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Drug and Device Approvals-December 1995 December 1995 - FDA Drug and Device Product Approvals
***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-628 INVIRASE ROCHE SAQUINAVIR MESYLATE
06-DEC-95 (CAPSULE) NUTLEY, NJ EQ 200MG BASE
(1 P, AA*, E**, H***) 07110 (ANTIVIRAL)
[TREATMENT OF ADVANCED HIV
INFECTION IN SELECTED
PATIENTS IN COMBINATION
WITH NUCLEOSIDE ANALOGUES]
19-835 ZYRTEC PFIZER CETIRIZINE
HYDROCHLORIDE
08-DEC-95 (TABLET) NEW YORK, NY 5MG
(1 S) 10017 10MG
(H1-RECEPTOR
ANTAGONIST)
[SEASONAL AND
PERENNIAL
ALLERGIC RHINITIS,
CHRONIC URTICARIA]
20-221 ETHYOL US BIOSCIENCE AMIFOSTINE
08-DEC-95 (INJECTABLE) WEST CONSHOHOCKEN, PA 500MG/VIAL
(1 P, V****) 19428 (CYTOPROTECTIVE)
[TO REDUCE THE CUMULATIVE
RENAL TOXICITY ASSOCIATED
WITH REPEATED ADMINISTRATION
OF CISPLATIN IN PATIENTS
WITH ADVANCED OVARIAN CANCER]
AA* - Priority Classification AIDS Drug
E** - Drug for Severely Debilitating/Life Threatening Illness
H*** - Accelerated Approval (drug is intended to treat a serious of 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
20-363 FAMVIR SMITHKLINE BEECHAM FAMCICLOVIR
11-DEC-95 (TABLET) PHILADELPHIA, PA 125MG
(SUPPL-004) 19101 (NEW INDICATION --
TREATMENT OF ACUTE
RECURRENT GENITAL HERPES)
20-553 OXYCONTIN PURDUE FREDERICK OXYCODONE HYDROCHLORIDE
12-DEC-95 (TABLET, NORWALK, CT 10MG
(3 S) EXTENDED RELEASE) 06850 20MG
40MG
(OPIOID ANALGESIC)
20-599 RILUTEK RHONE POULENC RILUZOLE
12-DEC-95 (TABLET) COLLEGEVILLE, PA 50MG
(1P, V****) 19426 (NEUROPROTECTIVE)
[TREATMENT OF PATIENTS
WITH AMYOTROPHIC LATERAL
SCLEROSIS (ALS)]
19-785 CARDIOLITE DUPONT TECHNETIUM TC-99M
14-DEC-95 (INJECTABLE) WILMINGTON, DE SESTAMIBI KIT
(SUPPL-004) 19880 N/A
(NEW INDICATION --
LOCALIZE MYOCARDIAL ISCHEMIA
(REVERSIBLE DEFECTS) AND
INFARCTION (NON-REVERSIBLE
DEFECTS), IN EVALUATING
MYOCARDIAL FUNCTION)
19-785 CARDIOLITE DUPONT TECHNETIUM TC-99M
14-DEC-95 (INJECTABLE) WILMINGTON, DE SESTAMIBI KIT
(SUPPL-005) 19880 N/A
(NEW INDICATION --
LOCALIZE MYOCARDIAL ISCHEMIA
(REVERSIBLE DEFECTS) AND
INFARCTION (NON-REVERSIBLE
DEFECTS), IN EVALUATING
MYOCARDIAL FUNCTION)
V**** - Designated Orphan Drug
20-550 VALTREX GLAXO WELLCOME VALACYCLOVIR HYDROCHLORIDE
15-DEC-95 (TABLET) RES TRIANGLE PK, NC EQ 500MG BASE
(6 S) 27709 EQ 1GM BASE*
(ANTIVIRAL)
[EPISODIC TREATMENT OF
RECURRENT GENITAL HERPES
IN IMMUNOCOMPETENT ADULTS]
20-551 NIMBEX GLAXO WELLCOME CISATRACURIUM BESYLATE
15-DEC-95 (INJECTABLE) RES TRIANGLE PK, NC EQ 2MG BASE/ML
(2 S) 27709 (NONDEPOLARIZING SKELETAL
MUSCLE RELAXANT)
[ADJUNCT TO GENERAL
ANESTHESIA, TO FACILITATE
TRACHEAL INTUBATION, AND
PROVIDE SKELETAL MUSCLE
RELAXATION DURING SURGERY
OR MECHANICAL VENTILATION
IN THE ICU]
20-551 NIMBEX GLAXO WELLCOME CISATRACURIUM BESYLATE
15-DEC-95 PRESERVATIVE FREE RES TRIANGLE PK, NC EQ 2MG BASE/ML
(INJECTABLE) 27709 EQ 10MG BASE/ML
(NONDEPOLARIZING SKELETAL
MUSCLE RELAXANT)
[ADJUNCT TO GENERAL
ANESTHESIA, TO FACILITATE
TRACHEAL INTUBATION, AND
TO PROVIDE SKELETAL MUSCLE
RELAXATION DURING SURGERY
OR MECHANICAL VENTILATION
IN THE ICU]
20-515 ZOLADEX ZENECA GOSERELIN ACETATE
18-DEC-95 (IMPLANT) WILMINGTON, DE EQ 3.6MG BASE
(6 S) 19850 (LUTEINIZING HORMONE-
RELEASING HORMONE ANALOG)
[PALLIATIVE TREATMENT OF
ADVANCED BREAST CANCER IN
PRE- AND PERIMENOPAUSAL
WOMEN]
* - Not Marketed at This Time
20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE
19-DEC-95 (TABLET) RES TRIANGLE PK, NC 200MG*
(3 S) 27709 (ANTIVIRAL)
20-520 ZANTAC 75 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE
19-DEC-95 (TABLET) RES TRIANGLE PK, NC EQ 75MG BASE
(3 S) 27709 (HISTAMINE H-2 RECEPTOR
ANTAGONIST)
(OTC)
50-685 CEDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE
20-DEC-95 (CAPSULE) KENILWORTH, NJ EQ 400MG BASE
(1 S) 07033 (CEPHALOSPORIN)
50-686 EDAX SCHERING PLOUGH CEFTIBUTEN DIHYDRATE
20-DEC-95 (POWDER KENILWORTH, NJ EQ 90MG BASE/5ML
(3 S) FOR RECONSTITUTION) 07033 EQ 180MG BASE/5ML
(CEPHALOSPORIN)
20-316 OXILAN-300 COOK IMAGING IOXILAN
21-DEC-95 (INJECTABLE) BLOOMINGTON, IN 62%
(1 S) 47402 (DIAGNOSTIC RADIOPAQUE)
20-316 OXILAN-350 COOK IMAGING IOXILAN
21-DEC-95 (INJECTABLE) BLOOMINGTON, IN 73%
(1 S) 47402 (DIAGNOSTIC RADIOPAQUE)
20-412 ZERIT BRISTOL MYERS SQUIBB STAVUDINE
21-DEC-95 (CAPSULE) WALLINGFORD, CT 15MG
(SUPPL-002) 06492 20MG
30MG
40MG
(NEW INDICATION --
TREATMENT OF HIV-INFECTED
ADULTS WHO HAVE RECEIVED
PRIOR ZIDOVUDINE THERAPY)
20-421 FEMSTAT 3 SYNTEX BUTOCONAZOLE NITRATE
21-DEC-95 (CREAM) PALO ALTO, CA 2%
(3 S) 94303 (ANTIFUNGAL)
[TREATMENT OF VAGINAL
YEAST (CANDIDA) INFECTION]
(OTC)
* - Not Marketed at This Time
20-530 IONTOCAINE IOMED EPINEPHRINE
21-DEC-95 (SOLUTION) SALT LAKE CITY, UT 0.01MG/ML
(6 S) 84119 LIDOCAINE HYDROCHLORIDE
2%
(DERMAL ANESTHETIC)
[PRODUCTION OF LOCAL DERMAL
ANALGESIA BY IONTOPHORESIS]
20-517 LUPRON DEPOT TAP HOLDINGS LEUPROLIDE ACETATE
22-DEC-95 (INJECTABLE) DEERFIELD, IL 22.5MG/VIAL
(3 S) 60015 (GONADOTROPIN RELEASING
HORMONE ANALOG)
[PALLIATIVE TREATMENT OF
ADVANCED PROSTATIC CANCER]
20-451 PHOTOFRIN QLT PORFIMER SODIUM
27-DEC-95 (INJECTABLE) SEATTLE, WA 75MG/VIAL
(1 P, V****) 98101 (PHOTOSENSITIZER)
[PALLIATION OF PATIENTS
WITH COMPLETELY OR PARTIALLY
OBSTRUCTING ESOPHAGEAL
CANCER WHO CANNOT BE
SATISFACTORILY TREATED WITH
ND:YAG LASER THERAPY]
20-541 ARIMIDEX ZENECA ANASTROZOLE
27-DEC-95 (TABLET) WILMINGTON, DE 1MG
(1 S) 19850 (NON-STEROIDAL AROMATASE
INHIBITOR)
[TREATMENT OF ADVANCED
BREAST CANCER IN
POSTMENOPAUSAL WOMEN
WITH DISEASE PROGRESSION
FOLLOWING TAMOXIFEN
THERAPY]
20-491 CORVERT UPJOHN IBUTILIDE FUMARATE
28-DEC-95 (INJECTABLE) KALAMAZOO, MI 0.1MG/ML
(1 S) 49001 (ANTIARRHYTHMIC)
[TREATMENT OF ATRIAL
FIBRILLATION OR FLUTTER]
V**** - Designated Orphan Drug
20-386 COZAAR MERCK LOSARTAN POTASSIUM
29-DEC-95 (TABLET) WEST POINT, PA 25MG
(SUPPL-001) 19486 50MG
(COMPARATIVE EFFICACY
CLAIM - COMPARISON OF
COUGH SEEN IN PATIENTS
TREATED WITH LOSARTAN
VS. LISINOPRIL)
20-522 NUTROPIN AQ GENENTECH SOMATROPIN, BIOSYNTHETIC
29-DEC-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/ML
(3 S) 94080 (HUMAN GROWTH HORMONE)
***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.
20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE
14-DEC-95 (TABLET, ANN ARBOR, MI 500MG
EXTENDED RELEASE) 48106 1000MG
(ANTIARRHYTHMIC)
20-518 RETROVIR GLAXO WELLCOME ZIDOVUDINE
19-DEC-95 (TABLET) RES TRIANGLE PK, NC 300MG
27709 (ANTIVIRAL)
20-535 BROMFENAC SODIUM WYETH AYERST BROMFENAC SODIUM
28-DEC-95 (CAPSULE) RADNOR, PA EQ 25MG BASE
19087 EQ 50MG BASE
(NONSTEROIDAL
ANTI-INFLAMMATORY)
20-114 ASTELIN WALLACE AZELASTINE HYDROCHLORIDE
29-DEC-95 (SPRAY, METERED) PRINCETON, NJ EQ 0.125MG BASE/INH
08540 (ANTIHISTAMINE)
20-505 TOPAMAX JOHNSON RW TOPIRAMATE
29-DEC-95 (TABLET) RARITAN, NJ 25MG
08869 50MG
100MG
200MG
300MG
(ANTIEPILEPTIC)
19-821 SORIATANE ROCHE ACITRETIN
30-DEC-95 (CAPSULE) NUTLEY, NJ 10MG
07110 25MG
(RETINOID)
***ORIGINAL ABBREVIATED NDAs***
72-641 CLOTRIMAZOLE TARO CLOTRIMAZOLE
04-DEC-95 (CREAM) BRAMALEA, ONTARIO 1%
CANADA (ANTIFUNGAL)
(OTC)
74-222* EMBELINE DPT CLOBETASOL PROPIONATE
06-DEC-95 (SOLUTION) SAN ANTONIO, TX 0.05%
78215 (CORTICOSTEROID)
62-798 OXACILLIN SODIUM IBI OXACILLIN SODIUM
11-DEC-95 (INJECTABLE) APRILIA, ITALY EQ 125MG BASE/VIAL
EQ 250MG BASE/VIAL
EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
(ANTIBIOTIC, PENICILLIN)
63-167 AMIKACIN SULFATE ASTRA AMIKACIN SULFATE
14-DEC-95 (INJECTABLE) WESTBOROUGH, MA EQ 50MG BASE/ML
01581 (ANTIBIOTIC, AMINOGLYCOSIDE)
63-169 AMIKACIN SULFATE ASTRA AMIKACIN SULFATE
14-DEC-95 (INJECTABLE) WESTBOROUGH, MA EQ 250MG BASE/ML
01581 (ANTIBIOTIC, AMINOGLYCOSIDE)
72-708 MINOXIDIL MUTUAL PHARM MINOXIDIL
14-DEC-95 (TABLET) PHILADELPHIA, PA 2.5MG
19124 (ANTIHYPERTENSIVE)
72-709 MINOXIDIL MUTUAL PHARM MINOXIDIL
14-DEC-95 (TABLET) PHILADELPHIA, PA 10MG
19124 (ANTIHYPERTENSIVE)
74-331 CLOBETASOL NMC CLOBETASOL PROPIONATE
15-DEC-95 PROPIONATE BALTIMORE, MD 0.05%
(SOLUTION) 21224 (CORTICOSTEROID)
* - First Time Product Available Generically
74-406* SUFENTANIL CITRATE STERIS SUFENTANIL CITRATE
15-DEC-95 (INJECTABLE) PHOENIX, AZ EQ 0.05MG BASE/ML
85043 (NARCOTIC ANALGESIC)
74-413* SUFENTANIL CITRATE ELKINS SINN SUFENTANIL CITRATE
15-DEC-95 (INJECTABLE) CHERRY HILL, NJ EQ 0.05MG BASE/ML
08003 (NARCOTIC ANALGESIC)
74-522 CHLORHEXIDINE LEMMON CHLORHEXIDINE GLUCONATE
15-DEC-95 GLUCONATE SELLERSVILLE, PA 0.12%
SOLUTION) 18960 (ANTIMICROBIAL)
74-525 IBUPROFEN INVAMED IBUPROFEN
15-DEC-95 (TABLET) DAYTON, NJ 200MG
[BROWN] 08810 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
74-533 IBUPROFEN INVAMED IBUPROFEN
15-DEC-95 (TABLET) DAYTON, NJ 200MG
[WHITE] 08810 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
73-617 PENTAMIDINE ELKINS SINN PENTAMIDINE ISETHIONATE
18-DEC-95 ISETHIONATE CHERRY HILL, NJ 300MG/VIAL
(INJECTABLE) 08003 (ANTIPROTOZOAL)
73-138 TRAZODONE HCL MUTUAL PHARM TRAZODONE HYDROCHLORIDE
22-DEC-95 (TABLET) PHILADELPHIA, PA 150MG
19124 (ANTIDEPRESSANT)
72-750 METOCLOPRAMIDE HCL SIDMAK LABS NJ METOCLOPRAMIDE HYDROCHLORIDE
28-DEC-95 (TABLET) EAST HANOVER, NJ EQ 5MG BASE
07936 (UPPER GI TRACT
MOTILITY STIMULATOR)
* - First Time Product Available Generically
73-272* ALBUTEROL NORTON WATERFORD ALBUTEROL
28-DEC-95 (AEROSOL, METERED) WATERFORD, IRELAND 0.09MG/INH
(BETA-2 AGONIST)
74-291 CHLORHEXIDINE BARRE CHLORHEXIDINE GLUCONATE
28-DEC-95 GLUCONATE BALTIMORE, MD 0.12%
(SOLUTION) 21224 (ANTIMICROBIAL)
64-053 NEOMYCIN AND BAUSCH AND LOMB HYDROCORTISONE
29-DEC-95 POLYMYXIN B SULFATES TAMPA, FL 1%
AND HYDROCORTISONE 33637 (CORTICOSTEROID)
(SOLUTION/DROPS) NEOMYCIN SULFATE
EQ 3.5MG BASE/ML
(ANTIBIOTIC, AMINOGLYCOSIDE)
POLYMYXIN B SULFATE
10,000 UNITS/ML
(ANTIBIOTIC, PEPTIDE)
74-024 KETOPROFEN GENEVA PHARMS KETOPROFEN
29-DEC-95 (CAPSULE) BROOMFIELD, CO 50MG
80038 75MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-112 ALPRAZOLAM GENEVA PHARMS ALPRAZOLAM
29-DEC-95 (TABLET) BROOMFIELD, CO 0.25MG
80038 0.5MG
1MG
(ANXIOLYTIC)
74-449 SULFACETAMIDE SODIUM BAUSCH AND LOMB PREDNISOLONE SODIUM
29-DEC-95 AND PREDNISOLONE TAMPA, FL PHOSPHATE
SODIUM PHOSPHATE 33637 EQ 0.23% PHOSPHATE
SOLUTION/DROPS) (CORTICOSTEROID)
SULFACETAMIDE SODIUM
10%
(ANTIBACTERIAL)
* - 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.
74-589 MINOXIDIL LEMMON MINOXIDIL
15-DEC-95 (SOLUTION) SELLERSVILLE, PA 2%
18960 (HAIR GROWTH STIMULATOR)
74-643 MINOXIDIL BAUSCH AND LOMB MINOXIDIL
22-DEC-95 (SOLUTION) TAMPA, FL 2%
33637 (HAIR GROWTH STIMULATOR)
74-418 CAPTOPRIL ENDO CAPTOPRIL
28-DEC-95 (TABLET) GARDEN CITY, NY 12.5MG
11530 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
19-787 NORVASC PFIZER AMLODIPINE BESYLATE
05-DEC-95 (TABLET) NEW YORK, NY EQ 2.5MG BASE
10017 EQ 5MG BASE
EQ 10MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
20-356 SULAR ZENECA NISOLDIPINE
05-DEC-95 (TABLET, WILMINGTON, DE 10MG
EXTENDED RELEASE) 19850 20MG
30MG
40MG
(LABELING REVISION --
NEW TRADE NAME;
HOW SUPPLIED)
50-512 DURICEF BRISTOL MYERS SQUIBB CEFADROXIL
05-DEC-95 (CAPSULE) PRINCETON, NJ EQ 500MG BASE
08543 (LABELING REVISION --
INDICATIONS AND USAGE)
50-527 DURICEF BRISTOL MYERS SQUIBB CEFADROXIL
05-DEC-95 (POWDER PRINCETON, NJ EQ 125MG BASE/5ML
FOR RECONSTITUTION) 08543 EQ 250MG BASE/5ML
EQ 500MG BASE/5ML
(LABELING REVISION --
INDICATIONS AND USAGE)
50-528 DURICEF BRISTOL MYERS SQUIBB CEFADROXIL
05-DEC-95 (TABLET) PRINCETON, NJ EQ 1GM BASE
08543 (LABELING REVISION --
INDICATIONS AND USAGE)
19-081 ESTRADERM CIBA ESTRADIOL
07-DEC-95 (FILM, SUMMIT, NJ 0.05MG/24HR
EXTENDED RELEASE) 07901 0.1MG/24HR
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
HOW SUPPLIED;
PATIENT PACKAGE INSERT)
19-886 SYNAREL SEARLE NAFARELIN ACETATE
07-DEC-95 (SPRAY, METERED) SKOKIE, IL EQ 0.2MG BASE/INH
60077 (LABELING REVISION --
ADVERSE REACTIONS)
20-323 VIVELLE CIBA GEIGY ESTRADIOL
07-DEC-95 (FILM, SUMMIT, NJ 0.0375MG/24HR
EXTENDED RELEASE) 07901 0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INFORMATION FOR PATIENT;
HOW SUPPLIED;
PATIENT PACKAGE INSERT)
19-258 CIDA-STAT HUNTINGTON LABS CHLORHEXIDINE GLUCONATE
08-DEC-95 (SOLUTION) HUNTINGTON, IN 2%
46750 (LABELING REVISION --
FDA STANDARD WARNINGS FOR
CHLORHEXIDINE GLUCONATE
PRODUCTS)
(OTC)
19-258 CHG SCRUB HUNTINGTON LABS CHLORHEXIDINE GLUCONATE
08-DEC-95 (SOLUTION) HUNTINGTON, IN 4%
46750 (LABELING REVISION --
FDA STANDARD WARNINGS FOR
CHLORHEXIDINE GLUCONATE
PRODUCTS)
(OTC)
14-134 PROTOPAM CHLORIDE WYETH AYERST PRALIDOXIME CHLORIDE
11-DEC-95 (INJECTABLE) PHILADELPHIA, PA 1GM/VIAL
19101 (LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
20-210 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE
11-DEC-95 (TABLET) PISCATAWAY, NJ EQ 10MG BASE
08855 EQ 20MG BASE
(LABELING REVISION --
PRECAUTIONS)
20-323 VIVELLE CIBA GEIGY ESTRADIOL
11-DEC-95 (FILM, SUMMIT, NJ 0.0375MG/24HR
EXTENDED RELEASE) 07901 0.05MG/24HR
0.075MG/24HR
0.1MG/24HR
(LABELING REVISION --
HOW SUPPLIED;
PATIENT PACKAGE INSERT)
20-363 FAMVIR SMITHKLINE BEECHAM FAMCICLOVIR
11-DEC-95 (TABLET) PHILADELPHIA, PA 125MG
19101 500MG
(LABELING REVISION --
DESCRIPTION;
INDICATIONS AND USAGE;
HOW SUPPLIED)
20-398 PROPULSID JANSSEN CISAPRIDE MONOHYDRATE
11-DEC-95 (SUSPENSION) TITUSVILLE, NJ EQ 1MG BASE/ML
08560 (LABELING REVISION --
PRECAUTIONS)
19-943 LUPRON DEPOT TAP HOLDINGS LEUPROLIDE ACETATE
12-DEC-95 (INJECTABLE) DEERFIELD, IL 3.75MG/VIAL
60015 (LABELING REVISION --
PATIENT PACKAGE INSERT)
20-068 FOSCAVIR ASTRA FOSCARNET SODIUM
12-DEC-95 (INJECTABLE) WESTBOROUGH, MA 24MG/ML
01581 (LABELING REVISION --
CLINICAL TRIALS)
19-785 CARDIOLITE DUPONT TECHNETIUM TC-99M
14-DEC-95 (INJECTABLE) WILMINGTON, DE SESTAMIBI KIT
19880 N/A
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS)
50-560 CEFIZOX FUJISAWA CEFTIZOXIME SODIUM
14-DEC-95 (INJECTABLE) MELROSE PARK, IL EQ 500MG BASE/VIAL
60160 EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
50-672 CEFTIN GLAXO WELLCOME CEFUROXIME AXETIL
14-DEC-95 (POWDER RES TRIANGLE PK, NC EQ 125MG BASE/5ML
FOR RECONSTITUTION) 27709 (LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
12-122 GLUCAGON LILLY GLUCAGON HYDROCHLORIDE
15-DEC-95 (INJECTABLE) INDIANAPOLIS, IN EQ 1MG BASE/VIAL
46285 (LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
10-187 RITALIN CIBA METHYLPHENIDATE
15-DEC-95 (TABLET) SUMMIT, NJ HYDROCHLORIDE
07901 5MG
10MG
20MG
(LABELING REVISION --
PRECAUTIONS)
18-029 RITALIN-SR CIBA METHYLPHENIDATE
15-DEC-95 (TABLET, SUMMIT, NJ HYDROCHLORIDE
EXTENDED RELEASE) 07901 20MG
(LABELING REVISION --
PRECAUTIONS)
18-537 TRIDIL FAULDING NITROGLYCERIN
15-DEC-95 (INJECTABLE) ELIZABETH, NJ 0.5MG/ML
07207 5MG/ML
(LABELING REVISION --
PRECAUTIONS)
18-470 CIBACALCIN CIBA CALCITONIN, HUMAN
18-DEC-95 (INJECTABLE) SUMMIT, NJ 0.5MG/VIAL
07901 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-726 ZOLADEX ZENECA GOSERELIN ACETATE
18-DEC-95 (IMPLANT) WILMINGTON, DE EQ 3.6MG BASE
19850 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
12-141 CYTOXAN BRISTOL CYCLOPHOSPHAMIDE
20-DEC-95 (TABLET) SYRACUSE, NY 25MG
13221 50MG
(LABELING REVISION --
WARNINGS; ADVERSE REACTIONS;
HOW SUPPLIED)
12-142 CYTOXAN BRISTOL CYCLOPHOSPHAMIDE
20-DEC-95 (INJECTABLE) SYRACUSE, NY 100MG/VIAL
13221 200MG/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
(LABELING REVISION --
WARNINGS; ADVERSE REACTIONS;
HOW SUPPLIED)
12-142 LYOPHILIZED CYTOXAN BRISTOL CYCLOPHOSPHAMIDE
20-DEC-95 (INJECTABLE) SYRACUSE, NY 100MG/VIAL
13221 200MG/VIAL
500MG/VIAL
1GM/VIAL
2GM/VIAL
(LABELING REVISION --
WARNINGS; ADVERSE REACTIONS;
HOW SUPPLIED)
50-441 CLEOCIN PHOSPHATE UPJOHN CLINDAMYCIN PHOSPHATE
20-DEC-95 (INJECTABLE) KALAMAZOO, MI EQ 150MG BASE/ML
49001 (LABELING REVISION --
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
50-639 CLEOCIN PHOSPHATE UPJOHN CLINDAMYCIN PHOSPHATE
20-DEC-95 IN DEXTROSE 5% KALAMAZOO, MI EQ 6MG BASE/ML
IN PLASTIC CONTAINER 49001 EQ 12MG BASE/ML
(INJECTABLE) EQ 18MG BASE/ML
(LABELING REVISION --
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
20-412 ZERIT BRISTOL MYERS SQUIBB STAVUDINE
21-DEC-95 (CAPSULE) WALLINGFORD, CT 15MG
06492 20MG
30MG
40MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
19-684 PROCARDIA XL PFIZER NIFEDIPINE
26-DEC-95 (TABLET, NEW YORK, NY 30MG
EXTENDED RELEASE) 10017 60MG
90MG
(LABELING REVISION --
PRECAUTIONS)
50-664 CEFZIL BRISTOL MYERS SQUIBB CEFPROZIL
26-DEC-95 (TABLET) WALLINGFORD, CT 250MG
06492 500MG
(LABELING REVISION --
WARNINGS)
50-665 CEFZIL BRISTOL MYERS SQUIBB CEFPROZIL
26-DEC-95 (POWDER WALLINGFORD, CT 125MG/5ML
FOR RECONSTITUTION) 06492 250MG/5ML
(LABELING REVISION --
WARNINGS)
20-386 COZAAR MERCK LOSARTAN POTASSIUM
29-DEC-95 (TABLET) WEST POINT, PA 25MG
19486 50MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
0230 NONE NORTHERN CALIFORNIA PLATELETS
06-DEC-95 (INJECTABLE) COMM BLOOD BANK (B)
EUREKA, CA
95501
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950029 CAPTURE CMV IMMUCOR CYTOMEGALOVIRUS
22-DEC-95 NORCROSS, GA ANTIBODY SCREEN
30091 (C)
BK950046 ABBOTT CMV ABBOTT CMV TOTAL AB EIA
22-DEC-95 TOTAL AB EIA ABBOTT PARK, IL (C)
60064
BK950068 CMV SCAN BECTON DICKINSON PASSIVE LATEX AGGLUTINATIVE
22-DEC-95 CARD TEST COCKEYSVILLE, MD TEST FOR DETECTION OF
21030 ANTIBODIES TO CMV
(C)
(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
P870072 THORATEC ADVANCED BIORESEARCH INTENDED AS A BRIDGE
12/20/95 VENTRICULAR ASSOCIATES TO CARDIAC
ASSIST DEVICE ROCKVILLE, MD TRANSPLANTATION FOR
(VAD) SYSTEM 20852-1631 USE IN PATIENTS
SUFFERING FROM
END-STAGE HEART
FAILURE
P940010 OPTIGUIDE QLT PHOTOTHERAPEUTICS, APPROVAL FOR
12/27/95 FIBER OPTIC INC. OPTIGUIDE FIBER OPTIC
DIFFUSER, SEATTLE, WA DIFFUSER, MODELS DCYL
MODELS DCYL 10, 98101 10, DCYL 15, AND
DCYL 15, AND DCYL 25 FOR USE WITH
DCYL 25 PHOTOFRIN FOR PALLIATION
OF ESOPHAGEAL CANCER
P940011 COHERENT PDL1 QLT PHOTOTHERAPEUTICS, COHERENT PDL1 AND
12/27/95 AND PDL2 LAMBDA INC. PDL2 LAMBDA PLUS
PLUS SEATTLE, WA PHOTODYNAMIC LASERS
PHOTODYNAMIC 98101 FOR USE WITH
LASERS PHOTOFRIN FOR PALLIATION
OF ESOPHAGEAL CANCER
P940012 600 SERIES DYE QLT PHOTOTHERAPEUTICS, 600 SERIES DYE
12/27/95 MODULES (MODELS INC. MODULES (MODELS 630
630 AND 630 XP) SEATTLE, WA AND 630XP) AND SERIES
AND SERIES 700 98101 700 AND 800 KTP/532
AND 800 KTP/532 AND KTP/YAG
AND KTP/YAG (OPERATING AT 532NM)
SURGICAL LASERS SURGICAL LASERS FOR
USE WITH PHOTOFRIN
P940034 GEN-PROBE GEN-PROBE INC. FOR USE AS AN
12/15/95 AMPLIFIED SAN DIEGO, CA ADJUNCTIVE TEST FOR
MYCOBACTERIUM 92121 EVALUATING AFB SMEAR
TUBERCULOSIS POSITIVE CONCENTRATED
DIRECT TEST SEDIMENTS FROM
UNTREATED PATIENTS
SUSPECTED OF HAVING TB
P950021 TECHNICON IMMUNO BAYER CORPORATION APPROVAL FOR THE
12/22/95 1 PSA ASSAY TARRYTOWN, NY TECHNICON IMMUNO 1
10591 PSA ASSAY - THIS
DEVICE IS AN IN VITRO
DIAGNOSTIC DEVICE
***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
N17600/S013 AVITENE MEDCHEM ALTERNATIVE FINISHED
12/27/95 MICROFIBRILLAR PRODUCTS, INC. DEVICE FACILITY AT
COLLAGEN HEMOSTAT WOBURN, MA WOBURN, MA 01801
(MCH) 01801
P790018/S026 MEDTRONIC HALL MEDTRONIC, INC. APPROVAL FOR 100%
12/07/95 PROSTHETIC HEART MINNEAPOLIS, MN ETO STERILIZATION
VALVE 55440
P800049/S007 IRIDOCAPSULAR ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 INTRAOCULAR LENS INC. ALTERNATE STERILIZATION
FORT WORTH, TX PROCESS INCLUDING
76134-2099 AERATION TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P810001/S012 ANTERIOR CHAMBER ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 INTRAOCULAR LENS INC. ALTERNATE STERILIZATION
FORT WORTH, TX PROCESS INCLUDING
76134-2099 AERATION TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P810018/S035 UV ABSORBING ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 POSTERIOR CHAMBER INC. ALTERNATE STERILIZATION
INTRAOCULAR LENS FORT WORTH, TX PROCESS INCLUDING
76134-2099 AERATION TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P810032/S048 UV ABSORBING ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 POSTERIOR CHAMBER INC. ALTERNATE STERILIZATION
INTRAOCULAR LENS FORT WORTH, TX PROCESS INCLUDING
76134-2099 AERATION TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P810046/S157 ACS SIMPSON-ROBERT ADVANCED APPROVAL FOR THE ACS
12/05/95 CORONARY DILATATION CARDIOVASCULAR OTW LIFESTREAM CORONARY
CATHETER SANTA CLARA, CA DILATATION CATHETER
95052-8167
P810046/S160 SIMPSON-ROBERT ADVANCED MODIFICATIONS OF THE
12/28/95 PTCA CATHETER CARDIOVASCULAR INFLATION/DEFLATION
ACS RX LIFESTREAM TEMECULA, CA NOTCH AND CHANGES TO
AND ACS OTW 92591-4628 THE GUIDE WIRE EXIT
LIFESTREAM PTCA NOTCH AND PROXIMAL
CATHETERS ADAPTION VISUAL
INSPECTION CRITERIA
P820001/S018 OPTI-FREE ALCON LABORATORIES, APPROVAL FOR A
12/28/95 SUPRA-CLENS DAILY INC. PANCREATIN-BASED
PROTEIN REMOVER FORT WORTH, TX LIQUID ENZYMATIC CLEANER
76134-2099
P820021/S025 NEWVUES, NEWVUES CIBA VISION, ALTERNATE MANUFACTURING
12/13/95 SOFTCOLORS, CORPORATION SITE TO MAKE SOFT
FOCUS, FOCUS DULUTH, GA CONTACT LENS BLANKS
VISITINT, AND 30136-1518
FOCUS SOFTCOLORS
(VIFILCON A)
SOFT (HYDROPHILIC)
CONTACT LENSES
P820035/S014 ANTERIOR CHAMBER ALCON LABORATORIES, APPROVAL FOR AN ALTERNATE
12/13/95 INTRAOCULAR LENS INC. STERILIZATION PROCESS
FORT WORTH, TX INCLUDING AERATION TIME
76134-2099 AND THE ESTABLISHMENT
OF THE BIOLOGICAL INDICATOR
INCUBATION TIME
P820040/S033 AOSEPT CIBA VISION, APPROVAL FOR LABELING
12/13/95 DISINFECTANT CORPORATION MODIFICATIONS IN THE
DULUTH, GA PACKAGE INSERT
30136-1518
P820060/S009 ABBOTT AXSYM AFP ABBOTT LABORATORIES MODIFICATION OF THE
12/26/95 ABBOTT PARK, IL POTENCY TEST FOR THE
60064-3500 ANTI-AFP: ALKALINE
PHOSPHATASE CONJUGATE
P820076/S020 BIOTRONIK GEMNOS BIOTRONIK, INC. APPROVAL FOR THE CHANGE
12/22/95 AND GEMNOS 04, LAKE OSWEGO, OR IN THE BURN-IN PROCESSING
O4A, AND TC 04 97035-5369 OF THE WILSON GREATBATCH
BATTERIES REDUCTION OF
BATTERY BURN-IN TIME FROM
35 DAYS TO 4 DAYS
P830040/S025 3M VISION CARE ALCON LABORATORIES, APPROVAL FOR AN ALTERNATE
12/13/95 POSTERIOR CHAMBER INC. STERILIZATION PROCESS
INTRAOCULAR LENS FT. WORTH, TX INCLUDING AERATION TIME
76134-2099 AND THE ESTABLISHMENT
OF THE BIOLOGICAL INDICATOR
INCUBATION TIME
P830055/S042 NEW JERSEY LCS DEPUY, INC. APPROVAL OF MINIMUM
12/13/95 TOTAL KNEE SYSTEM WARSAW, IN DOSE GAMMA IRRADIATION
46581-0988 VALIDATION FOR
POLYETHYLENE COMPONENTS
P830055/S044 ROTATING PLATFORM DEPUY, INC. APPROVAL FOR THE ADDITION
12/28/95 CONFIGURATION OF WARSAW, IN OF SMALL AND SMALL+ SIZED
THE NEW JERSEY LCS 46581-0988 BEARING COMPONENTS
TOTAL KNEE SYSTEM
P840001/S038 MODEL 7495, MEDTRONIC APPROVAL FOR THE USE OF
12/06/95 ITREL II NEUROLOGICAL SEALING RINGS IN THE
PERMANENT EXTENSION MINNEAPOLIS, MN MODEL 7495 PERMANENT
55440-9087 EXTENSION
P840024/S059 NUCLEUS 22 COCHLEAR CORPORATION CHANGES TO THE INTEGRATED
12/11/95 CHANNEL COCHLEAR ENGLEWOOD, CO CIRCUIT (IC) TEST SOFTWARE
IMPLANT SYSTEM 80112 (K15001) IN ORDER TO ADD
SEVERAL TESTS OF IMPROVED
QUALITY ASSURANCE
P840060/S024 POSTERIOR CHAMBER ALCON LABORATORIES, APPROVAL FOR AN ALTERNATE
12/13/95 INTRAOCULAR LENS INC. STERILIZATION PROCESS
FORT WORTH, TX INCLUDING AERATION TIME
76134-2099 AND THE ESTABLISHMENT OF
THE BIOLOGICAL INDICATOR
INCUBATION TIME
P850064/S011 MODEL 203 LIFE BUNNELL, INC. ADDITION OF AN
12/18/95 PULSE HIGH SALT LAKE CITY, UT ENDOTRACHEAL TUBE
FREQUENCY JET 84115 ADAPTER - TRADE NAME:
VENTILATOR "LIFEPORT"
P850089/S033 CAPSURE Z MEDTRONIC, INC. NEW MODELS:
12/21/95 MODELS 5034/ MINNEAPOLIS, MN CAPSURE Z 5035,
5534/5033 55432-3576 5534, AND 5033
PACING LEADS PACING LEADS
P860019/S094 SCIMED PTCA SCIMED LIFE APPROVAL FOR A CHANGE
12/07/95 CATHETERS SYSTEMS, INC. IN STERILIZATION
MAPLE GROVE, MN PROCESS FROM 12/88
55311-1566 ETHYLENE OXIDE/CFC-12
TO 8.6/91.6 OXYFUME
2000 MIXTURE
P870036/S037 VERSAFLEX MEDTRONICS ALTERNATE ADHESIVE
12/07/95 BUCHBINDER INTERVENTIONAL FOR PTCA CATHETERS
OMNIFLEX PTCA SAN DIEGO, CA
CATHETER SYSTEM 92121-2256
MEDTRONIC 18K, 18K
WITH TIP MARKER,
14K, 14K LONG,
PANTHER,
PANTHER 30,
AND PANTHER 40
PTCA CATHETERS
P880003/S050 CORDIS PTCA CORDIS CORPORATION MODIFICATION OF THE
12/05/95 DILATATION CATHETER MIAMI, FL EXIT MARKER MATERIAL
CORDIS TITAN 18 33102-5700 AND APPLICATION PROCESS
PTCA DILATATION CATHETER
AND TITAN XL PTCA
DILATATION CATHETER
P880003/S051 CORDIS PTCA CORDIS CORPORATION ALTERNATE
12/06/95 DILATION CATHETERS MIAMI, FL STERILIZATION SITE
33102-5700 (ISOMEDIX)
NORTHBOROUGH,
MASSACHUSETTS
P880010/S018 POSTERIOR CHAMBER ALCON LABORATORIES APPROVAL FOR AN
12/13/95 INTRAOCULAR LENS FORT WORTH, TX ALTERNATE
76134-2099 STERILIZATION PROCESS
INCLUDING AERATION TIME
AND THE ESTABLISHMENT
OF THE BIOLOGICAL
INDICATOR INCUBATION
P880028/S003 DEXTRAN HM 32% ABBOTT LABORATORIES APPROVAL FOR DELETING
12/15/95 HYSTEROSCOPIC ABBOTT PARK, IL THE TEST FOR ANTIGENIC
DISTENTION MEDIUM 60064-3537 IMPURITIES IN THE TESTING
SPECIFICATIONS FOR THE
DEXTRAN 70 (CODE 59479)
BULK DRUG SUBSTANCE
P880087/S006 ANTERIOR CHAMBER ALCON LABORATORIES APPROVAL FOR AN ALTERNATE
12/13/95 INTRAOCULAR LENS FORT WORTH, TX STERILIZATION PROCESS
76134-2099 INCLUDING AERATION TIME
AND THE ESTABLISHMENT
OF THE BIOLOGICAL INDICATOR
INCUBATION TIME
P890003/S041 MEDTRONIC MEDTRONIC, INC. ALTERNATE STERILIZATION
12/06/95 SYNERGYST II MINNEAPOLIS, MN PROCESS
PULSE GENERATOR 55432-3576
SYSTEM
P890027/S028 NUCLEUS 22 COCHLEAR CORPORATION ADDITIONAL QUALITY
12/11/95 CHANNEL COCHLEAR ENGLEWOOD, CO ASSURANCE PROVISIONS
IMPLANT SYSTEM 80112 DURING TESTING OF THE
MINI 22 COCHLEAR IMPLANT
FOR THE NUCLEUS 22-CHANNEL
COCHLEAR IMPLANT SYSTEM
P890034/S005 MODEL 1010 INFRASONICS, INC. APPROVAL FOR A
12/28/95 ULTRAHIGH FREQUENCY SAN DIEGO, CA PROXIMAL MONITORING
VENTILATOR 92121-1402 ENDOTRACHEAL TUBE
ADAPTER FOR USE WITH
THE ADULT STAR
MODEL 1010 ULTRAHIGH
FREQUENCY VENTILATOR
P900052/S003 PORT-A-CATH SIMS DELTEC, INC. ADDITION OF A 16
12/21/95 INTRASPINAL ST PAUL, MN GAUGE, THIN-WALL
IMPLANTABLE 55112 INTRODUCER NEEDLE
ACCESS SYSTEM (MANAN EPIDURAL
NEEDLE (K852428)) TO
THE PORT-A-CATH
EPIDURAL IMPLANTABLE
P900061/S014 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR THE
12/06/95 MODEL 7219C/7202C MINNEAPOLIS, MN MEDTRONIC MODEL
JEWEL ACTIVE CAN 55432-3576 7219C/7202C JEWEL
MANAGEMENT SYSTEMS ACTIVE CAN ARRHYTHMIA
MANAGEMENT SYSTEMS
P900061/S020 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR MED REL,
12/14/95 7219B, 7219E, AND MINNEAPOLIS, MN ROAD 909, KM.0.4,
7202E ARRHYTHMIA 55432-3576 BARRIO MARIANA,
MANAGEMENT DEVICES HUMACAO, PUERTO RICO
00661 TO MANUFACTURE
THE MODELS 7219B,
7219E, AND 7202E
P910016/S005 UNICOMPARTMENTAL DEPUY INC. APPROVAL OF MINIMUM
12/13/95 DEVICE WARSAW, IN DOSE GAMMA IRRADIATION
CONFIGURATION OF 46581-0988 VALIDATION FOR
THE NEW JERSEY POLYETHYLENE COMPONENTS
LCS TOTAL KNEE
SYSTEM
P910016/S006 UNICOMPARTMENTAL DEPUY INC. APPROVAL OF ETHYLENE
12/13/95 DEVICE WARSAW, IN OXIDE STERILIZATION
CONFIGURATION OF 46581-0988 FOR POLYETHYLENE
THE NEW JERSEY COMPONENTS
LCS TOTAL KNEE
SYSTEM
P910023/S012 CADET V-105 "C" VENTRITEX, INC. APPROVAL FOR CADENCE
12/22/95 AND "D" AND V-115 SUNNYVALE, CA TIERED THERAPY
"C" AND "D" 94086-6527 DEFIBRILLATOR SYSTEM
PULSE GENERATORS, WITH "C" AND "D"
AND SOFTWARE HEADER STYLES
VERSION 4.1 FOR
THE PROGRAMMER
MODEL PR-1500
P910031/S003 CATHSCANNER ENDOSONICS CORP. APPROVAL FOR THE
12/07/95 ORACLE MICRO RANCHO CORDOVA, CA ENDOSONICS ORACLE
PTCA CATHETER 95670 FOCUS PTCA CATHETER,
AS MODIFIED WILL BE
MARKETED UNDER THE
TRADE NAME ENDOSONICS
ORACLE FOCUS PTCA CATHETER
P910058/S007 MODEL C11UB CHIRON VISION CORP. APPROVAL FOR MODEL C11UB
12/14/95 ULTRAVIOLET- CLAREMONT, CA ULTRAVIOLET-ABSORBING
ABSORBING SILICONE 91711 POSTERIOR CHAMBER
POSTERIOR CHAMBER INTRAOCULAR LENS
INTRAOCULAR LENS
P910075/S004 COMPLETE BRAND ALLERGAN OPTICAL APPROVAL FOR THE
12/05/95 LUBRICATING AND IRVINE, CA FOLLOWING ALTERNATE
REWETTING DROPS 92713-9534 MANUFACTURING
SITE: ALLERGAN AMERICA,
PUERTO RICO
ROAD 345 KM 1.5,
HORMIGUEROS, PUERTO
RICO, 00660
P910077/S008 VENTAK MINI GUIDANT CORPORATION APPROVAL FOR THE
12/21/95 AICD SYSTEM ST. PAUL, MN VENTAK MINI AICD
55112-5798 SYSTEM, WHICH
INCLUDES: MODEL NUMBERS
1645, 1740, 1741, 1745,
AND 1746 PULSE GENERATORS;
MODEL 2840 SOFTWARE
P920015/S008 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR USE OF
12/07/95 TRANSVENE LEAD MINNEAPOLIS, MN AN ALTERNATE
SYSTEM 55432-3576 STERILIZATION PROCESS
AND A MODIFICATION TO
THE DISTAL END OF THE
TRANSVENE LEADS
P920030/S001 CIBA CORNING ACS CIBA-CORNING CHANGE IN THE METHOD
12/13/95 PSA IMMUNOASSAY DIAGNOSTICS OF STANDARDIZATION
MEDFIELD, MA OF THE CALIBRATORS
02052-1688 FOR THE ASSAY
P920051/S001 STORZ MODULITH KARL STORZ APPROVAL FOR A MOBILE
12/19/95 LITHOTRIPTER LITHOTRIPSY-AMERICA, VERSION OF THE STORZ
MODEL SL20 CULVER CITY, CA MODULITH
90230-7600 LITHOTRIPTER, MODEL SL20
P920051/S002 STORZ MODULITH KARL STORZ INCLUSION OF AN UPGRADED
12/11/95 LITHOTRIPTER, LITHOTRIPSY-AMERICA, VIDEO MIXER AND A
SL20 KENNESAW, GA MODIFICATION OF THE
30144 WATER CIRCUIT TO
INCLUDE PRESSURE
***ORIGINAL VETERINARY NADAs***
THERE ARE NO ORIGINAL VETERINARY NADAs FOR DECEMBER 1995.
***ORIGINAL ABBREVIATED VETERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR DECEMBER 1995.
***SUPPLEMENTAL VETERINARY NADAs***
095-735 RUMENSIN CATTLE ELANCO ANIMAL HEALTH MONENSIN SODIUM
12-DEC-95 (PREMIX) DIV ELI LILLY 80GM/LB
INDIANAPOLIS, IN
46285
011-116 ZOAMIX CHICKENS, AL PHARMA ZOALENE
22-DEC-95 (PREMIX) TURKEYS FT LEE, NJ 25%
07024 TYPE A MEDICATED
ARTICLE
Date created: May 23, 1996; last updated: June 20, 2005 |
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