 |
 |
 |
|
 | |||||
| |||||||||
 | |||||||||
|
|
 |
|
|
Drug and Device Product Approvals for January 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
19-963 RENOVA RW JOHNSON TRETINOIN
29-DEC-95 (CREAM) RARITAN, NJ 0.05%
(3 S) 08869 (RETINOID)
20-353 NAPRELAN ELAN NAPROXEN SODIUM
05-JAN-96 (TABLET, GAINESVILLE, GA EQ 375MG BASE
(3 S) EXTENDED RELEASE) 30504 EQ 500MG BASE
EQ 750MG BASE
(NONSTEROIDAL
ANTI-INFLAMMATORY)
20-578 ZOLADEX ZENECA GOSERELIN ACETATE
11-JAN-96 (IMPLANT) WILMINGTON, DE EQ 10.8MG BASE
(3 S) 19850 (LUTEINIZING HORMONE - RELEASING HORMONE
ANALOG)
[PALLIATIVE TREATMENT OF
ADVANCED PROSTATIC
CANCER]
50-679 MAXIPIME BRISTOL MYERS SQUIBB CEFEPIME HYDROCHLORIDE
18-JAN-96 (INJECTABLE) WALLINGFORD, CT [ARGININE FORMULATION]
(1 S) 06492 EQ 500MG BASE/VIAL
EQ 1GM BASE/VIAL
EQ 2GM BASE/VIAL
(CEPHALOSPORIN)
20-485 OCUHIST AKORN NAPHAZOLINE HYDROCHLORIDE
31-JAN-96 (SOLUTION/DROPS) ABITA SPRINGS, LA 0.025%
(5 S) 70420 PHENIRAMINE MALEATE
0.3
%
(ANTIHISTAMINE/DECONGESTANT)
[TEMPORARY RELIEF OF
ITCHING AND REDNESS OF
THE EYE DUE TO POLLEN,
RAGWEED, GRASS, ANIMAL
HAIR AND DANDER]
(OTC)
20-545 PROCANBID PARKE DAVIS PROCAINAMIDE HYDROCHLORIDE
31-JAN-96 (TABLET, ANN ARBOR, MI 500MG
(3 S) EXTENDED RELEASE) 48106 1GM
(ANTIARRHYTHMIC)
***ERRATA***
19-785* CARDIOLITE DUPONT TECHNETIUM TC-99M
14-DEC-95 (INJECTABLE) WILMINGTON, DE SESTAMIBI KIT
(SUPPL-005) 19880
N/A
(INDICATION CLARIFICATION
--
USE OF CARDIOLITE IN
CONJUNCTION WITH
PHARMACOLOGIC STRESS
AGENTS TO DIAGNOSE AND
LOCALIZE CORONARY ARTERY
DISEASE)
20-515 NIMBEX GLAXO WELLCOME CISATRACURIUM BESYLATE
15-DEC-95 PRESERVATIVE FREE RES TRIANGLE PK, NC EQ 2MG BASE/ML
(2 S)** (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]
* - Indication previously published from wrong supplement number
** - Classification code previously omitted
***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.
20-454 ZANTAC 150 GLAXO WELLCOME RANITIDINE HYDROCHLORIDE
02-JAN-96 (TABLET, CHEWABLE) RES TRIANGLE PK, NC EQ 150MG BASE
27709 (HISTAMINE H-2
RECEPTOR ANTAGONIST)
20-497 FARESTON ORION TOREMIFENE CITRATE
03-JAN-96 (TABLET) ESPOO, FINLAND EQ 60MG BASE
(NONSTEROIDAL ANTIESTROGEN)
20-552 COVERA-HS SEARLE VERAPAMIL HYDROCHLORIDE
17-JAN-96 (TABLET, SKOKIE, IL 180MG
EXTENDED RELEASE) 60077 240MG
(CALCIUM ION INFLUX
INHIBITOR)
20-234 TEGRETOL XR
CIBA GEIGY CARBAMAZEPINE
22-JAN-96 (TABLET, SUMMIT, NJ 100MG
EXTENDED RELEASE) 07901 200MG
400MG
(ANTICONVULSANT)
20-415 REMERON ORGANON MIRTAZAPINE
26-JAN-96 (TABLET) WEST ORANGE, NJ 15MG
07052 30MG
(ANTIDEPRESSANT)
20-231 TOTAL COLGATE PALMOLIVE TRICLOSAN
31-JAN-96 (DENTIFRICE) NEW YORK, NY 0.3%
10022 SODIUM FLUORIDE
0.24%
(DENTIFRICE)
(OTC)
***ORIGINAL ABBREVIATED NDAs***
40-124 CARISOPRODOL WESTWARD PHARM CARISOPRODOL
24
-JAN-96 (TABLET) EATONTOWN, NJ 350MG
07724 (SKELETAL MUSCLE
RELAXANT)
74-255 NADOLOL ZENITH NADOLOL
24-JAN-96 (TABLET) NORTHVALE, NJ 80MG
07647 120MG
160MG
(BETA ADRENERGIC BLOCKER)
74-506 CIMETIDINE INVAMED CIMETIDINE
24-JAN-96 (TABLET) DAYTON, NJ 200MG
08810 300MG
400MG
800MG
(HISTAMINE H2-RECEPTOR
ANTAGONIST)
40-100* LORTAB UCB PHARMA ACETAMINOPHEN
26-JAN-96 (TABLET)
SMYRNA, GA 500MG
30080 HYDROCODONE BITARTRATE
10MG
(ANALGESIC)
40-150 HYDROXYCHLOROQUINE INVAMED HYDROXYCHLOROQUINE SULFATE
27-JAN-96 SULFATE DAYTON, NJ 200MG
(TABLET) 08810 (ANTIMALARIAL)
64-139 AMOXICILLIN CLONMEL HLTHCARE AMOXICILLIN
29-JAN-96 (TABLET, CHEWABLE) TIPPERARY, IRELAND 125MG
250MG
(ANTIBIOTIC, PENICILLIN)
* - First Time Product Available Generically
64-047 NEOMYCIN AND BAUSCH AND LOMB GRAMICIDIN
31-JAN-96 POLYMYXIN B SULFATES TAMPA, FL 0.025MG/ML
AND GRAMICIDIN 33637 (ANTIBIOTIC, PEPTIDE)
(SOLUTION/DROPS) NEOMYCIN SULFATE
EQ 1.75MG BASE/ML
(ANTIBIOTIC,
AMINOGLYCOSIDE)
POLYMYXIN B SULFATE
10,000 UNIT/ML
(ANTIBIOTIC, PEPTIDE)
64-096 AKTOB AKORN TOBRAMYCIN
31-JAN-96 (SOLUTION/DROPS) ABITA SPRINGS, LA 0.3%
70420 (ANTIBIOTIC,
AMINOGLYCOSIDE)
73-467 TRIAMTERENE AND SIDMAK LABS NJ HYDROCHLOROTHIAZIDE
31-JAN-96 HYDROCHLOROTHIAZIDE EAST HANOVER, NJ 50MG
(TABLET) 07936 TRIAMTERENE
75MG
(DIURETIC)
***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.
74-467 RANITIDINE GENEVA PHARM RANITIDINE
31-JAN-96 (TABLET) BRO
OMFIELD, CO 150MG
80038 300MG
(HISTAMINE H-2
RECEPTOR ANTAGONIST)
74-475 TERFENADINE BAKER NORTON TERFENADINE
31-JAN-96 (TABLET) MIAMI, FL 60MG
33178 (ANTIHISTAMINE)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
20-280 GENOTROPIN PHARMACIA SOMATROPIN, BIOSYNTHETIC
20-DEC-95 (INJECTABLE) COLUMBUS, OH 5.8MG/VIAL
43216 (LABELING REVISION --
HOW SUPPLIED)
19-888 ZESTORETIC 10-12.5 ZENECA HYDROCHLOROTHIAZIDE
05-JAN-96 (TABLET) WILMINGTON, DE 12.5MG
19897 LISINOPRIL
10MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
HOW SUPPLIED)
19-888 ZESTORETIC 20-12.5 ZENECA HYDROCHLOROTHIAZIDE
05-JAN-96 (TABLET) WILMINGTON, DE 12.5MG
19897 LISINOPRIL
20MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
HOW SUPPLIED)
19-888 ZESTORETIC 20-25 ZENECA HYDROCHLOROTH
IAZIDE
05-JAN-96 (TABLET) WILMINGTON, DE 25MG
19897 LISINOPRIL
20MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
HOW SUPPLIED)
17-922 DDAVP RHONE POULENC RORER DESMOPRESSIN ACETATE
16-JAN-96 (SOLUTION) COLLEGEVILLE, PA 0.01%
19426 (LABELING REVISION --
PRECAUTIONS)
17-922 DDAVP RHONE POULENC RORER DESMOPRESSIN ACETATE
16-JAN-96 (SPRAY, METERED) COLLEGEVILLE, PA 0.01MG/INH
19426
(LABELING REVISION --
PRECAUTIONS)
20-482 PRECOSE BAYER ACARBOSE
16-JAN-96 (TABLET) WEST HAVEN, CT 50MG
06516 100MG
(LABELING REVISION --
CLINICAL TRIALS;
CONTRAINDICATIONS;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
17-031 OVRETTE WYETH AYERST NORGESTREL
18-JAN-96 (TABLET) PHILADELPHIA, PA 0.075MG
19101 (LABELING REVISION --
INDICAT
IONS AND USAGE;
PRECAUTIONS;
PATIENT PACKAGE INSERT)
50-590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM
19-JAN-96 (INJECTABLE) PHILADELPHIA, PA EQ 100MG BASE/VIAL
19101 TICARCILLIN DISODIUM
EQ 3GM BASE/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
WARNINGS;
ADVERSE REACTIONS;
OVERDOSAGE; HOW SUPPLIED)
50-590 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM
19-JAN-96 (INJECTABLE) PHILADELPHIA, PA EQ 1GM BASE/VIAL
19101 TICARCILLIN DISODIUM
EQ 30GM BASE/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
WARNINGS;
ADVERSE REACTIONS;
OVERDOSAGE; HOW SUPPLIED)
50-658 TIMENTIN SMITHKLINE BEECHAM CLAVULANATE POTASSIUM
19-JAN-96 IN PLASTIC CONTAINER PHILADELPHIA, PA EQ 100MG BASE/VIAL
(INJECTABLE) 19101 TICARCILLIN DISODIUM
EQ 3GM BASE/VIAL
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
WARNINGS;
ADVERSE REACTIONS;
OVERDOSAGE; HOW SUPPLIED)
17-970 NOLVADEX ZENECA TAMOXIFEN CITRATE
23-JAN-96 (TABLET) WILMINGTON, DE EQ 10MG BASE
19850 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; PRECAUTIONS)
18-379 DELFLEX FRESENIUS CALCIUM CHLORIDE
23-JAN-96 W/DEXTROSE 1.5% WALNUT CREEK, CA 25.7MG/100ML
IN PLASTIC CONTAINER 94598 DEXTROSE
(INJECTABLE) 1.5GM/100ML
MAGNESIUM CHLORIDE
15.2MG/100ML
SODIUM CHLORIDE
567MG/100ML
SODIUM LACTATE
392MG/100ML
(LABELING REVISION --
NEW TRADE NAME;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-379 DELFLEX FRESENIUS CALCIUM CHLORIDE
23-JAN-96 W/DEXTROSE 2.5% WALNUT CREEK, CA 25.7MG/100ML
IN PLASTIC CONTAINER 94598 DEXTRO
SE
(INJECTABLE) 2.5GM/100ML
MAGNESIUM CHLORIDE
15.2MG/100ML
SODIUM CHLORIDE
567MG/100ML
SODIUM LACTATE
392MG/100ML
(LABELING REVISION --
NEW TRADE NAME;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-379 DELFLEX FRESENIUS CALCIUM CHLORIDE
23-JAN-96 W/DEXTROSE 3.5% WALNUT CREEK, CA 25.7MG/100ML
IN PLASTIC CONTAINER 94598 DEXTROSE
(INJECTABLE) 3.5GM/100ML
MAGNESIUM CHLORIDE
15.2MG/100ML
SODIUM CHLORIDE
567MG/100ML
SODIUM LACTATE
392MG/100ML
(LABELING REVISION --
NEW TRADE NAME;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS
AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-379 DELFLEX FRESENIUS CALCIUM CHLORIDE
23-JAN-96 W/DEXTROSE 4.25% WALNUT CREEK, CA 25.7MG/100ML
IN PLASTIC CONTAINER 94598 DEXTROSE
(INJECTABLE) 4.25GM/100ML
MAGNESIUM CHLORIDE
15.2MG/100ML
SODIUM CHLORIDE
567MG/100ML
SODIUM LACTATE
392MG/100ML
(LABELING REVISION --
NEW TRA
DE NAME;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-379 DELFLEX-LM FRESENIUS CALCIUM CHLORIDE
23-JAN-96 W/DEXTROSE 1.5% WALNUT CREEK, CA 25.7MG/100ML
IN PLASTIC CONTAINER 94598 DEXTROSE
(INJECTABLE) 1.5GM/100ML
MAGNESIUM CHLORIDE
5.08MG/100ML
SODIUM CHLORIDE
538MG/100ML SODIUM LACTATE
448MG/100ML
(LABELING REVISION --
NEW TRADE NAME;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-379 DELFLEX-LM FRESENIUS CALCIUM CHLORIDE
23-JAN-96 W/DEXTROSE 2.5% WALNUT CREEK, CA 25.7MG/100ML
IN PLASTIC CONTAINER 94598 DEXTROSE
(INJECTABLE) 2.5GM/100ML
MAGNESIUM CHLORIDE
5.08MG/100ML
SODIUM CHLORIDE
538MG/100ML
SODIUM LACTATE
448MG/100ML
(LABELING REVISION --
NEW TRADE NAME;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-379 DELFLEX-LM FRESENIUS CALCIUM CHLORIDE
23-JAN-96 W/DEXTROSE 3.5% WALNUT CREEK, CA 25.7MG/100ML
IN PLAST
IC CONTAINER 94598 DEXTROSE
(INJECTABLE) 3.5GM/100ML
MAGNESIUM CHLORIDE
5.08MG/100ML
SODIUM CHLORIDE
538MG/100ML
SODIUM LACTATE
448MG/100ML
(LABELING REVISION --
NEW TRADE NAME;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
18-379 DELFLEX-LM FRESENIUS CALCIUM CHLORIDE
23-JAN-96 W/DEXTROSE 4.25% WALNUT CREEK, CA 25.7MG/100ML
IN PLASTIC CONTAINER 94598 DEXTROSE
(INJECTABLE) 4.25GM/100ML
MAGNESIUM CHLORIDE
5.08MG/100ML
SODIUM CHLORIDE
538MG/100ML
SODIUM LACTATE
448MG/100ML
(LABELING REVISION --
NEW TRADE NAME;
DESCRIPTION;
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
16-793 CYTOSAR-U UPJOHN CYTARABINE
24-JAN-96 (INJECTABLE) KALAMAZOO, MI 100MG/VIAL
49001 500MG/VIAL
1GM/VIAL
2GM/VIAL
(LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
19-085 ATROVENT BOEHRINGER INGELHEIM IPRATROPIUM BROMIDE
29-JAN-96 (AEROSOL) RIDGEFIELD, CT 0.018MG/INH
06877 (LABELING REVISION -
-
WARNINGS; PRECAUTIONS)
19-653 ORTHO CYCLEN-21 JOHNSON RW ETHINYL ESTRADIOL
29-JAN-96 (TABLET) RARITAN, NJ 0.035MG
08869 NORGESTIMATE
0.25MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
19-653 ORTHO CYCLEN-28 JOHNSON RW ETHINYL ESTRADIOL
29-JAN-96 (TABLET) RARITAN, NJ 0.035MG
08869 NORGESTIMATE
0.25MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
19-697 ORTHO TRI-CYCLEN JOHNSON RW ETHINYL ESTRADIOL
29-JAN-96 (TABLET-21 DAY) RARITAN, NJ 0.035MG,0.035MG,0.035MG
08869 NORGESTIMATE
0.18MG,0.215MG,0.25MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
19-697 ORTHO TRI-CYCLEN JOHNSON RW ETHINYL ESTRADIOL
29-JAN-96 (TABLET-28 DAY) RARITAN, NJ 0.035MG,0.035MG,0.035MG
08869 NORGESTIMATE
0.18MG,0.215MG,0.25MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS)
17-707 MPI INDIUM DTPA IN 111 MEDI PHYSICS INDIUM IN-111
30-JAN-96 (INJECTABLE) ARLINGTON HEIGHTS, IL PENTETATE DISODIUM
60005 1MCI/ML
(LABELING REVISION --
ADVERSE REACTIONS)
20-164 LOVENOX RHONE POULENC RORER ENOXAPARIN SODIUM
30-JAN-96 (INJECTABLE) COLLEGEVILLE, PA 30MG/0.3ML
19426 (LABELING REVISION --
WARNINGS; PRECAUTIONS)
20-406 PREVACID TAP HOLDINGS LANSOPRAZOLE
30-JAN-96 (CAPSULE, DEERFIELD, IL 15MG
DELAYED RELEASE 60015 30MG
GRANULES) (LABELING REVISION --
ADVERSE REACTIONS)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
1198
NONE DIAGNOSTICS TRANSFUSION BLOOD GROUPING
03-JAN-96 (INJECTABLE) LES ULIS CEDEX REAGENT (MONOCLONAL)
FRANCE (A,B)
0064 RESPIGAM MASS PUB HLTH RESPIRATORY SYNCYTIAL
18-JAN-96 (INJECTABLE) BIOLOGIC LABS VIRUS IMMUNE GLOBULIN
BOSTON, MA (B)
02130
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950054 BLOOD STORAGE REVCO LINDBERG BLOOD STORAGE REFRIGERATOR
11-JAN-96 REFRIGERATOR ASHEVILLE, NC (C)
REB 2304 28804
BK940025 KATZEN BOSTON SCI INFUSION CATHETER
24-JAN-96 THROMBOLYSIS NATICK, MA (C)
GUIDEWIRE 01760
BK950056 COBE COBE BCT AUTOMATED BLOOD CELL
31-JAN-96 SPECTRA LRS LAKEWOOD, CO
SEPARATOR
LEUKO REDUCTION 80215 (C)
SYSTEM
BK950066 BLOOD STORAGE REVCO LINDBERG BLOOD STORAGE REFRIGERATOR
31-JAN-96 REFRIGERATOR ASHEVILLE, NC (C)
HLT-30V-4BB 28804
(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
P940030 TECHNICON BAYER CORPORATION FOR QUANTITATIVE MEASUREMENT
01/30/96 IMMUNO 1 CEA TARRYTOWN, NY OF CARCINO EMBRYONIC
ASSAY SYSTEM 10591 ANTIGEN IN HUMAN SERUM FOR
THE MANAGEMENT OF CANCER
PATIENTS
***MEDICAL DEVICE - PMA SUPPLEMENTALS***
THE FOLLOWING DATA IS RECEIVED FROM THE CENTER FOR DEVICES AND RADIOLOGICAL
HEALTH AN
D IS NOT EDITED BY THE DIVISION OF DRUG INFORMATION RESOURCES PRIOR TO
PUBLICATION
N12159/S013 SURGICEL AND JOHNSON & JOHNSON 1)PROCESS CHANGE;
01/16/96 SURGICEL NU-KNIT MEDICAL, INC. 2)CHANGE OF IN-PROCESS
ABSORBABLE ARLINGTON, TX MANUFACTURING FACILITY;
HEMOSTAT 76004-3130 3)CHANGE OF QUALITY
ASSURANCE SITE; AND
4)ADDITION OF ALTERNATE
STERILIZATION SITE
N17945/S029 ADAPETTES ALCON LABORATORIES ALTERNATE STERILIZATION
01/04/96 LUBRICATING FORT WORTH, TX METHOD WHICH USES 100%
AND REWETTING 76134-2099 ETHYLENE OXIDE
SOLUTION
N17974/S049 PREFLEX ALCON LABORATORIES ALTERNATE STERILIZATION
01/04/96 DAILY CLEANING FORT WORTH, TX M
ETHOD WHICH USES
SOLUTION 76134-2099 100% ETHYLENE OXIDE
N50510/S068 VITEK SYSTEMS BIOMERIEUX OFLOXACIN TO BE INCLUDED
01/17/96 "GENERAL VITEK, INC. ON THE GRAM NEGATIVE
SUSCEPTIBILITY HAZELWOOD, MO SUSCEPTIBILITY CARD
CARD" 63042-2395 IN THREE CONCENTRATION
(EQUIVALENT TO 1, 4,
AND 10 MCG/ML)
P790017/S057 USCI GRUNTZIG C.R. BARD, INC. REVISED LABELING
01/25/96 DILACA CORONARY BILLERICA, MA
ARTERY & USCI 01821
XPRT WITH PRO/
PEL COATING
BALLOON
DILATATION
CATHETERS
P790018/S025 MEDTRONIC-HALL MEDTRONIC APPROVAL FOR THE 24MM
01/02/96 PROSTHETIC HEART CARDIAC SURGERY MEDTRONIC-HA
LL PROSTHETIC
VALVE MINNEAPOLIS, MN HEART VALVE,
55440 MODEL A7700 AHK
P800041/S015 CARBON TIP PACESETTER, INC. ADDITION OF A "NITROGEN
01/04/96 CARDIAC PACING SYLMAR, CA "BLANKET TO STERILIZATION
LEADS 93192-9221 PROCESS
P820036/S014 OPTI-CLEAN DAILY ALCON LABORATORIES, ALTERNATE STERILIZATION
01/04/96 CLEANER INC. METHOD WHICH USES 100%
FORT WORTH, TX ETHYLENE OXIDE
76134-2099
P820075/S007 LAMICEL OSMOTIC MEROCEL, CORP. RELOCATION OF CABOT'S
01/03/96 CERVICAL DILATOR MYSTIC, CT LAMICEL PROCESSING EQUIPMENT
06355-0334 AND THE ASSOCIATED METHODS
OR PROCEDURES T
O THE MEROCEL
FACILITY AT MYSTIC, CT 06355
P820076/S019 MODEL PMS 1000 BIOTRONIK, INC. APPROVAL FOR THE
01/24/96 PROGRAMMING AND LAKE OSWEGO, OR MODEL PMS 1000
MONITORING SYSTEM 97035-5369 PROGRAMMING AND MONITORING
WITH SOFTWARE SYSTEM WITH SOFTWARE
MODULE SWM 1000, MODULE SWM 1000,
VERSION C01.C02.U VERSION C01.C02.U
P830033/S027 SINGLE-PIECE SURGIDEV CORP. CHANGE IN VENDORS WHO
01/29/96 AND THREE-PIECE GOLETA, CA PROVIDE THE
ULTRAVIOLET- 93117 POLYMETHYLMETHACRYLATE
ABSORBING (PMMA) MATERIAL
ABSORBING
POSTERIOR CHAMBER
INTRAOCULAR
LENSES (IOLS)
P830037/S039 FRESHLOOK COLORS WESLEY-JESSEN INCORPORATION OF AN
01/25/96 UV AND FRESHLOOK
DES PLAINES, IL ULTRA-VIOLET ABSORBER
LITETINT UV 60018-5903 INTO THE DEVICE
(PHEMFILCON A)
SOFT (HYDROPHILIC)
CONTACT LENSES
P830055/S043 NEW JERSEY LCS DEPUY, INC. ADDITION OF GAS
01/02/96 TOTAL KNEE SYSTEM WARSAW, IN PLASMA STERILIZATION
46581-0988 FOR POLYETHYLENE COMPONENTS
P840024/S058 NUCLEUS COCHLEAR, CORP. MODIFICATION OF
01/24/96 22-CHANNEL ENGLEWOOD, CO THERAPEUTIC CLAIMS OF
COCHLEAR 80112 DEVICE EFFECTIVENESS
IMPLANT SYSTEM FOR ADULT USERS
P840041/S006 NOVAFIL AND DAVIS & GECK REVISION OF THE EXISTING
01/11/96 VASCUFIL DANBURY, CT PACKAGE INSERTS, UNDER
POLYBUTESTER 06810 THE PROVISIONS OF
MONOFILAMENT
814.39(D)(1), SPECIAL
NONABSORBABLE PMA SUPPLEMENT-CHANGES
SURGICAL SUTURE
P840051/S007 MAXON AND DAVIS & GECK REVISION OF THE EXISTING
01/11/96 MAXON CV DANBURY, CT PACKAGE INSERTS, UNDER
POLYGLYCONATE 06810 THE PROVISIONS OF
MONOFILAMENT 814.39(D)(1), SPECIAL
ABSORBABLE PMA SUPPLEMENT-CHANGES
SURGICAL SUTURE
P850035/S018 EBI SPF ELECTRO-BIOLOGY, INC. REVISIONS TO THE PATIENT
01/16/96 IMPLANTABLE PARSIPPANY, NJ BROCHURE INCLUDING
SPINAL FUSION 07054-1079 ADDITION OF MRI WARNING
STIMULATOR AND PRECAUTIONS STATEM
ENT
P860057/S001 CARPENTIER- BAXTER HEALTHCARE TRADE NAME AND DESIGN
01/04/96 EDWARDS CORP. COMPONENT CHANGES
PERICARDIAL SANTA ANA, CA
BIOPROSTHESIS, 92711-1150
MODEL 2700
P870076/S001 FALOPE-RING BAND CABOT MEDICAL, CORP. CHANGE OF STERILIZATION
01/02/96 AND APPLICATOR LANGHORNE, PA FACILITY TO THE GRIFFITH
SYSTEM 19047 MICROSCIENCE FACILITY IN
WILLOWBROOK, ILLINOIS
P880028/S006 DEXTRAN HM 32% ABBOTT LABORATORIES ALTERNATE MANUFACTURING
01/04/96 HYSTEROSCOPIC ABBOTT PARK, IL FACILITY, ROQUETTE
DISTENTION MEDIUM 60064-3537 AMERICA, INC., KEOKUK, IOWA
P880047/S003 INTERCEED JOHNSON & JOHNSON ALTERNATE STERILIZATION
01/18/9
6 ABSORBABLE MEDICAL, INC. SITE, AS WELL AS A NEW
ADHESION BARRIER ARLINGTON, TX MANUFACTURING SITE FOR
76004-9962 BULK ROLL OF INTERCEED (TC7)
ABSORBABLE ADHESION BARRIER
P880091/S005 ELASTIC LENS STARR SURGICAL CHANGE MOLDING
01/18/96 AND ELASTIMIDE COMPANY PARAMETERS
ULTRAVIOLET- MONROVIA, CA
ABSORBING 91016
SILICONE
POSTERIOR CHAMBER
INTRAOCULAR
LENSES (IOLS)
P900023/S013 ABIOMED BVS 5000 ABIOMED, INC. INCREASE OF THE LEFT SIDE
01/29/96 BI-VENTRICULAR DANVERS, MA FLOW CAPACITY BY
SUPPORT SYSTEM 01923 APPROXIMATELY 1 LITER/MINUTE
P900056/S011 ROTABLATOR HEART TECHNOLOGY, INC. REMOVAL OF THE DRIVESHAFT
01/18
/96 ROTATIONAL REDMOND, WA DISTAL HEATSHRINK
ANGIOPLASTY 98052-3376
SYSTEM
P900056/S012 ROTABLATOR HEART TECHNOLOGY, INC. APPROVAL FOR THE ROTAWIRE
01/29/96 ROTATIONAL REDMOND, WA GUIDE WIRE LINE
ANGIOPLASTY 98052-3376
SYSTEM
P910016/S007 NEW JERSEY LCS DEPUY, INC. GAS PLASMA STERILIZATION
01/02/96 TOTAL KNEE SYSTEM WARSAW, IN FOR POLYETHYLENE COMPONENTS
46581-0988
P910031/S004 CATHSCANNER ENDOSONICS, CORP. APPROVAL FOR THE 25MM
01/18/96 ORACLE MICRO RANCHO CORDOVA, CA FACT CORONARY BALLOON
PTCA CATHETER 95670 DILATATION CATHETER
P910031/S006 CATHSCANNER ENDOSONICS, CORP. ADDITIONAL MANUFACTURING
01/30/96 ORACLE MICRO PTCA RANCHO CORDOVA, CA SITE, IRVINE, CA
CATHETER FACT 95670
BALLOON CORONARY
DILATATION
CATHETER
P910058/S008 CHIROFLEX CHIRON VISION, CORP. DISTRIBUTION OF DEVICE BY
01/02/96 MODEL C1OUB CLAREMONT, CA ALLERGAN MEDICAL OPTICS
ULTRAVIOLET- 91711 AS THE AMO SINGFLEX
ABSORBING SILICONE MODEL SI-14PB ULTRAVIOLET-
POSTERIOR CHAMBER ABSORBING SILICONE
INTRAOCULAR LENS POSTERIOR CHAMBER IOL
P930031/S001 WALLSTENT TIPS SCHNEIDER (USA), INC. ADDITION OF 10 MM DIAMETER
01/29/96 (TRANSJUGULAR MINNEAPOLIS, MN BY 94 MM LENGTH WALLSTENT
INTRAHEPATIC 55442 TIPS ENDOPROSTHESIS
PORTOSYSTEMIC
SHUNT)
ENDOPROSTHESIS
***ORIGINAL VETERINARY NADAs***
THERE ARE NO ORIGINAL VETERINARY NADAs FOR JANUARY 1996.
***ORIGI
NAL ABBREVIATED VETERINARY NADAs***
200-146 OXYTETRACYCLINE CATTLE, PHOENIX SCIENTIFIC OXYTETRACYCLINE
07-DEC-95 HYDROCHLORIDE CHICKENS, ST JOSEPH, MO HYDROCHLORIDE
(POWDER) SHEEP, 64506 55MG/GM
SWINE,
TURKEYS
***SUPPLEMENTAL VETERINARY NADAs***
039-077 CSP 250 SWINE FERMENTA AN HLTH CHLORTETRACYCLINE
26-JAN-96 (PREMIX) ELWOOD, KS HYDROCHLORIDE
68024 20GM/LB
PENICILLIN
10GM/LB
SULFATHIAZOLE
20GM/LB
039-077 CSP 500 SWINE
FERMENTA AN HLTH CHLORTETRACYCLINE
26-JAN-96 (PREMIX) ELWOOD, KS HYDROCHLORIDE
68024 40GM/LB
PENICILLIN
20GM/LB
SULFATHIAZOLE
40GM/LB
Date created: July 11, 1996; last updated: June 20, 2005 |
|
|
||||||
 | ||||||
|
||||||