQ 250MG VALPROIC ACID
EQ 500MG VALPROIC ACID
(LABELING REVISION --
INDICATIONS AND USAGE)
20-287 FRAGMIN PHARMACIA DALTEPARIN SODIUM
18-MAR-96 (INJECTABLE) COLUMBUS, OH 2500IU/0.2ML
43216 5000IU/0.2ML
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
ADVERSE RE
ACTIONS;
DOSAGE AND ADMINISTRATION)
20-287 FRAGMIN PHARMACIA DALTEPARIN SODIUM
18-MAR-96 (INJECTABLE) COLUMBUS, OH 2500IU/0.2ML
43216 5000IU/0.2ML
(LABELING REVISION --
HOW SUPPLIED)
20-444 FLOLAN GLAXO WELLCOME EPOPROSTENOL SODIUM
18-MAR-96 (INJECTABLE) RES TRIANGLE PK, NC EQ 0.5MG BASE/VIAL
27709 EQ 1.5MG BASE/VIAL
(LABELING REVISION --
DOSAGE AND ADMINISTRATION)
18-140 ATIVAN WYETH AYERST LABS LORAZEPAM
19-MAR-96 (INJECTABLE) PHILADELPHIA, PA 2MG/ML
19101 4MG/ML
(LABELING RE
VISION --
OVERDOSAGE;
DIRECTIONS FOR USE)
20-243 LUVOX SOLVAY FLUVOXAMINE MALEATE
19-MAR-96 (TABLET) MARIETTA, GA 50MG
30062 100MG
(LABELING REVISION --
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS)
19-058 TENORMIN ZENECA PHARMS ATENOLOL
20-MAR-96 (INJECTABLE) WILMINGTON, DE 0.5MG/ML
19850 (LABELING REVISION --
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS)
20-246 DEPO-PROVERA UPJOHN MEDROXYPROGESTERONE ACETATE
20-MAR-96 (INJECTABLE) KALAMAZOO, MI 150MG/ML
49001 (LABELING REVISION --
WARNINGS;
DOSAGE AND ADMINISTRATION)
20-261 LESCOL SANDOZ FLUVASTATIN SODIUM
20-MAR-96 (CAPSULE) EAST HANOVER, NJ EQ 20MG BASE
07936 EQ 40MG BASE
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
18-482 PROCARDIA PFIZER NIFEDIPINE
22-MAR-96 (CAPSULE) NEW YORK, NY 10MG
10017 20MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS)
19-478 ADALAT BAYER NIFEDIPINE
22-MAR-96 (CAPSULE) WEST HAVEN, CT 10MG
06516 20MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS)
19-487 IMODIUM A-D MCNEIL CONSUMER LOPERAMIDE HYDROCHLORIDE
22-MAR-96 (SOLUTION) FORT WASHINGTON, PA 1MG/5ML
19034 (LABELING REVISION --
CONTAINER LABEL;
CARTON LABEL;
PATIENT PACKAGE PAMPHLET)
(OTC)
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
22-MAR-96 (CAPSULE, WAYNE, PA 10MG
DELAYED
RELEASE 19087 20MG
PELLETS) (LABELING REVISION --
INDICATIONS AND USAGE)
19-887 NEBUPENT FUJISAWA USA PENTAMIDINE ISETHIONATE
22-MAR-96 (POWDER DEERFIELD, IL 600MG/VIAL
FOR RECONSTITUTION) 60015 (LABELING REVISION --
DESCRIPTION;
HOW SUPPLIED)
19-898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM
22-MAR-96 (TABLET) PRINCETON, NJ 10MG
08543 20MG
40MG
(CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE)
17-970 NOLVADEX ZENECA PHARMS
TAMOXIFEN CITRATE
26-MAR-96 (TABLET) WILMINGTON, DE EQ 10MG BASE
19850 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
WARNINGS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-264 PENTAM FUJISAWA PENTAMIDINE ISETHIONATE
29-MAR-96 (INJECTABLE) DEERFIELD, IL 300MG/VIAL
60015 (LABELING REVISION --
DESCRIPTION;
WARNINGS; HOW SUPPLIED)
19-462 PEPCID MERCK FAMOTIDINE
29-MAR-96 (TABLET) WEST POINT, PA 20MG
19486 40MG
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-527 PEPCID MERCK FAMOTIDINE
29-MAR-96 (POWDER WEST POINT, PA 40MG/5ML
FOR RECONSTITUTION) 19486 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-594 ACTIGALL CIBA URSODIOL
29-MAR-96 (CAPSULE) SUMMIT, NJ 300MG
07901 (LABELING REVISION --
INDICATIONS AND USAGE)
19-887 NEBUPENT FUJISAWA USA PENTAMIDINE ISETHIONATE
29-MAR-96 (POWDER DEERFIELD, IL 30
0MG/VIAL
FOR RECONSTITUTION) 60015 (LABELING REVISION --
DESCRIPTION;
PRECAUTIONS;
ADVERSE REACTIONS;
HOW SUPPLIED)
20-198 ADALAT CC BAYER NIFEDIPINE
29-MAR-96 (TABLET, WEST HAVEN, CT 30MG
EXTENDED RELEASE) 06516 60MG
(LABELING REVISION --
HOW SUPPLIED)
20-238 TAGAMET HB SMITHKLINE BEECHAM CIMETIDINE
29-MAR-96 (TABLET) PARSIPPANY, NJ 100MG
07054 (LABELING REVISION --
CARTON LABELING USES)
(OTC)
20-355 STIMATE ARMOUR PHARM DESMOPRESSIN
ACETATE
29-MAR-96 (SPRAY, METERED) COLLEGEVILLE, PA 0.15MG/INH
19426 (LABELING REVISION --
PRECAUTIONS)
50-444 MINOCIN LEDERLE LABS MINOCYCLINE HYDROCHLORIDE
29-MAR-96 (INJECTABLE) PHILADELPHIA, PA EQ 100MG BASE/VIAL
19101 (LABELING REVISION --
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
0248 NONE SOUTH BEND RED BLOOD CELLS
05-MAR-96 (INJECTABLE) MED FOUNDATION (B)
SOUTH BEND, IN
46601
0695 NONE COMM BLOOD BANK OF PLASMA
05-MAR-96 (INJECTABLE) LANCASTER CNTY MED (B)
SOCIETY
LINCOLN, NE
68510
1185 NONE COULTER HIV-1 p24 ANTIGEN ELISA
14-MAR-96 (IN VITRO) MIAMI, FL TEST SYSTEM
33116 (A,B)
0197 NONE BLOOD BANK OF PLASMA
15-MAR-96 (INJECTABLE) REDWOODS (B)
SANTA ROSA, CA
95405
0002 NONE MERCK HEPATITIS A VACCINE
29-MAR-96 (INJECTABLE) WEST POINT, PA (B)
19486
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
THERE ARE NO BIOLOGICAL PRODUCT DEVICE APPROVALS FOR MARCH 1996.
***BIOLOGICAL PRODUCT NDA APPROVALS***
THERE ARE NO BIOLOGICAL PRODUCT NDA APPROVALS FOR MARCH 1996.
***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
P890055 MODEL 3000 ARROW INDICATED FOR THE
03/11/96 CONSTANT FLOW INTERNATIONAL CONTINUOUS REGIONAL
IMPLANTABLE PUMP WALPOLE, MA INTRA-ARTERIAL DELIVERY
WITH BOLUS SAFETY 02081 OF 2'-DEOXY-5-
VALVE FLUOROURIDINE (FUDER,
HEPARINIZED SALINE,
NORMAL SALINE, AND
BACTERIOSTATIC WATER
P900033 INTEGRA INTEGRA INDICATED FOR THE POST-
03/01/96 (ARTIFICIAL SKIN) LIFESCIENCES CORP. EXCISIONAL TREATMENT OF
PLAINSBORO, NJ
LIFE-THREATENING FULL-
08536 THICKNESS OR DEEP
PARTIAL-THICKNESS THERMAL
INJURY WHERE SUFFICIENT
AUTOGRAFT IS NOT AVAILABLE
P930016 VISX EXCIMER VISX, INC. INDICATED FOR A 6.0 MM
03/27/96 LASER SYSTEM SANTA CLARA, CA ABLATION ZONE, MYOPIC
MODELS "B" AND "C" 95051 PHOTOREFRACTIVE
KERATECTOMY (PRK) IN
PATIENTS WHO MEET SPECIFIC
CRITERIA
P930039 CAPSUREFIX MEDTRONIC, INC. INDICATED TO BE USED WITH
03/29/96 PACING LEAD, MINNEAPOLIS, MN A PULSE GENERATOR AS PART
MODEL 4068 55432-3576 OF A CARDIAC PACING SYSTEM
P940022 CLARION ADVANCED BIONICS CORP. INDICATED TO RESTORE A
03/22/96 MULTI-STRATEGY SYLMAR, CA LEVEL OF AUDITORY
COCHLEAR IMPLANT 91342 SENSATION TO
INDIVIDUALS
WITH PROFOUND
SENSORINEURAL DEAFNESS
VIA ELECTRICAL
STIMULATION
OF THE AUDITORY NERVE
P950011 TRUQUANT BIOMIRA AN IN VITRO DIAGNOSTIC
03/29/96 BR RIA DIAGNOSTICS, INC. DEVICE FOR THE
ROCKVILLE, MD QUANTITATIVE DETERMINATION
20855 OF CA 27.29 ANTIGEN IN
SERUM OR EDTA PLASMA OF
PATIENTS PREVIOUSLY TREATED
FOR STAGE II OR III BREAST
CANCER
***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
N18033/S028 MOLDED VISTAKON, JOHNSON UTILIZATION OF AN
03/05/96 ETAFILCON A AND JOHNSON, INC. ALTERNATE PROTOCOL
SOFT (HYDROPHILIC) JACKSONVILLE, FL FOR ESTABLISHING
CONTACT LENSES 32247 SHELF-LIFE STABILITY
(CLEAR AND WITH
VISIBILITY TINT)
P810002/S038 ST. JUDE MEDICAL ST. JUDE MEDICAL, INC. EXTENSION OF THE SHELF
03/13/96 MECHANICAL HEART ST. PAUL, MN
LIFE OF THE MECHANICAL
VALVE 55117 HEART VALVE (ALL
CURRENTLY
APPROVED MODELS) AND
THE COATED AORTIC
VALVED
GRAFT (CAVG),
MODEL CAVG-404
P810002/S039 ST. JUDE MEDICAL ST. JUDE MEDICAL, INC. EXPANDED VERSION OF
03/21/96 MECHANICAL HEART ST. PAUL, MN THE DEVICE WITH
VALVE (EXPANDED 55117 TEFLON SEWING CUFF
(SEWING CUFF)
P820003/S071 VERSATRAX MEDTRONIC, INC. ALTERNATE
03/13/96 PULSE GENERATOR MINNEAPOLIS, MN STERILIZATION
SYSTEM ENHANCEMENT 55432-3576 PROCESS
MODULE
P820021/S028 FOCUS AND NEWVUES CIBA VISION, CORP. AUTOMATED
03/18/96 (VILFILCON A) DULUTH, GA MANUFACTURING LINE
SOFT (HYDROPHILIC) 30136-1518 AND PROCESS
CONTACT LENSES
P820049/S063 POSTERIOR CHAMBER ALLERGAN MEDICAL ADDITION OF THE
03/11/96 PMMA INTRAOCULAR OPTICS STERILIZATION
LENSES (IOLS) IRVINE, CA SERVICES OF TENNESSEE
92713-9534 (SST) AS AN ALTERNATE
100% ETO
STERILIZATION SITE FOR
IOLS
P830026/S066 COSMOS II INTERMEDICS, INC. INTRODUCTION OF
03/22/96 PACING SYSTEM ANGLETON, TX LABELING ADDRESSING
77515 COMPATIBILITY OF
PACEMAKERS WITH
CELLULAR TELEPHONES
P840019/S012 TANDEM-R CEA HYBRITECH, INC. ENHANCEMENTS IN THE
03/07/96 IMMUNORADIOMETRIC SAN DIEGO, CA FORMULATION OF THE
ASSAY 92196 ALKALINE PHOSPHATASE-
LABELED ANTI-CEA
CONJUGATE AND THE
ADDITION OF THE BLOCKING
REAGENT POLY MAK 33 NEW
TRADE NAME:TANDEM-E CEA
P840024/S060 NUCLEUS 22 COCHLEAR, CORP. COMPONENT REVISIONS,
03/26/96 CHANNEL COCHLEAR ENGLEWOOD, CO LABELING, AND
IMPLANT SYSTEM 80112 MANUFACTURING CHANGES
P840064/S015 VISCOAT ALCON LABORATORIES ALTERNATE MANUFACTURING
03/22/96 VISCOELASTIC FORT WORTH, TX SITE; 100% ETHYLENE OXIDE
MATERIAL 76134-2099 STERILIZATION PROCESS;
AND INCREASE IN THE
ALLOWABLE
FILL VOLUME TO 0.75 ML
P840064/S016 DUOVISC ALCON LABORATORIES ALTERNATE MANUFACTURING
03/26/96 VISCOELASTIC FORT WORTH, TX SITE (PUURS, BELGIUM)
SYSTEM 76134-2099 AND A SINGLE BLISTER
PACKAGE CONTAINING BOTH
PROVISC AND VISCOAT
WITH DELIVERY CANNULAS
(24 MONTHS EXP.)
P840068/S027 VIGOR DDD CARDIAC ADDITION OF AN ALTERNATE
03/12/96 MODEL 950 PACEMAKERS (CPI) LOWER PROFILE CONNECTOR
PACEMAKER ST. PAUL, MN TOP
55112-5798
P840068/S028 VIGOR MODEL 2880 GUIDANT CORP. DEVICE USED IN CONJUNCTION
03/22/96 SOFTWARE ST. PAUL, MN WITH THE MODEL 2909
APPLICATION 55112-5798 MULTIPLE APPLICATION
UTILITY (MAU)
ON MODEL 2950 PRM FOR
PROGRAMMING OF ALL
COMMERCIALLY AVAILABLE
VIGOR PACEMAKERS
P850051/S052 ACTIVITRAX MEDTRONIC, INC. ALTERNATE STERILIZATION
03/13/96 PULSE GENERATOR MINNEAPOLIS, MN PROCESS
SYSTEM PACEMAKERS 55432
P860007/S017 INTERTACH INTERMEDICS, INC. INTRODUCTION OF
03/22/96 PACING SYSTEM ANGELTON, TX LABELING ADDRESSING
77515 COMPATIBILITY OF
PACEMAKERS WITH CELLULAR
TELEPHONES
P860034/S014 ANTERIOR CHAMBER ALLERGAN MEDICAL ADDITION OF STERILIZATION
03/11/96 PMMA IOLS
OPTICS SERVICES OF TENNESSEE (SST)
IRVINE, CA AS AN ALTERNATE 100% ETO
92713-9534 STERILIZATION SITE
P870018/S011 LITHOSTAR SHOCK SIEMENS MEDICAL MODIFICATIONS MADE TO
03/01/96 WAVE SYSTEM C SYSTEMS, INC. THE SHOCK TUBE, WATER
ISELIN, NJ CONDITIONING SYSTEM,
08830 SHOCK WAVE GENERATOR,
SHOCK WAVE ENERGY
SETTING, AND LABELING
P870018/S013 LITHOSTAR SIEMENS MEDICAL MODIFICATIONS MADE TO
03/13/96 LITHOTRIPTER SYSTEMS, INC. THE ZOOM FUNCTION AND
ISELIN, NJ LABELING; NEW TRADE
08830 NAME:LITHOSTAR
P870049/S024 MICROSCAN RAPID DADE OFLOXACIN TO BE ADDED
03/12/96 FLUOROGENIC INTERNATIONAL TO THE GRAM-NEGATIVE
PANELS WEST SACRAMENTO, CA RAPID FLUOROGENIC
95691 PANELS AT THE EQUIVALENCY
CONCENTRATIONS OF
0.25 TO 16 UG/ML
P870076/S003 FALOPE-RING CABOT MEDICAL CORP. CHANGE STERILIZATION
03/01/96 BAND AND LANGHORNE, PA FACILITY TO THE
APPLICATOR 19047 MEDICAL MANUFACTURING
SYSTEM CORP. ERIE, PA
P880003/S052 CORDIS PTCA CORDIS CORP. NEW MODELS:TITAN AND
03/13/96 DILATATION
MIAMI, FL TITAN XL 3.25 AND
CATHETER 33102-5700 3.75MM AND 9 OR 18MM
LENGTHS; MODIFIED
LABELING AND BONDING
PROCESS
P880032/S002 BIO-RAD BIO-RAD CHANGE IN MANUFACTURER
03/01/96 CYCLOSPORINE BY LABORATORIES SITE FOR THE ANALYTICAL
HPLC TEST HERCULES, CA CARTRIDGE AND A CHANGE
94547 IN VENDOR FOR THE
"CLEAN UP" COLUMNS FOR
THE CYCLOSPORINE TEST BY
HPLC
P880081/S020 ULTRAVIOLET- ALLERGAN MEDICAL ADDITION OF STERILIZATION
03/11/96 ABSORBING SILICONE OPTICS SER
VICES OF TENNESSEE (SST)
POSTERIOR CHAMBER IRVINE, CA AS AN ALTERNATE 100% ETO
IOLS 92713-9534 STERILIZATION SITE
P890003/S039 MEDTRONIC MEDTRONIC, INC. NEW MODELS:THERA VDD 8968I:
03/22/96 THERA VDD MODEL MINNEAPOLIS, MN AND PRODIGY MODEL 8168
8968I AND PRODIGY 55432-3576 PULSE GENERATORS,
MODEL 8168 MODEL 5032 CAPSURE VDD LEAD,
PULSE GENERATORS, MODEL 9879E SOFTWARE,
MODEL 5032 AND MODEL 9759 MEMORYMOD
CAPSURE VDD LEAD, MODELS
MODEL 9879E
SOFTWARE, AND
MODEL 9759
MEMORYMOD
P890027/S029 NUCLEUS 22 COCHLEAR CORP COMPONENT REVISIONS,
03/26/96 CHANNEL COCHLEAR ENGLEWOOD, CO LABELING, AND
IMPLANT 80112
MANUFACTURING CHANGES
P890047/S008 PROVISC ALCON LABORATORIES CHANGE IN MANUFACTURING
03/22/96 VISCOELASTIC FORT WORTH, TX SITE AND METHOD; DESIGN
MATERIAL 76134-2099 CHANGE
P890047/S009 DUOVISC ALCON LABORATORIES MANUFACTURE OF DEVICE
03/26/96 VISCOELASTIC SYSTEM FORT WORTH, TX AT ALCON-COUVREUR
76134-2099 (PUURS, BELGIUM) AND
A SINGLE BLISTER PACKAGE
WILL CONTAIN BOTH PROVISC
AND VISCOAT WITH DELIVERY
CANNULAS (24 MONTHS EXP.)
P890056/S004 POSTERIOR CHAMBER ALLERGAN MEDICAL ADDITION OF STERILIZATION
03/11/96 PMMA IOLS OPTICS SERVICES OF TENNESSEE (SST)
IRVINE, CA AS AN ALTERNATE 100% ETO
92713-9534 STERILIZATION SITE
P900023/S016 ABIOMED BVS 5000 ABIOMED, INC. CHANGE TO A COMPONENT
03/12/96 BI-VENTRICULAR DANVERS, MA IN THE BVS 5000 CONSOLE,
SUPPORT SYSTEM 01923 THE HONEYWELL SOLENOID
VALVE, AND EXTENSION OF
THE RECOMMENDED
REPLACEMENT TIME
P900030/S005 CONTIGEN BARD COLLAGEN CORP. MODIFIED PACKAGING
03/08/96 COLLAGEN IMPLANT PALO ALTO, CA CONFIGURATION; LOCATION
94303-3308 CHANGE OF THE SKIN TEST
PACKAGING OPERATION;
REVISION OF WARNING
STATEMENT; AND UPDATING
PATIENT RECORD AND SKIN
TEST CARD LABELING
P900059/S002 ALBUNEX ULTRASOUND MOLECULAR RELEASE OF THE FINAL
03/01/96 CONTRAST BIOSYSTEMS, INC. PRODUCT BASED ON USP
MICROSPHERES SAN DIEGO, CA STERILITY TESTING
92121-2789 PERFORMED BY MOLECULAR
BIOSYSTEM'S, INC.
P910020/S010 RATE ADAPTIVE INTERMEDICS, INC. ALTERNATE ACCELEROMETER
03/15/96 PULSE GENERATORS ANGLETON, TX
77515
P910020/S011 RELAY FAMILY OF INTERMEDICS, INC. CHANGE IN STERILANT
03/22/96 PULSE GENERATORS, ANGLETON, TX FROM A MIXTURE OF 12%
INCL
UDING THE 77515 ETHYLENE OXIDE AND
RELAY, DASH, 88% FREON TO A MIXTURE
STRIDE, DART, OF 8.5% ETHYLENE OXIDE
AND UNITY C AND 91.5% CARBON DIOXIDE
P910020/S014 RELAY/DASH/STRIDE INTERMEDICS, INC. INTRODUCTION OF
03/22/96 STRIDE/DART ANGLETON, TX LABELING ADDRESSING
PACING SYSTEMS 77515 COMPATIBILITY OF
PACEMAKERS WITH
CELLULAR TELEPHONES
P910031/S005 CATHSCANNER ORACLE ENDOSONICS CORP. NEW MODEL: ARC
03/13/96 MICRO PTCA RANCHO CORDOVA, CA CORONARY BALLOON
CATHETER/ARC 95670 DILATATION CATHETER
CORONARY BALLOON
DILATATION CATHETER
P910077/S009 VENTAK PRX III AICD CPI/
GUIDANT CORP. SUBPECTORAL
03/14/96 PULSE GENERATOR ST. PAUL, MN IMPLANTATION OF THE
55112-5798 VENTAK PRX III
PULSE GENERATOR
P920014/S004 TCI HEARTMATE THERMO REVISED LABELING TO
03/13/96 IP LVAS CARDIOSYSTEMS, INC. DELETE THE HEMODYNAMIC
WOBURN, MA CRITERIA FROM THE
01888-2697 INDICATIONS FOR USE
P920015/S005 MEDTRONIC MEDTRONIC, INC. ADDITION OF
03/22/96 MODEL 6937 MINNEAPOLIS, MN MODEL 6937 TRANSVENE
TRANSVENE SUPERIOR 55432-3576 SUPERIOR VENA CAVA LEAD
VENA CAVA LEAD
P920015/S007 MEDTRONIC MEDTRONIC, INC. ADDITION OF MODEL 6934S
03/13/96 MODEL 6934S M
INNEAPOLIS, MN TRANSVENE-RIGHT
TRANSVENE-RIGHT 55432-3576 VENTRICULAR LEAD
VENTRICULAR LEAD
P930014/S002 ACRYSOF MODELS ALCON LABORATORIES ALTERNATE STERILIZATION
03/26/96 MA60BM AND MA30BA FORT WORTH, TX PROCESS INCLUDING AERATION
ULTRAVIOLET- 76134 AND THE ESTABLISHMENT
ABSORBING ACRYLIC OF THE BIOLOGICAL
FOLDABLE INDICATOR INCUBATION
INTRAOCULAR LENSES TIME AT THE HUNTINGTON,
(IOLS) WEST VIRGINIA SITE
P940008/S001 RES-Q ACD INTERMEDICS, INC. ALTERNATE STERILIZATION
03/21/96 MODEL 101-1 ANGLETON, TX PROCESS
AND MODEL 101-01R 77515
P940031/S003 VIGOR GUIDANT CORP. USE OF THE VIGOR
03/21/96
MODEL 2880 SOFTWARE ST. PAUL, MN MODEL 2880 USED IN
APPLICATION 55112-5798 CONJUNCTION WITH THE
MODEL 2909 ON
MODEL 2950 PRM FOR
PROGRAMMING ALL
COMMERCIALLY AVAILABLE
VIGOR PACEMAKERS
***ORIGINAL VETERINARY NADAs***
THERE ARE NO ORIGINAL VETERINARY NADAs FOR MARCH 1996.
***ORIGINAL ABBREVIATED VETERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR MARCH 1996.
***SUPPLEMENTAL VETERINARY NADAs***
THERE ARE NO SUPPLEMENTAL VETERINARY NADAs FOR MARCH 1996.
Date created: July 11, 1996; last updated: June 20, 2005 |
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