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Drug and Device Approvals-March 1995 ***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-092 DILACOR XR RHONE POULENC RORER DILTIAZEM HYDROCHLORIDE
02-MAR-95 (CAPSULE, COLLEGEVILLE, PA 120MG
(SUPPL-005)EXTENDED RELEASE) 19426 180MG
240MG
(NEW INDICATION --
MANAGEMENT OF CHRONIC
STABLE ANGINA)
20-281 ULTRAM JOHNSON RW TRAMADOL HYDROCHLORIDE
03-MAR-95 (TABLET) SPRING HOUSE, PA 50MG
(1 S) 19477 100MG*
(ANALGESIC)
20-364 LOTREL CIBA GEIGY AMLODIPINE BESYLATE
03-MAR-95 (CAPSULE) SUMMIT, NJ EQ 2.5MG BASE
(4 S) 07901 BENAZEPRIL HYDROCHLORIDE
10MG
(ANTIHYPERTENSIVE)
20-364 LOTREL CIBA GEIGY AMLODIPINE BESYLATE
03-MAR-95 (CAPSULE) SUMMIT, NJ EQ 5MG BASE
(4 S) 07901 BENAZEPRIL HYDROCHLORIDE
10MG
(ANTIHYPERTENSIVE)
20-364 LOTREL CIBA GEIGY AMLODIPINE BESYLATE
03-MAR-95 (CAPSULE) SUMMIT, NJ EQ 5MG BASE
(4 S) 07901 BENAZEPRIL HYDROCHLORIDE
20MG
(ANTIHYPERTENSIVE)
* - Not Marketed at This Time
20-409 NASAREL SYNTEX FLUNISOLIDE
08-MAR-95 (SPRAY, METERED) PALO ALTO, CA 0.025MG/INH
(3 S) 94304 (GLUCOCORTICOSTEROID)
[MANAGEMENT OF THE
SYMPTOMS
OF SEASONAL OR
PERENNIAL RHINITIS]
20-164 LOVENOX RHONE POULENC RORER ENOXAPARIN SODIUM
09-MAR-95 (INJECTABLE) COLLEGEVILLE, PA 30MG/0.3ML
(SUPPL-002) 19426 (NEW INDICATION --
PREVENTION OF DEEP
VEIN THROMBOSIS,
WHICH MAY LEAD TO
PULMONARY EMBOLISM,
FOLLOWING
KNEE REPLACEMENT
SURGERY)
20-305 KYTRIL SMITHKLINE BEECHAM GRANISETRON HYDROCHLORIDE
16-MAR-95 (TABLET) KING OF PRUSSIA, PA EQ 1MG BASE
(3 S) 19406 (ANTIEMETIC)
[PREVENTION OF
NAUSEA AND
VOMITING ASSOCIATED WITH
INITIAL AND REPEAT COURSES
OF EMETOGENIC CANCER
THERAPY, INCLUDING
HIGH-DOSE CISPLATIN]
19-842 CHILDREN'S MOTRIN MCNEIL CONS PRODS IBUPROFEN
24-MAR-95 (SUSPENSION) FORT WASHINGTON, PA 100MG/5ML
(SUPPL-004) 19034 (NEW INDICATION --
RELIEF OF MILD TO MODERATE
PAIN IN PATIENTS AGED
6 MONTHS AND OLDER)
20-135 MOTRIN MCNEIL CONS PRODS IBUPROFEN
24-MAR-95 (TABLET, CHEWABLE) FORT WASHINGTON, PA 50MG
(SUPPL-001) 19034 100MG
(NEW INDICATION --
RELIEF OF MILD TO MODERATE
PAIN IN PATIENTS AGED
6 MONTHS AND OLDER)
20-418 MOTRIN MCNEIL CONS PRODS IBUPROFEN
24-MAR-95 (TABLET) FORT WASHINGTON, PA 100MG
(SUPPL-001) 19034 (NEW INDICATION --
RELIEF OF MILD TO MODERATE
PAIN IN PATIENTS AGED
6 MONTHS AND OLDER)
19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM
28-MAR-95 (TABLET) PRINCETON, NJ 40MG
(SUPPL-013) 08543 (NEW STRENGTH)
18-703 ZANTAC 150 GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (TABLET) RES TRIANGLE PK, NC EQ 150MG BASE
(SUPPL-050) 27709 (NEW INDICATION --
MAINTENANCE THERAPY FOR
GASTRIC ULCER PATIENTS AT
REDUCED DOSAGE AFTER HEALING
ACUTE ULCERS)
18-703 ZANTAC 300 GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (TABLET) RES TRIANGLE PK, NC EQ 300MG BASE
(SUPPL-050) 27709 (NEW INDICATION --
MAINTENANCE THERAPY FOR
GASTRIC ULCER PATIENTS AT
REDUCED DOSAGE AFTER HEALING
ACUTE ULCERS)
19-675 ZANTAC GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (SYRUP) RES TRIANGLE PK, NC EQ 15MG BASE/ML
(SUPPL) 27709 (NEW INDICATION --
MAINTENANCE THERAPY FOR
GASTRIC ULCER PATIENTS AT
REDUCED DOSAGE AFTER HEALING
ACUTE ULCERS)
19-943 LUPRON DEPOT TAP PHARMS LEUPROLIDE ACETATE
30-MAR-95 (INJECTABLE) DEERFIELD, IL 3.75MG/VIAL
(6 S) 60015 (GONADOTROPIN RELEASING
HORMONE ANALOG)
[TREATMENT OF ANEMIA CAUSED
BY UTERINE LEIOMYOMATA
IN WOMEN WHO FAIL IRON
THERAPY]
20-225 IMDUR SCHERING ISOSORBIDE MONONITRATE
30-MAR-95 (TABLET, KENILWORTH, NJ 120MG
(SUPPL-001)EXTENDED RELEASE) 07033 (NEW STRENGTH)
20-411 CERVIDIL CONTROLLED THERAP DINOPROSTONE
30-MAR-95 (INSERT, EAST KILBRIDE 10MG
(3 S) EXTENDED RELEASE) UK (PROSTAGLANDIN)
[INITIATION OR CONTINUATION
OF CERVICAL RIPENING IN
PREGNANT WOMEN AT OR
NEAR TERM]
20-439 BETIMOL LEIRAS TIMOLOL
31-MAR-95 (SOLUTION/DROPS) TURKUPANSIONTIE 45-47 EQ 0.25% BASE
(2 S) BOX 145 EQ 0.5% BASE
SF-20101 (BETA ADRENERGIC BLOCKER)
FINLAND
***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.
20-386 COZAAR MERCK LOSARTAN POTASSIUM
02-MAR-95 (TABLET) WEST POINT, PA 25MG
19486 50MG
(ANGIOTENSIN II
RECEPTOR ANTAGONIST)
[HYPERTENSION]
20-169 NILANDRON BESSELAAR ASSOC NILUTAMIDE
07-MAR-95 (TABLET) PRINCETON, NJ 50MG
08540 (ANTIANDROGEN)
[METASTATIC PROSTATE CANCER]
20-173 TRAVASOL 5.5% BAXTER AMINO ACIDS
09-MAR-95 W/ELECTROLYTES ROUND LAKE, IL 5.5%
[SULFITE-FREE] 60073 MAGNESIUM CHLORIDE
IN PLASTIC CONTAINER 102MG/100ML
(INJECTABLE) POTASSIUM PHOSPHATE, DIBASIC
522MG/100ML
SODIUM ACETATE
431MG/100ML
SODIUM CHLORIDE
224MG/100ML
(ELECTROLYTE AND NUTRIENT
REPLENISHER)
20-173 TRAVASOL 8.5% BAXTER AMINO ACIDS
09-MAR-95 W/ELECTROLYTES ROUND LAKE, IL 8.5%
[SULFITE-FREE] 60073 MAGNESIUM CHLORIDE
IN PLASTIC CONTAINER 102MG/100ML
(INJECTABLE) POTASSIUM PHOSPHATE, DIBASIC
522MG/100ML
SODIUM ACETATE
594MG/100ML
SODIUM CHLORIDE
154MG/100ML
(ELECTROLYTE AND NUTRIENT
REPLENISHER)
20-177 TRAVASOL 3.5% BAXTER AMINO ACIDS
09-MAR-95 W/ELECTROLYTES ROUND LAKE, IL 3.5%
[SULFITE-FREE] 60073 MAGNESIUM CHLORIDE
IN PLASTIC CONTAINER 51MG/100ML
(INJECTABLE) POTASSIUM PHOSPHATE, DIBASIC
131MG/100ML
SODIUM ACETATE
218MG/100ML
SODIUM CHLORIDE
35MG/100ML
(ELECTROLYTE AND NUTRIENT
REPLENISHER)
20-387 HYZAAR MERCK LOSARTAN POTASSIUM
10-MAR-95 (TABLET) WEST POINT, PA 50MG
19486 (ANGIOTENSIN II
RECEPTOR ANTAGONIST)
HYDROCHLOROTHIAZIDE
12.5MG
(DIURETIC)
[HYPERTENSION]
20-448 IMODIUM A-D MCNEIL CONS PRODS LOPERAMIDE HYDROCHLORIDE
15-MAR-95 (TABLET, CHEWABLE) FORT WASHINGTON, PA 2MG
19034 (ANTIDIARRHEAL)
(OTC)
20-345 AMINOSYN-HF 8% ABBOTT LABS AMINO ACIDS
17-MAR-95 (INJECTABLE) ABBOTT PARK, IL 8%
60064 (NUTRIENT REPLENISHER)
20-360 HEPATASOL 8% BAXTER AMINO ACIDS
17-MAR-95 (INJECTABLE) ROUND LAKE, IL 8%
60073 (NUTRIENT REPLENISHER)
20-512 AMINO ACIDS 15% CLINTEC NUTRITION AMINO ACIDS
17-MAR-95 [SULFITE-FREE] DEERFIELD, IL 15%
IN PLASTIC CONTAINER 60015 (NUTRIENT REPLENISHER)
(INJECTABLE)
20-132 IMITREX GLAXO SUMATRIPTAN SUCCINATE
30-MAR-95 (TABLET) RES TRIANGLE PK, NC EQ 25MG BASE
27709 EQ 50MG BASE
EQ 100MG BASE
(5-HYDROXYTRYPTAMINE 1
AGONIST)
[ACUTE TREATMENT OF
MIGRAINE ATTACKS]
20-469 VANCENASE AQ SCHERING BECLOMETHASONE DIPROPIONATE
31-MAR-95 (SPRAY, METERED) KENILWORTH, NJ MONOHYDRATE
07033 EQ 0.084MG DIPROP/INH
(CORTICOSTEROID)
[RELIEF OF SYMPTOMS OF
ALLERGIC AND NON-ALLERGIC
RHINITIS]
***ORIGINAL ABBREVIATED NDAs***
74-168 DILTIAZEM HCL ZENITH DILTIAZEM HYDROCHLORIDE
03-MAR-95 (TABLET) NORTHVALE, NJ 30MG
07647 60MG
90MG
120MG
(CALCIUM ION
INFLUX INHIBITOR)
74-230 NAPROXEN SODIUM ZENITH NAPROXEN SODIUM
14-MAR-95 (TABLET) NORTHVALE, NJ EQ 250MG BASE
07647 EQ 500MG BASE
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-319 NAPROXEN SODIUM PUREPAC PHARM NAPROXEN SODIUM
20-MAR-95 (TABLET) ELIZABETH, NJ EQ 250MG BASE
07207 EQ 500MG BASE
(NONSTEROIDAL
ANTI-INFLAMMATORY)
89-595* TRIAMCINOLONE CAROLINA MED TRIAMCINOLONE ACETONIDE
23-MAR-95 ACETONIDE FARMVILLE, NC 0.05%
(OINTMENT) 27828 (CORTICOSTEROID)
74-132 NORTRIPTYLINE HCL LEMMON NORTRIPTYLINE HYDROCHLORIDE
27-MAR-95 (CAPSULE) SELLERSVILLE, PA EQ 10MG BASE
18960 EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
(ANTIDEPRESSANT)
74-259 TRIAMTERENE AND ZENITH HYDROCHLOROTHIAZIDE
30-MAR-95 HYDROCHLOROTHIAZIDE NORTHVALE, NJ 25MG
(CAPSULE) 07647 TRIAMTERENE
50MG
(ANTIHYPERTENSIVE)
* - First Time Product Available Generically
63-333* CEFOBID PFIZER CEFOPERAZONE SODIUM
31-MAR-95 (INJECTABLE) NEW YORK, NY EQ 1GM BASE/VIAL
10017 EQ 2GM BASE/VIAL
(ANTIBIOTIC, CEPHEM)
64-062 AMPHOTERICIN B GENSIA LABS AMPHOTERICIN B
31-MAR-95 (INJECTABLE) IRVINE, CA 50MG/VIAL
92718 (ANTIFUNGAL)
74-221 EMBELINE DPT CLOBETASOL PROPIONATE
31-MAR-95 (OINTMENT) SAN ANTONIO, TX 0.05%
78215 (CORTICOSTEROID)
74-419 AZATHIOPRINE SODIUM BEDFORD LABS AZATHIOPRINE SODIUM
31-MAR-95 (INJECTABLE) BEDFORD, OH EQ 100MG BASE/VIAL
44146 (IMMUNOSUPPRESSIVE)
74-472* CAPTOPRIL APOTHECON CAPTOPRIL
31-MAR-95 (TABLET) PRINCETON, NJ 12.5MG
08543 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME 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.
74-322 CAPTOPRIL NOVOPHARM CAPTOPRIL
20-MAR-95 (TABLET) WILSON, NC 12.5MG
27396 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-434 CAPTOPRIL MYLAN CAPTOPRIL
22-MAR-95 (TABLET) MORGANTOWN, WV 12.5MG
26505 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-451 CAPTOPRIL ROYCE LABS CAPTOPRIL
31-MAR-95 (TABLET) MIAMI, FL 12.5MG
33014 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
17-661 TAVIST-1 SANDOZ CLEMASTINE FUMARATE
03-FEB-95 (TABLET) EAST HANOVER, NJ 1.34MG
07936 (LABELING REVISION --
OTC LABEL)
(OTC)
18-298 TAVIST-D SANDOZ CLEMASTINE FUMARATE
03-FEB-95 (TABLET, EAST HANOVER, NJ 1.34MG
EXTENDED RELEASE) 07936 PHENYLPROPANOLAMINE HYDROCHLORIDE
75MG
(LABELING REVISION --
OTC LABEL)
(OTC)
20-001 FS HILL DERMA FLUOCINONIDE ACETONIDE
16-FEB-95 (SHAMPOO) ORLANDO, FL 0.01%
32801 (LABELING REVISION --
CLINICAL STUDIES;
PRECAUTIONS;
ADVERSE REACTIONS)
13-731 BILOPAQUE NYCOMED TYROPANOATE SODIUM
22-FEB-95 (CAPSULE) NEW YORK, NY 750MG
10016 (LABELING REVISION --
DESCRIPTION)
12-787 FLUOCINOLONE ACETONIDE HAMILTON PHARMA FLUOCINOLONE ACETONIDE
01-MAR-95 (CREAM) PALO ALTO, CA 0.01%
94303 0.025%
(LABELING REVISION --
ADDITIONAL PACKAGE INSERT;
HOW SUPPLIED)
16-908 FLUOCINONIDE HAMILTON PHARMA FLUOCINONIDE
01-MAR-95 (CREAM) PALO ALTO, CA 0.05%
94303 (LABELING REVISION --
ADDITIONAL PACKAGE INSERT;
HOW SUPPLIED)
16-908 FLUOCINONIDE HAMILTON PHARMA FLUOCINONIDE
01-MAR-95 EMOLLIENT BASE PALO ALTO, CA 0.05%
(CREAM) 94303 (LABELING REVISION --
ADDITIONAL PACKAGE INSERT;
HOW SUPPLIED)
18-849 FLUOCINONIDE HAMILTON PHARMA CA FLUOCINONIDE
01-MAR-95 (SOLUTION) PALO ALTO, CA 0.05%
94303 (LABELING REVISION --
ADDITIONAL PACKAGE INSERT;
HOW SUPPLIED)
18-936 PROZAC LILLY FLUOXETINE HYDROCHLORIDE
01-MAR-95 (CAPSULE) INDIANAPOLIS, IN EQ 10MG BASE
46285 EQ 20MG BASE
(LABELING REVISION --
ADVERSE REACTIONS;
HOW SUPPLIED)
19-901 ALTACE HOECHST ROUSSEL RAMIPRIL
01-MAR-95 (CAPSULE) SOMERVILLE, NJ 1.25MG
08876 2.5MG
5MG
10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
20-101 PROZAC LILLY FLUOXETINE HYDROCHLORIDE
01-MAR-95 (SOLUTION) INDIANAPOLIS, IN EQ 20MG BASE/5ML
46285 (LABELING REVISION --
ADVERSE REACTIONS)
20-460 CYTOVENE SYNTEX GANCICLOVIR
01-MAR-95 (CAPSULE) PALO ALTO, CA 250MG
94304 (LABELING REVISION --
DESCRIPTION;
INDICATIONS AND USAGE;
PRECAUTIONS; ADVERSE EVENTS;
CLINICAL PHARMACOLOGY;
HOW SUPPLIED)
13-960 FLUOCINONIDE ACETONIDE HAMILTON PHARMA FLUOCINONIDE ACETONIDE
02-MAR-95 (OINTMENT) PALO ALTO, CA 0.025%
94303 (LABELING REVISION --
ADDITIONAL PACKAGE INSERT;
PRECAUTIONS;
HOW SUPPLIED)
13-960 SYNALAR HAMILTON PHARMA FLUOCINONIDE ACETONIDE
02-MAR-95 (OINTMENT) PALO ALTO, CA 0.025%
94303 (LABELING REVISION --
PRECAUTIONS)
20-092 DILACOR XR RHONE POULENC RORER DILTIAZEM HYDROCHLORIDE
02-MAR-95 (CAPSULE, COLLEGEVILLE, PA 120MG
EXTENDED RELEASE) 19426 180MG
240MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
16-908 LIDEX HAMILTON FLUOCINONIDE
03-MAR-95 (CREAM) PALO ALTO, CA 0.05%
94303 (LABELING REVISION --
PRECAUTIONS)
16-908 LIDEX-E HAMILTON FLUOCINONIDE
03-MAR-95 (CREAM) PALO ALTO, CA 0.05%
94303 (LABELING REVISION --
PRECAUTIONS)
20-357 GLUCOPHAGE BRISTOL MYERS SQUIBB METFORMIN HYDROCHLORIDE
03-MAR-95 (TABLET) PRINCETON, NJ 500MG
08543 850MG
(LABELING REVISION --
PATIENT PACKAGE INSERT)
12-787 SYNALAR HAMILTON FLUOCINOLONE ACETONIDE
06-MAR-95 (CREAM) PALO ALTO, CA 0.01%
94303 (LABELING REVISION --
PRECAUTIONS)
12-787 SYNEMOL HAMILTON FLUOCINOLONE ACETONIDE
06-MAR-95 (CREAM) PALO ALTO, CA 0.025%
94303 (LABELING REVISION --
PRECAUTIONS)
15-296 SYNALAR SYNTEX FLUOCINOLONE ACETONIDE
06-MAR-95 (SOLUTION) PALO ALTO, CA 0.01%
94304 (LABELING REVISION --
PRECAUTIONS)
19-927 NIZORAL JANSSEN KETOCONAZOLE
06-MAR-95 (SHAMPOO) TITUSVILLE, NJ 2%
08560 (LABELING REVISION --
DESCRIPTION)
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
09-MAR-95 (CAPSULE, WAYNE, PA 20MG
DELAYED RELEASE) 19087 (LABELING REVISION --
PELLETS) WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS)
20-164 LOVENOX RHONE POULENC RORER ENOXAPARIN SODIUM
09-MAR-95 (INJECTABLE) COLLEGEVILLE, PA 30MG/0.3ML
19426 (LABELING REVISION --
DESCRIPTION;
CLINICAL TRIALS;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS)
20-032 SURVANTA ROSS LABS BERACTANT
10-MAR-95 (SUSPENSION) COLUMBUS, OH 25MG/ML
43215 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
18-938 DDAVP RHONE POULENC RORER DESMOPRESSIN ACETATE
13-MAR-95 (INJECTABLE) FORT WASHINGTON, PA 0.004MG/ML
19034 (LABELING REVISION --
DESCRIPTION;
CONTRAINDICATIONS;
PRECAUTIONS)
50-526 STATICIN WESTWOOD SQUIBB ERYTHROMYCIN
13-MAR-95 (SOLUTION) BUFFALO, NY 1.5%
14213 (LABELING REVISION --
DESCRIPTION; WARNINGS;
PRECAUTIONS;
ADVERSE REACTIONS)
18-849 LIDEX HAMILTON PHARMA CA FLUOCINONIDE
14-MAR-95 (SOLUTION) PALO ALTO, CA 0.05%
93303 (LABELING REVISION --
PRECAUTIONS)
16-931 R-GENE 10 PHARMACIA ARGININE HYDROCHLORIDE
15-MAR-95 (INJECTABLE) COLUMBUS, OH 10GM/100ML
43216 (LABELING REVISION --
WARNINGS; OVERDOSAGE)
10-379 CYTOMEL SMITHKLINE BEECHAM LIOTHYRONINE SODIUM
17-MAR-95 (TABLET) PHILADELPHIA, PA EQ 0.005MG BASE
19101 EQ 0.025MG BASE
EQ 0.05MG BASE
(LABELING REVISION --
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-762 BRETHAIRE GEIGY TERBUTALINE SULFATE
17-MAR-95 (AEROSOL, METERED) ARDSLEY, NY 0.2MG/INH
10502 (LABELING REVISION --
HOW SUPPLIED)
19-880 PARAPLATIN BRISTOL MYERS SQUIBB CARBOPLATIN
17-MAR-95 (INJECTABLE) BUFFALO, NY 50MG/VIAL
14213 150MG/VIAL
450MG/VIAL
(LABELING REVISION --
DOSAGE AND ADMINISTRATION)
07-517 TAPAZOLE LILLY METHIMAZOLE
20-MAR-95 (TABLET) INDIANAPOLIS, IN 5MG
46285 10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
17-122 DARVOCET-N 50 LILLY ACETAMINOPHEN
20-MAR-95 (TABLET) INDIANAPOLIS, IN 325MG
46285 PROPOXYPHENE NAPSYLATE
50MG
(LABELING REVISION --
DESCRIPTION)
17-122 DARVOCET-N 100 LILLY ACETAMINOPHEN
20-MAR-95 (TABLET) INDIANAPOLIS, IN 650MG
46285 PROPOXYPHENE NAPSYLATE
100MG
(LABELING REVISION --
DESCRIPTION)
16-831 EFUDEX ROCHE FLUOROURACIL
21-MAR-95 (CREAM) NUTLEY, NJ 5%
07110 (LABELING REVISION --
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
PRECAUTIONS)
16-831 EFUDEX ROCHE FLUOROURACIL
21-MAR-95 (SOLUTION) NUTLEY, NJ 2%
07110 5%
(LABELING REVISION --
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
PRECAUTIONS)
50-587 PRIMAXIN MSD CILASTATIN SODIUM
21-MAR-95 (INJECTABLE) WEST POINT, PA EQ 250MG BASE/VIAL
19486 IMIPENEM
250MG/VIAL
(LABELING REVISION --
COMPATIBILITY AND STABILITY)
50-587 PRIMAXIN MSD CILASTATIN SODIUM
21-MAR-95 (INJECTABLE) WEST POINT, PA EQ 500MG BASE/VIAL
19486 IMIPENEM
500MG/VIAL
(LABELING REVISION --
COMPATIBILITY AND STABILITY)
06-035 METHERGINE SANDOZ METHYLERGONOVINE MALEATE
22-MAR-95 (TABLET) EAST HANOVER, NJ 0.2MG
07936 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
ADVERSE REACTIONS;
WARNINGS; PRECAUTIONS)
06-035 METHERGINE SANDOZ METHYLERGONOVINE MALEATE
22-MAR-95 (INJECTABLE) EAST HANOVER, NJ 0.2MG/ML
07936 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
ADVERSE REACTIONS;
WARNINGS; PRECAUTIONS)
18-243 OXYTOCIN WYETH AYERST OXYTOCIN
22-MAR-95 (INJECTABLE) PHILADELPHIA, PA 10 USP UNITS/ML
19101 (LABELING REVISION --
PRECAUTIONS)
19-860 IMODIUM A-D MCNEIL CONS PRODS LOPERAMIDE
22-MAR-95 (TABLET) FORT WASHINGTON, PA 2MG
19034 (LABELING REVISION --
OTC LABELING)
(OTC)
20-219 LIVOSTIN CIBA VISION LEVACABASTINE HYDROCHLORIDE
23-MAR-95 (SUSPENSION) DULUTH, GA EQ 0.05% BASE
30136 (LABELING REVISION --
PRECAUTIONS; HOW SUPPLIED)
10-060 FLORINEF APOTHECON FLUDROCORTISONE ACETATE
24-MAR-95 (TABLET) PRINCETON, NJ 0.1MG
08543 (LABELING REVISION --
ADVERSE REACTIONS)
16-099 ATROMID-S WYETH AYERST CLOFIBRATE
24-MAR-95 (CAPSULE) PHILADELPHIA, PA 500MG
19101 (LABELING REVISION --
WARNINGS; PRECAUTIONS)
18-422 LOPID PARKE DAVIS GEMFIBROZIL
24-MAR-95 (TABLET) MORRIS PLAINS, NJ 600MG
07950 (LABELING REVISION --
ADVERSE REACTIONS;
OVERDOSAGE)
19-842 CHILDREN'S MOTRIN MCNEIL CONS PRODS IBUPROFEN
24-MAR-95 (SUSPENSION) FORT WASHINGTON, PA 100MG/5ML
19034 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
19-970 NITROGLYCERIN BAXTER HLTHCARE NITROGLYCERIN
24-MAR-95 IN DEXTROSE 5% ROUND LAKE, IL 10MG/100ML
(INJECTABLE) 60073 20MG/100ML
40MG/100ML
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
20-135 MOTRIN MCNEIL CONS PRODS IBUPROFEN
24-MAR-95 (TABLET, CHEWABLE) FORT WASHINGTON, PA 50MG
19034 100MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
20-144* TRANSDERM-NITRO CIBA NITROGLYCERIN
24-MAR-95 (FILM, SUMMIT, NJ 0.1MG/HR
EXTENDED RELEASE) 07901 0.2MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
(LABELING REVISION --
ADVERSE REACTIONS)
20-263 LUPRON DEPOT-PED TAP PHARMS LEUPROLIDE ACETATE
24-MAR-95 (SUSPENSION) DEERFIELD, IL 7.5MG/VIAL
60015 11.25MG/VIAL
15MG/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY)
* - Permitted
20-418 MOTRIN MCNEIL CONS PRODS IBUPROFEN
24-MAR-95 (TABLET) FORT WASHINGTON, PA 100MG
19034 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
19-961 GANITE FUJISAWA GALLIUM NITRATE
27-MAR-95 (INJECTABLE) MELROSE PARK, IL 25MG/ML
60160 (LABELING REVISION --
ADVERSE REACTIONS)
19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM
28-MAR-95 (TABLET) PRINCETON, NJ 10MG
08543 20MG
40MG
(LABELING REVISION --
DESCRIPTION;
HOW SUPPLIED)
17-604 NALFON DISTA PRODS FENOPROFEN CALCIUM
29-MAR-95 (CAPSULE) INDIANAPOLIS, IN EQ 200MG BASE
46206 EQ 300MG BASE
(LABELING REVISION --
DESCRIPTION;
ADVERSE REACTIONS)
17-710 NALFON DISTA PRODS FENOPROFEN CALCIUM
29-MAR-95 (TABLET) INDIANAPOLIS, IN EQ 600MG BASE
46206 (LABELING REVISION --
DESCRIPTION;
ADVERSE REACTIONS)
18-703 ZANTAC 150 GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (TABLET) RES TRIANGLE PK, NC EQ 150MG BASE
27709 (LABELING REVISION --
INDICATIONS AND USAGE;
DOSAGE AND ADMINISTRATION)
18-703 ZANTAC 300 GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (TABLET) RES TRIANGLE PK, NC EQ 300MG BASE
27709 (LABELING REVISION --
INDICATIONS AND USAGE;
DOSAGE AND ADMINISTRATION)
19-675 ZANTAC GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (SYRUP) RES TRIANGLE PK, NC EQ 15MG BASE/ML
27709 (LABELING REVISION --
INDICATIONS AND USAGE;
DOSAGE AND ADMINISTRATION)
20-095 ZANTAC 150 GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (CAPSULE) RES TRIANGLE PK, NC EQ 150MG BASE
27709 (LABELING REVISION --
INDICATIONS AND USAGE;
DOSAGE AND ADMINISTRATION)
20-095 ZANTAC 300 GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (CAPSULE) RES TRIANGLE PK, NC EQ 300MG BASE
27709 (LABELING REVISION --
INDICATIONS AND USAGE;
DOSAGE AND ADMINISTRATION)
20-251 ZANTAC 150 GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (GRANULE, RES TRIANGLE PK, NC EQ 150MG BASE/PKT
EFFERVESCENT) 27709 (LABELING REVISION --
INDICATIONS AND USAGE;
DOSAGE AND ADMINISTRATION)
20-251 ZANTAC 150 GLAXO RANITIDINE HYDROCHLORIDE
29-MAR-95 (TABLET, RES TRIANGLE PK, NC EQ 150MG BASE
EFFERVESCENT) 27709 (LABELING REVISION --
INDICATIONS AND USAGE;
DOSAGE AND ADMINISTRATION)
11-679 PENTOTHAL ABBOTT THIOPENTAL SODIUM
30-MAR-95 (SUSPENSION) ABBOTT PARK, IL 400MG/GM
60064 (LABELING REVISION --
CONTRAINDICATIONS;
PRECAUTIONS;
ADVERSE REACTIONS)
17-820 DOBUTREX LILLY DOBUTAMINE HYDROCHLORIDE
30-MAR-95 (INJECTABLE) INDIANAPOLIS, IN EQ 12.5MG BASE/ML
46285 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS;
HOW SUPPLIED)
19-898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM
30-MAR-95 (TABLET) PRINCETON, NJ 10MG
08543 20MG
40MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY)
20-225 IMDUR SCHERING ISOSORBIDE MONONITRATE
30-MAR-95 (TABLET, KENILWORTH, NJ 60MG
EXTENDED RELEASE) 07033 120MG
(LABELING REVISION --
DESCRIPTION; PRECAUTIONS;
HOW SUPPLIED)
19-777 ZESTRIL ZENECA (UK) LISINOPRIL
31-MAR-95 (TABLET) MACCLESFIELD, 5MG
UNITED KINGDOM 10MG
20MG
40MG
(LABELING REVISION --
ADVERSE REACTIONS)
19-888 ZESTORETIC 10-12.5 ZENECA (UK) HYDROCHLOROTHIAZIDE
31-MAR-95 (TABLET) MACCLESFIELD, 12.5MG
UNITED KINGDOM LISINOPRIL
10MG
(LABELING REVISION --
ADVERSE REACTIONS)
19-888 ZESTORETIC 20-12.5 ZENECA (UK) HYDROCHLOROTHIAZIDE
31-MAR-95 (TABLET) MACCLESFIELD, 12.5MG
UNITED KINGDOM LISINOPRIL
20MG
(LABELING REVISION --
ADVERSE REACTIONS)
19-888 ZESTORETIC 20-25 ZENECA (UK) HYDROCHLOROTHIAZIDE
31-MAR-95 (TABLET) MACCLESFIELD, 25MG
UNITED KINGDOM LISINOPRIL
20MG
(LABELING REVISION --
ADVERSE REACTIONS)
19-891 DILAUDID KNOLL PHARM HYDROMORPHONE HYDROCHLORIDE
31-MAR-95 (SOLUTION) WHIPPANY, NJ 5MG/5ML
07981 (LABELING REVISION --
SAFETY AND HANDLING)
19-892 DILAUDID KNOLL PHARM HYDROMORPHONE HYDROCHLORIDE
31-MAR-95 (TABLET) WHIPPANY, NJ 8MG
07981 (LABELING REVISION --
SAFETY AND HANDLING)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
1182 NONE BEACH STREET LAB SOURCE PLASMA
09-MAR-95 (NONE) HOLLY HILL, FL (A,B)
32117
0002 VARIVAX MERCK VARICELLA VIRUS VACCINE LIVE
17-MAR-95 (INJECTABLE) WEST POINT, PA (IMMUNIZATION AGAINST
19486 CHICKENPOX IN INDIVIDUALS
12 MONTHS AND OLDER)
(B)
0580 WinRho SD RH PHARMS Rho(D) IMMUNE GLOBULIN
24-MAR-95 (INJECTABLE) WINNIPEG, CANADA INTRAVENOUS (HUMAN)
R3T 2N2 (TREATMENT OF ACUTE/
CHRONIC ITP, ITP SECONDARY TO
HIV INFECTIONS, AND SUPPRESSION
OF Rh ISOIMMUNIZATION)
(B)
0140 NONE BAXTER CMV HIGH TITER FRACTION II+III
31-MAR-95 (NONE) GLENDALE, CA PASTE
91203 (FOR FURTHER
MANUFACTURING USE)
(B)
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK940051 HELMER WATER HELMER LABS HELMER WATER
03-MAR-95 PLASMA THAWER NOBLESVILLE, IN PLASMA WARMER
46060 (C)
BK940029 SCIMED ULTRAFUSE SCIMED LIFE SYS CORONARY INFUSION/
15-MAR-95 MAPLE GROVE, MN GUIDE WIRE EXCHANGE
55311 CATHETER (MODELS 4CM AND 8CM)
(C)
BK940054 SEG-SAFE ALPHA SCI SEAGMENT DISPENSER
15-MAR-95 SOUTHEASTERN, PA (C)
19399
BK950010 CENTOCOR CAPTIA CENTOCOR ANTIBODY TEST FOR CMV
22-MAR-95 MALVERN, PA (C)
19355
(C) Substantially Equivalent
***MEDICAL DEVICE - PREMARKET APPROVAL APPLICATIONS***
THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH AND IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIOR
TO PUBLICATION
P910067 EXIMED UV200LA SUMMIT TECHNOLOGY, INC. INDICATED FOR USE IN
03/10/95 EXCIMER LASER WALTHAM, MA PHOTOTHERAPEUTIC
SYSTEM SVS APEX 02154 KERATECTOMY (PTK)
EXCIMER LASER SYSTEM PROCEDURES UNDER
CERTAIN CONDITIONS
P920055 BOSTON ADVANCE POLYMER TECHNOLOGY INDICATED FOR
03/01/95 COMFORT FORMULA DIV WILMINGTON PART L.P. DISINFECTING AND
CONDITIONING WILMINGTON, MA SOAKING FLOURO
SOLUTION 01887 SILICONE ACRYLATE AND
SILICONE ACRYLATE
RIGID GAS PERMEABLE
CONTACT LENSES
P930035 VENTAK P2 AICD CARDIAC PACEMAKERS,INC. INDICATED FOR THE
03/10/95 SYSTEM MODEL ST. PAUL, MN TREATMENT OF PATIENTS
1625 VENTAK P2 55112-5798 WITH VENTRICULAR
PULSE GENERATOR, FIBRILLATION AND/OR
MODEL 2835 VENTRICULAR
SOFTWARE MODULE, TACHYARRHYTHMIAS WHO
MODEL 2815 VENTAK ECD ARE AT HIGH RISK OF
EXTERNAL CARDIOVERTER SUDDEN CARDIAC DEATH
DEFIBRILLATOR
***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
N50510/S061 VITEK SYSTEMS BIOMERIEUX VITEK, INC. REMOVAL OF THE
03/01/95 GENERAL HAZELWOOD, MO DISCLAIMER FOR
SUSCEPTIBILITY CARD 63042-2395 PSEUDOMONAS/AZTREONAM
P810002/S33 ST. JUDE MEDICAL ST.JUDE MEDICAL, INC. USE OF GENERAL
03/14/95 MECHANICAL HEART ST. PAUL, MN SUTURING INSTRUCTIONS
VALVE 55117 IN LIEU OF SPECIFIC
SUTURING INSTRUCTIONS
P810025/S15 AMVISC AND IOLAB CORPORATION ALTERNATE ANIMAL
03/10/95 AMVISC PLUS CLAREMONT, CA MODEL FOR
91711 INFLAMMATORY TESTING
OF AMVISC AND AMVISC
PLUS VISCOELASTICS
P810046/S151SIMPSON-ROBERT ADVANCED CHANGES IN THE
03/23/95 CORONARY BALLOON CARDIOVASCULAR SYSTEMS INSTRUCTIONS FOR USE
DILATATION CATHETER SANTA CLARA, CA
ACS STACK 95052-8167
PERFUSION CORONARY
DILATATION CATHETER
P810046/S153SIMPSON-ROBERT ADVANCED MATERIAL
03/23/95 CORONARY BALLOON CARDIOVASCULAR SYSTEMS MANUFACTURING AND
DILATATION SANTA CLARA, CA LABELING CHANGES TO
CATHETER ACS RX 95052-8167 THE ACS RX PRIMAFLOW
LIFESTREAM CORONARY CORONARY DILATATION
DILATATION CATHETER CATHETER
P820021/S026NEWVUEW, NEWVUES CIBA VISION CORP. ADD THE MONOVISION
03/31/95 SOFTCOLORS, FOCUS ATLANTA, GA FITTING TECHNIQUE TO
VISITINT, FOCUS 30360 THE LABELING OF A
SOFTCOLORS SINGLE VISION CONTACT
HYDROPHILIC LENS TO MANAGE
CONTACT LENSES PRESBYOPIA
P820060/S8 ABBOTT AXSYM AFP ABBOTT LABORATORIES MODIFICATIONS TO THE
03/27/95 ABBOTT PARK, IL ABBOTT AFP EIA DEVICE
60024-3500 TO FACILITATE THE USE
OF THE ASSAY ON THE
ABBOTT AXSYM ANALYZER
NEW TRADE NAME ABBOTT
AXSYM AFP
P830026/S61 MODEL 522-12 INTERMEDICS, INC. APPROVAL FOR THE
03/09/95 RX5000 PROGRAMMER ANGLETON, TX RX5000 MODEL 522-12
77515 PROGRAMMER WITH
ACCESSORIES
P830045/S47 MODEL 3202A SIEMENS PACESETTER,INC. APPROVAL FOR THE
03/27/95 FUNCTION PACK SYLMAR, CA MODEL 3202A FUNCTION
91392-9221 PACK FOR USE WITH THE
APS II MODEL 3003
PROGRAMMER
P830066/S11 ABBOTT AXSYM CEA ABBOTT LABORATORIES MODIFICATIONS TO THE
03/27/95 ABBOTT PARK, IL ABBOTT CEA EIA DEVICE
60064-3500 TO FACILITATE THE USE
OF THE ASSAY ON THE
ABBOTT AXSYM ANALYZER
NEW TRADE NAME AXSYM
CEA
P840068/S22 SSI PACEMAKER CARDIAC PACEMAKERS INC. VIGOR SSI PACEMAKER
03/15/95 SYSTEM WITH ST PAUL, MN SYSTEM WITH
MODELS 460 AND 465 55112 MODELS 460 AND 465
PULSE GENERATORS, PULSE GENERATORS
AND MODEL 2055 AND MODEL 2055
SOFTWARE MODULE SOFTWARE MODULE
P850051/S45 MEDTRONIC SINGLE MEDTRONIC INC. USE OF TECOTHANE 75D
03/01/95 CHAMBER PACEMAKERS MINNEAPOLIS, MN POLYURETHANE RESIN,
55432-3576 PRODUCED BY
THERMEDICS, INC.
ALTERNATE MATERIAL
FOR THE PELLETHANE
75D RESIN FOR THE
CONNECTOR MODULE
P860007/S15 INTERTACH II INTERMEDICS, INC. USE OF WILSON
03/01/95 MODELS 262-16 ANGLETON, TX GREATBACH BATTERIES/
77515 MODIFICATION BATTERY
SPECIFICATIONS
P860012/S5 ALVEOFORM COLLAGEN CORPORATION ALTERNATE
03/21/95 BIOGRAFT IMPLANT PALO ALTO, CA MANUFACTURING PROCESS
94303 FOR ALVEOFORM
BIOGRAFT IMPLANT
P880003/S32 TITAN 18 PTCA CORDIS CORPORATION APPROVAL FOR A TEAL
03/09/95 DILATATION CATHETER MIAMI, FL OUTER BODY, A RATED
33102-5700 BURST PRESSURE OF
SIXTEEN (16) ATM, A
MODIFIED ATTACHMENT
OF THE BALLOON
MARKERBAND, LENGTHS
OF 9 AND 18 MM
P880003/S33 CORDIS PTCA CORDIS CORPORATION MODIFICATION OF THE
03/21/95 DILATATION CATHETER MIAMI,FL EXIT MARKER MATERIAL
TRAKSTAR PTCA 33102-5700 AND APPLICATION
DILATATION CATHETERS PROCESS
P880006/S21 MODEL 3202A SIEMENS PACESETTER,INC. APPROVAL FOR THE
03/27/95 FUNCTION PACK SYLMAR, CA MODEL 3202A FUNCTION
91392-9221 PACK FOR THE USE WITH
THE APS II MODEL 3003
PROGRAMMER
P880027/S31 SCHNEIDER PFIZER HOSPITAL USE OF THE DYMAX 190M
03/24/95 MICROSOFTRAC PTCA PRODUCTS GROUP AS THE HUB-TO-STYLET
CATHETER SCHNEIDER MINNEAPOLIS, MN RETAINER ADHESIVE AND
FREEHAND AND MC 55442 AN ADDITION TO THE
RAIL 20/30/40 DEVICE LABELING
PTCA CATHETERS
P880027/S32 SCHNEIDER PFIZER HOSPITAL ALTERNATE DESIGN OF
03/23/95 MICROSOFTRAC PRODUCTS GROUP THE OVER-THE-WIRE
PTCA CATHETERS MINNEAPOLIS, MN SCHNEIDER MYSTIC PTCA
SCHNEIDER FREELIGHT 55442 CATHETERS NEW TRADE
PTCA CATHETERS NAMES SCHNEIDER
FREELIGHT 20, 30, 40
RCA CATHETERS
P880027/S33 SCHNEIDER PFIZER HOSPITAL ALTERNATIVE DESIGN OF
03/24/95 MICROSOFTRAC PRODUCTS GROUP THE SCHNEIDER FREEHAND
PTCA CATHETER MINNEAPOLIS, MN PTCA CATHETER, NEW
FREEHAND 20/30/40 55442 TRADE NAMES FREEHAND
PTCA CATHETERS 20, FREEHAND 30, AND
FREEHAND 40
PTCA CATHETERS
P880086/S29 MODEL 3202A SIEMENS PACESETTER,INC. APPROVAL FOR THE
03/27/95 FUNCTION PACK SYLMAR, CA MODEL 3202A FUNCTION
91392-9221 PACK FOR USE WITH THE
APS II MODEL 3003
PROGRAMMER
P880090/S12 STORZ MODEL 120 STORZ OPHTHALMICS, INC. LABELING CHANGES FOR
03/31/95 UV AND NON-UV CLEARWATER, FL THE MODELS 120 AND
ABSORBING 34619 120 UV INTRAOCULAR
INTRAOCULAR LENS LENSES
FAMILY FOR
ANTERIOR OR
POSTERIOR CHAMBER
PLACEMENT
P890003/S32 MEDTRONIC DUAL MEDTRONIC, INC. USE OF TECOTHANE 75D
03/01/95 CHAMBER PACEMAKERS MINNEAPOLIS, MN POLYURETHANE RESIN,
55432-3576 PRODUCED BY
THERMEDICS, INC. AS
AN ALTERNATE MATERIAL
FOR PELLETHANE 75D
RESIN FOR THE
CONNECTOR MODULE
P890057/S5 MODEL 3100A HIGH SENSORMEDICS CORPORATION SEVERAL DESIGN
03/23/95 FREQUENCY YORBA LINDA, CA CHANGES
OSCILLATORY 92687
VENTILATOR
P900023/S14 ABIOMED BVS 5000 ABIOMED, INC. ADDITIONAL SIZE
03/23/95 BI-VENTRICULAR DANVERS, MA ATRIAL CANNULA,
SUPPORT SYSTEM 01923 THE 36 FRENCH FLANGED
BENDABLE ATRIAL
CANNULA, TO BE USED
WITH THE BVS 5000
BI-VENTRICULAR
SUPPORT SYSTEM
P900030/S3 CONTIGEN BARD COLLAGEN CORPORATION USE OF BARD
03/03/95 COLLAGEN IMPLANT PALO ALTO, CA TRANSURETHRAL
94303-3308 INJECTION SYSTEM KIT
P900039/S6 COLLAGRAFT BONE COLLAGEN CORPORATION ALTERNATE
03/21/95 GRAFT MATRIX PALO ALTO, CA MANUFACTURING PROCESS
94303-3308 FOR THE COLLAGRAFT
BONE GRAFT MATRIX
P900061/S7 MEDTRONIC MODEL MEDTRONIC, INC. MEDTRONIC MODEL 7219D
03/17/95 7219D JEWEL PCD MINNEAPOLIS, MN JEWEL PCD ARRHYTHMIA
ARRHYTHMIA CONTROL 55432-3576 CONTROL SYSTEM
SYSTEM
P910001/S9 SPECTRANETICS SPECTRANETICS CORPORATION MODIFICATIONS TO THE
03/24/95 CVX-300 EXCIMER COLORADO SPRINGS, CO INNER LUMEN AND TIP
LASER SYSTEM 80907 OF THE METAL RIM
CATHETER MODELS
PC1014M, 114-001,
PC1017M, 117-002,
PC1120M, AND 120-001
P910007/S2 ABBOTT AXSYM PSA ABBOTT LABORATORIES MODIFICATIONS TO THE
03/29/95 ABBOTT PARK, IL ABBOTT PSA EIA DEVICE
60064-3500 TO FACILITATE THE
USE OF THE ASSAY ON
THE ABBOTT AXSYM
ANALYZER
P910020/S9 RELAY/DASH/ INTERMEDICS, INC. USE OF WILSON
03/01/95 STRIDE/DART ANGLETON, TX GREATBATCH BATTERIES/
PACING SYSTEMS 77515 MODIFICATION OF THE
BATTERY SPECIFICATIONS
P910056/S1 MODELS C24UB, CHIRON VISION APPROVAL OF THE
03/31/95 C29UB, C31UB, AND CORPORATION CHIROFLEX MODELS
C33UB ULTRAVIOLET- IRVINE, CA C24UB, C29UB, C31UB
ABSORBING SILICONE 92718-1903 ULTRAVIOLET-ABSORBING
POSTERIOR CHAMBER SILICONE POSTERIOR
INTRAOCULAR LENSES CHAMBER INTRAOCULAR
LENSES
P910058/S1 MODEL C10UB CHIRON VISION APPROVAL FOR THE
03/29/95 ULTRAVIOLET- IRVINE, CA CHIROFLEX MODEL C10UB
ABSORBING 92718-1903 ULTRAVIOLET-ABSORBING
SILICONE SILICONE POSTERIOR
POSTERIOR CHAMBER CHAMBER INTRAOCULAR
INTRAOCULAR LENS LENS AND FOR
STAAR SURGICAL
COMPANY TO DISTRIBUTE
P910075/S2 COMPLETE BRAND ALLERGEN OPTICAL USE OF COMPLETE BRAND
03/23/95 LUBRICATING AND IRVINE, CA MULTI-PURPOSE
REWETTING DROPS 92713-0534 SOLUTION AS
LUBRICATING AND
REWETTING DROPS,
NEW TRADE NAME COMPLETE
BRAND LUBRICATING AND
REWETTING DROPS
***ORIGINAL VETERINARY NADAs***
THERE ARE NO ORIGINAL VETERINARY NADAs FOR MARCH 1995.
***ORIGINAL ABBREVIATED VETERINARY NADAs***
200-123 MAXIM 200 CATTLE, PHOENIX SCIENTIFIC OXYTETRACYCLINE
10-FEB-95 (LIQUID) SWINE ST JOSEPH, MO 200MG/ML
64506
200-050 NEOMYCIN 325 CATTLE, SANOFI AN HLTH NEOMYCIN SULFATE
15-FEB-95 (POWDER) GOATS, OVERLAND PK, KS 25GM/1.76OZ
SHEEP, 62210 50GM/3.5OZ
SWINE
***SUPPLEMENTAL VETERINARY NADAs***
138-995 MGA 100/200 PREMIX CATTLE UPJOHN MELENGESTROL ACETATE
13-JAN-95 TYLAN KALAMAZOO, MI 0.0000276-0.00022%
(PREMIX) 49001 TYLOSIN PHOSPHATE
90-360GM/TON
111-636 LINCOMIX CHICKENS, UPJOHN LINCOMYCIN
02-FEB-95 SOLUBLE POWDER SWINE KALAMAZOO, MI HYDROCHLORIDE
(PREMIX) 49001 80GM/PACKET
Date created: August 6, 1996; last updated: June 20, 2005 |
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