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FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 18 Number (11) November 1995
Center for Drug Evaluation Center for Devices and
and Research Radiological Health
*George R. Scott (301) 443-3910 Julie Stuart (301) 594-2186
Center for Biologics Center for Veterinary Medicine
Evaluation and Research
Norman Turner (301) 827-3503
Roger Eastep (301) 594-1623
*To whom general inquiries should be directed.
This report is compiled by the Division of Drug Information Resources, OM, CDER.
It is available by subscription from the National Technical Information Service,
Springfield, VA 22161.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE
NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S)
APPROVAL DATE (DOSAGE FORM) STRENGTH(S)
(CLASSIFICATION) CLASSIFICATION(S)
***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-401 TIAZAC BIOVAIL DILTIAZEM HYDROCHLORIDE
11-SEP-95 (CAPSULE, SCARBOROUGH, ONTARIO 120MG
(3 S) EXTENDED RELEASE) CANADA 180MG
240MG
300MG
360MG
(CALCIUM ION INFLUX
INHIBITOR)
[HYPERTENSION]
20-473 TAGAMET HB SMITHKLINE BEECHAM CIMETIDINE
15-NOV-95 (TABLET) PARSIPPANY, NJ 100MG
(6 S) 07054 (HISTAMINE H2-RECEPTOR
ANTAGONIST)
[PREVENTION OF MEAL-INDUCED
HEARTBURN, ACID
INDIGESTION, AND SOUR
STOMACH WHEN TAKEN
30 MINUTES PRIOR TO
CONSUMING FOOD OR
BEVERAGES]
(OTC)
20-527 PREMPRO 14/14 WYETH AYERST ESTROGENS, CONJUGATED
17-NOV-95 (TABLET 28-DAY) PHILADELPHIA, PA 0.625MG; 0.625MG
(3 S) 19101 (ESTROGEN)
MEDROXYPROGESTERONE ACETATE
2.5MG; 2.5MG
(PROGESTIN)
20-527 PREMPHASE 14/14 WYETH AYERST ESTROGENS, CONJUGATED
17-NOV-95 (TABLET 28-DAY) PHILADELPHIA, PA 0.625MG; 0.625MG
(3 S) 19101 (ESTROGEN)
MEDROXYPROGESTERONE ACETATE
NA; 5MG
(PROGESTIN)
20-564 EPIVIR GLAXO WELLCOME LAMIVUDINE
17-NOV-95 (TABLET) RES TRIANGLE PK, NC 150MG
(1 P, AA*, E**, H***) 27709 (ANTIVIRAL)
20-596 EPIVIR GLAXO WELLCOME LAMIVUDINE
17-NOV-95 (SOLUTION) RES TRIANGLE PK, NC 10MG/ML
(3 P, AA*, E**, H***) 27709 (ANTIVIRAL)
50-718 DOXIL SEQUUS PHARM DOXORUBICIN HYDROCHLORIDE
17-NOV-95 (INJECTABLE) MENLO PARK, CA (LIPOSOMAL FORMULATION)
(3 P, H***) 94025 2MG/ML
(ANTIBIOTIC, ANTITUMOR)
[TREATMENT OF AIDS-RELATED
KAPOSI'S SARCOMA IN
PATIENTS WITH DISEASE THAT
HAS PROGRESSED ON PRIOR
COMBINATION CHEMOTHERAPY
OR IN PATIENTS WHO ARE
INTOLERANT TO SUCH THERAPY]
50-724 ABELCET LIPOSOME AMPHOTERICIN B
20-NOV-95 (INJECTABLE) PRINCETON, NJ (LIPID COMPLEX FORMULATION)
(2 P) 08540 5MG/ML
(ANTIFUNGAL)
[TREATMENT OF ASPERGILLOSIS
IN PATIENTS WHO ARE
REFRACTORY TO OR INTOLERANT
OF CONVENTIONAL
AMPHOTERICIN B THERAPY]
AA* - Priority Classification AIDS Drug
E** - Drug for Severely Debilitating/Life Threatening Illness
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)
20-438 VESANOID ROCHE TRETINOIN
22-NOV-95 (CAPSULE) NUTLEY, NJ 10MG
(3 P, V****) 07110 (RETINOID)
[INDUCTION OF REMISSION IN
PATIENTS WITH ACUTE
PROMYELOCYTIC LEUKEMIA
(APL) WHO ARE REFRACTORY
TO, OR WHO HAVE RELAPSED
FROM, ANTHRACYCLINE
CHEMOTHERAPY]
19-558 PRINIVIL MERCK LISINOPRIL
24-NOV-95 (TABLET) WEST POINT, PA 2.5MG
(SUPPL-027) 19486 5MG
10MG
20MG
40MG
(NEW INDICATION --
TREATMENT OF
HEMODYNAMICALLY
STABLE PATIENTS WITHIN 24
HOURS OF ACUTE MYOCARDIAL
INFARCTION TO IMPROVE
SURVIVAL)
19-777 ZESTRIL ZENECA LISINOPRIL
24-NOV-95 (TABLET) WILMINGTON, DE 2.5MG
(SUPPL-023) 19897 5MG
10MG
20MG
40MG
(NEW INDICATION --
TREATMENT OF
HEMODYNAMICALLY
STABLE PATIENTS WITHIN 24
HOURS OF ACUTE MYOCARDIAL
INFARCTION TO IMPROVE
SURVIVAL)
20-496 AMARYL HOECHST ROUSSEL GLIMEPIRIDE
30-NOV-95 (TABLET) SOMERVILLE, NJ 1MG
(1 S) 08876 2MG
4MG
(BLOOD GLUCOSE REGULATOR)
V**** - Designated Orphan Drug
***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.
20-469 BECLOMETHASONE SCHERING BECLOMETHASONE DIPROPIONATE
09-NOV-95 DIPROPIONATE KENILWORTH, NJ MONOHYDRATE
MONOHYDRATE 07033 EQ 0.084MG DIPROP/INH
(SPRAY, METERED) (STEROID)
20-539 LAMISIL SANDOZ TERBINAFINE HYDROCHLORIDE
21-NOV-95 (TABLET) EAST HANOVER, NJ EQ 250MG BASE
07936 (ANTIFUNGAL)
20-291 COMBIVENT BOEHRINGER INGELHEIM ALBUTEROL SULFATE
22-NOV-95 (AEROSOL, METERED) RIDGEFIELD, CT EQ 0.09MG BASE/INH
06877 IPRATROPIUM BROMIDE
0.018MG/INH
(BRONCHODILATOR)
20-555 AXID AR WHITEHALL ROBINS NIZATIDINE
30-NOV-95 (TABLET) MADISON, NJ 75MG
07940 (HISTAMINE H2-RECEPTOR
ANTAGONIST)
(OTC)
***ORIGINAL ABBREVIATED NDAs***
74-536* HALOPERIDOL LACTATE UDL HALOPERIDOL LACTATE
02-NOV-95 (SOLUTION) LARGO, FL EQ 1MG BASE/ML
34641 (ANTIPSYCHOTIC)
63-322 PENTACEF SMITHKLINE BEECHAM CEFTAZIDIME
07-NOV-95 (INJECTABLE) KING OF PRUSSIA, PA (L-ARGININE FORMULATION)
19406 1GM/VIAL
2GM/VIAL
(ANTIBIOTIC, CEPHEM)
74-363 CAPTOPRIL GENEVA PHARMS CAPTOPRIL
09-NOV-95 (TABLET) BROOMFIELD, CO 12.5MG
80038 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
74-501 NADOLOL INVAMED NADOLOL
09-NOV-95 (TABLET) DAYTON, NJ 20MG
08810 40MG
80MG
(BETA ADRENERGIC BLOCKER)
74-352 LOPERAMIDE HCL HI TECH PHARMA LOPERAMIDE HYDROCHLORIDE
17-NOV-95 (SOLUTION) AMITYVILLE, NY 1MG/5ML
11701 (ANTIDIARRHEAL)
(OTC)
74-512 CLEMASTINE FUMARATE PERRIGO CLEMASTINE FUMARATE
22-NOV-95 (TABLET) ALLEGAN, MI 1.34MG
49010 (ANTIHISTAMINE)
(OTC)
64-106 MITOMYCIN FAULDING MITOMYCIN
29-NOV-95 (INJECTABLE) ELIZABETH, NJ 20MG/VIAL
07207 (ANTIBIOTIC, ANTITUMOR)
* - First Time Product Available Generically
40-104 HYDROXYCHLOROQUINE GENEVA PHARMS HYDROXYCHLOROQUINE SULFATE
30-NOV-95 SULFATE BROOMFIELD, CO 200MG
(TABLET) 80020 (ANTIMALARIAL)
40-133 HYDROXYCHLOROQUINE ROYCE LABS HYDROXYCHLOROQUINE SULFATE
30-NOV-95 SULFATE MIAMI, FL 200MG
(TABLET) 33014 (ANTIMALARIAL)
64-050 CLINDAMYCIN CLAY PARK CLINDAMYCIN PHOSPHATE
30-NOV-95 PHOSPHATE BRONX, NY EQ 1% BASE
(SOLUTION) 10457 (ANTIBIOTIC, LINCOMYCIN)
64-071 PENICILLIN V BIOCHEMIE PENICILLIN V POTASSIUM
30-NOV-95 POTASSIUM TYROL, AUSTRIA EQ 250MG BASE
(TABLET) EQ 500MG BASE
(ANTIBIOTIC, PENICILLIN)
74-394 DICLOFENAC SODIUM GENEVA PHARMS DICLOFENAC SODIUM
30-NOV-95 (TABLET, BROOMFIELD, CO 75MG
DELAYED RELEASE) 80038 (NONSTEROIDAL
ANTI-INFLAMMATORY)
74-621 MEGESTROL ACETATE BARR MEGESTROL ACETATE
30-NOV-95 (TABLET) POMONA, NY 40MG
10970 (PROGESTERONE DERIVATIVE)
***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.
74-493 CAPTOPRIL PAR CAPTOPRIL
14-NOV-95 (TABLET) SPRING VALLEY, NY 12.5MG
10977 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
19-543 ELOCON SCHERING MOMETASONE FUROATE
03-OCT-95 (OINTMENT) KENILWORTH, NJ 0.1%
07033 (LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
19-625 ELOCON SCHERING MOMETASONE FUROATE
03-OCT-95 (CREAM) KENILWORTH, NJ 0.1%
07033 (LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
19-970 NITROGLYCERIN BAXTER NITROGLYCERIN
03-NOV-95 IN DEXTROSE 5% ROUND LAKE, IL 10MG/100ML
(INJECTABLE) 60073 20MG/100ML
40MG/100ML
(LABELING REVISION --
PRECAUTIONS)
50-689 MYCOBUTIN PHARMACIA RIFABUTIN
03-NOV-95 (CAPSULE) COLUMBUS, OH 150MG
43216 (LABELING REVISION --
ADVERSE REACTIONS)
14-694 HEXADROL ORGANON DEXAMETHASONE SODIUM
08-NOV-95 (INJECTABLE) WEST ORANGE, NJ PHOSPHATE
07052 EQ 4MG PHOSPHATE/ML
EQ 10MG PHOSPHATE/ML
(LABELING REVISION --
WARNINGS)
18-780 HUMULIN R LILLY INSULIN BIOSYNTHETIC HUMAN
09-NOV-95 (INJECTABLE) INDIANAPOLIS, IN 100 UNITS/ML
46285 (LABELING REVISION --
PATIENT PACKAGE INSERT)
(OTC)
18-781 HUMULIN N LILLY INSULIN SUSPENSION ISOPHANE
09-NOV-95 (INJECTABLE) INDIANAPOLIS, IN BIOSYNTHETIC HUMAN
46285 100 UNITS/ML
(LABELING REVISION --
PATIENT PACKAGE INSERT)
(OTC)
19-717 HUMULIN 70/30 LILLY INSULIN BIOSYNTHETIC HUMAN
09-NOV-95 (INJECTABLE) INDIANAPOLIS, IN 30 UNITS/ML
46285 INSULIN SUSPENSION ISOPHANE
BIOSYNTHETIC HUMAN
70 UNITS/ML
(LABELING REVISION --
PATIENT PACKAGE INSERT)
(OTC)
20-015 AMINOSYN II ABBOTT AMINO ACIDS
09-NOV-95 IN PLASTIC CONTAINER ABBOTT PARK, IL 10%
(INJECTABLE) 60064 (LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION)
50-497 TICAR SMITHKLINE BEECHAM TICARCILLIN DISODIUM
09-NOV-95 (INJECTABLE) PHILADELPHIA, PA EQ 1GM BASE/VIAL
19101 EQ 3GM BASE/VIAL
EQ 20GM BASE/VIAL
EQ 30GM BASE/VIAL
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; OVERDOSAGE;
DIRECTIONS FOR USE;
STABILITY AND STORAGE
CONDITIONS;
STABILITY PERIOD;
HOW SUPPLIED)
50-672 CEFTIN GLAXO WELLCOME CEFUROXIME AXETIL
09-NOV-95 (POWDER FOR RES TRIANGLE PK, NC EQ 125MG BASE/5ML
RECONSTITUTION) 27709 (LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION)
19-777 ZESTRIL ZENECA LISINOPRIL
15-NOV-95 (TABLET) WILMINGTON, DE 2.5MG
19897 5MG
10MG
20MG
40MG
(LABELING REVISION --
DESCRIPTION;
ADVERSE REACTIONS;
HOW SUPPLIED)
20-103 ZOFRAN GLAXO WELLCOME ONDANSETRON HYDROCHLORIDE
16-NOV-95 (TABLET) RES TRIANGLE PK, NC EQ 4MG BASE
27709 EQ 8MG BASE
(LABELING REVISION --
OVERDOSAGE)
20-068 FOSCAVIR ASTRA FOSCARNET SODIUM
17-NOV-95 (INJECTABLE) WESTBOROUGH, MA 24MG/ML
01581 (LABELING REVISION --
DOSAGE AND ADMINISTRATION)
50-324 NEODECADRON MERCK DEXAMETHASONE SODIUM
20-NOV-95 (OINTMENT) WEST POINT, PA PHOSPHATE
19486 EQ 0.05% PHOSPHATE
NEOMYCIN SULFATE
EQ 3.5MG BASE/GM
(LABELING REVISION --
LABELING FORMAT
REVISION PROGRAM)
20-239 KYTRIL SMITHKLINE BEECHAM GRANISETRON HYDROCHLORIDE
21-NOV-95 (INJECTABLE) KING OF PRUSSIA, PA EQ 1MG BASE/ML
19406 (LABELING REVISION --
ADVERSE REACTIONS)
10-151 DILANTIN PARKE DAVIS PHENYTOIN SODIUM
22-NOV-95 (INJECTABLE) MORRIS PLAINS, NJ 50MG/ML
07950 (LABELING REVISION --
HOW SUPPLIED)
19-851 LOTENSIN CIBA BENAZEPRIL HYDROCHLORIDE
22-NOV-95 (TABLET) SUMMIT, NJ EQ 5MG BASE
07901 EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
20-386 COZAAR MERCK LOSARTAN POTASSIUM
22-NOV-95 (TABLET) WEST POINT, PA 25MG
19486 50MG
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
20-387 HYZAAR MERCK HYDROCHLOROTHIAZIDE
22-NOV-95 (TABLET) WEST POINT, PA 12.5MG
19486 LOSARTAN POTASSIUM
50MG
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-558 PRINIVIL MERCK LISINOPRIL
24-NOV-95 (TABLET) WEST POINT, PA 2.5MG
19486 5MG
10MG
20MG
40MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
19-777 ZESTRIL ZENECA LISINOPRIL
24-NOV-95 (TABLET) WILMINGTON, DE 2.5MG
19897 5MG
10MG
20MG
40MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
18-644 WELLBUTRIN GLAXO WELLCOME BUPROPION HYDROCHLORIDE
27-NOV-95 (TABLET) RES TRIANGLE PK, NC 75MG
27709 100MG
(LABELING REVISION --
DESCRIPTION;
ADVERSE REACTIONS;
HOW SUPPLIED)
18-257 TONOCARD ASTRA MERCK TOCAINIDE HYDROCHLORIDE
28-NOV-95 (TABLET) WAYNE, PA 400MG
19087 600MG
(LABELING REVISION --
WARNINGS)
18-956 OMNIPAQUE 140 NYCOMED IOHEXOL
28-NOV-95 (INJECTABLE) PRINCETON, NJ 30.2%
08540 (LABELING REVISION --
HOW SUPPLIED)
18-956 OMNIPAQUE 180 NYCOMED IOHEXOL
28-NOV-95 (SOLUTION) PRINCETON, NJ 38.8%
08540 (LABELING REVISION --
HOW SUPPLIED)
18-956 OMNIPAQUE 210 NYCOMED IOHEXOL
28-NOV-95 (INJECTABLE) PRINCETON, NJ 45.3%
08540 (LABELING REVISION --
HOW SUPPLIED)
18-956 OMNIPAQUE 240 NYCOMED IOHEXOL
28-NOV-95 (SOLUTION) PRINCETON, NJ 51.8%
08540 (LABELING REVISION --
HOW SUPPLIED)
18-956 OMNIPAQUE 300 NYCOMED IOHEXOL
28-NOV-95 (SOLUTION) PRINCETON, NJ 64.7%
08540 (LABELING REVISION --
HOW SUPPLIED)
18-956 OMNIPAQUE 350 NYCOMED IOHEXOL
28-NOV-95 (SOLUTION) PRINCETON, NJ 75.5%
08540 (LABELING REVISION --
HOW SUPPLIED)
19-081 ESTRADERM CIBA ESTRADIOL
28-NOV-95 (FILM, SUMMIT, NJ 0.05MG/24HR
EXTENDED RELEASE) 07901 0.1MG/24HR
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PATIENT PACKAGE INSERT)
06-799 RUBRAMIN PC SQUIBB CYANOCOBALAMIN
29-NOV-95 (INJECTABLE) NEW BRUNSWICK, NJ 1MG/ML
08903 (LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-384 NOROXIN MERCK NORFLOXACIN
29-NOV-95 (TABLET) WEST POINT, PA 400MG
19486 (LABELING REVISION --
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS)
20-144* TRANSDERM-NITRO CIBA NITROGLYCERIN
29-NOV-95 (FILM, SUMMIT, NJ 0.1MG/HR
EXTENDED RELEASE) 07901 0.2MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
(LABELING REVISION --
PRECAUTIONS)
20-406 PREVACID TAP HOLDINGS LANSOPRAZOLE
30-NOV-95 (CAPSULE, DEERFIELD, IL 15MG
DELAYED RELEASE 60015 30MG
GRANULES) (LABELING REVISION --
PRECAUTIONS)
* - Permitted
***BIOLOGICAL PRODUCT LICENSES ISSUED***
0467 CANDIN ALLERMED LABS CANDIDA ALBICANS
27-NOV-95 SAN DIEGO, CA SKIN TEST ANTIGEN
92111 (B)
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950057 THE SABER SG SCIENTIFIC SEGMENT PIERCING DEVICE
13-NOV-95 GAINESVILLE, FL (C)
32608
BK950058 TERUMO SAMPLING TERUMO MED SAMPLING SITE COUPLER
13-NOV-95 SITE COUPLER ELKTON, MD (C)
21921
BK950018 TOTAL CONTAINMENT DENCO STERILE CONNECTION DEVICE
14-NOV-95 DEVICE WILMINGTON, DE (C)
19809
BK950024 COBE PLATELET COBE BCT ACCESSARY FOR AUTOMATED
29-NOV-95 FILTRATION AND LAKEWOOD, CO BLOOD CELL SEPARATOR
STORAGE SET 80215 (C)
BK940047 OLYMPUS PK TP SCHIFF REAGENT FOR HEMAGGLUTINATION
29-NOV-95 SYSTEM REACTIVE W CALDWELL, NJ TEST FOR SYPHILIS
CONTROL 07006 (C)
BK940053 OLYMPUS PK TP SCHIFF HEMAGGLUTINATION TEST FOR
29-NOV-95 SYSTEM W CALDWELL, NJ DETECTION OF TREPONEMA
07006 PALLIDUM ANTIBODY
(C)
***ERRATA***
BK950050* MULTIPLE IZON BUSINESS PRODS HIV ORAL SPECIMEN &
(IZON HIV ORAL NEW YORK, NY URINE COLLECTION KIT
SPECIMEN & URINE 10994 (C)
COLLECTION KIT)
* - Erroneously listed as approved in October 1995 FDA Drug and Device Product
Approvals.
(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
P940008 RES-Q ACD INTERMEDICS, INC. INDICATED FOR USE
11/28/95 ARRHYTHMIA ANGLETON, TX IN PATIENTS WHO ARE
CONTROL DEVICE 77515 AT HIGH RISK OF
EPICARDIAL PATCH SUDDEN DEATH DUE TO
AND NONTHORACOTOMY VENTRICULAR
LEAD (NTL) SYSTEMS ARRHYTHMIAS AND HAVE
CERTAIN OTHER CONDITIONS
P940018 BARD BTA TEST KIT BARD DIAGNOSTIC INTENDED FOR USE IN THE
11/29/95 SCIENCES, INC. QUALITATIVE MEASUREMENT OF
REDMOND, WA BLADDER TUMOR ASSOCIATED
98052 ANALYTES IN HUMAN URINE TO
AID IN THE MANAGEMENT OF
BLADDER CANCER PATIENTS
P940029 PAPNET NEUROMEDICAL THE DEVICE IS A
11/08/95 TESTING SYSTEM SYSTEMS, INC. SEMI-AUTOMATED TEST
SUFFERN, NY INDICATED TO AID IN
10901 THE RESCREENING OF CERVICAL
PAPANICOLAOU (PAP)
SMEARS PREVIOUSLY
REPORTED AS NEGATIVE
***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
N17004/S005 SURGICAL HOWMEDICA, INC STERILIZATION
11/21/95 SIMPLEX P RUTHERFORD, NJ PROCESS CHANGE
RADIOPAQUE BONE 07070-2584
CEMENT
N17755/S046 OSTEOBOND ZIMMER, INC. ADDITION OF
11/20/95 COPOLYMER BONE WARSAW, IN WARNING STATEMENT
CEMENT 46581-0708 TO LABELING
N18331/S025 PDS II ETHICON, INC. APPROVAL FOR USE OF
11/02/95 (POLYDIOXANOE) SOMERVILLE, NJ THE PDS II SUTURE IN
SUTURE, DYED & 08876 THE PANALOK
UNDYED ABSORBABLE SUTURE
ANCHOR SYSTEM
N18466/S019 CMW 1 WRIGHT MEDICAL APPROVAL FOR CMW 1
11/20/95 RADIOPAQUE, TECHNOLOGY, INC. RADIOPAQUE, CMW2 AND
CMW2 AND CMW3 ARLINGTON, TN CMW3 TO BE MARKETED
BONE CEMENTS 38002 UNDER WRIGHT MEDICAL
AS: ORTHOSET 1,
ORTHOSET 2, AND
ORTHOSET 3 BONE CEMENT
N18466/S020 CMW1 RADIOPAQUE WRIGHT MEDICAL ADDITION OF
11/20/95 CMW2 AND CMW3 TECHNOLOGY, INC. DISTRIBUTOR LABEL
BONE CEMENTS ARLINGTON, TN AND STERILE POWDER
38002 PACKAGE PLACED INTO
A NONSTERILE PROTECTIVE
LAMINATED FOIL POUCH
N50510/S063 VITEK BIOMERIEUX APPROVAL FOR THE
11/16/95 LOMEFLOXACIN VITEK, INC. ADDITION OF THE
HAZELWOOD, MO ANTIMICROBIAL
63042-2395 LOMEFLOXACIN TO THE
VITEK GRAM NEGATIVE
ANTIMICROBIAL PANELS
N50510/S064 VITEK BIOMERIEUX APPROVAL FOR THE
11/27/95 PIPERACILLIN/ VITEK, INC. ADDITION OF THE
TAZOBACTAM HAZELWOOD, MO ANTIMICROBIAL
63042-2395 PIPERACILLIN/TAZOBACTAM
TO THE VITEK GRAM
NEGATIVE
ANTIMICROBIAL PANELS
P800022/S049 ZYPLAST COLLAGEN COLLAGEN CORPORATION APPROVAL FOR THE USE
11/30/95 IMPLANT ZYDERM I PALO ALTO, CA OF A RANGE OF FILL
AND II COLLAGEN 94303 VOLUMES FOR THE ABOVE
IMPLANT REFERENCED PRODUCTS
FROM 0.1ML (TEST DOSE)
TO 3ML
P810002/S036 ST. JUDE MEDICAL ST. JUDE APPROVAL FOR A ROTATABLE
11/28/95 MECHANICAL HEART MEDICAL, INC. VERSION OF THE DEVICE -
VALVE ST. PAUL, MN THE DEVICE AS MODIFIED
55117 WILL BE MARKETED
UNDER: ST. JUDE MEDICAL
MASTER SERIES
P810046/S156 ACS ADVANCED APPROVAL FOR AN
11/07/95 SIMPSON-ROBERT CARDIOVASCULAR ALTERNATIVE PACKAGING
CORONARY BALLOON SANTA CLARA, CA CONFIGURATION FOR THE
DILATATION CATHETER 95052-8167 FINAL PRODUCT PACKAGING
FOR ACS CORONARY
DILATATION CATHETERS
P830045/S050 AFP CARDIAC PACESETTER, INC. APPROVAL FOR THE
11/13/95 PACING SYSTEM, SYLMAR, CA INCORPORATION OF A
SENSOLOG CARDIAC 91392-9221 "NITROGEN BLANKET" TO
PACING SYSTEM, THE STERILIZATION
AND SYNCHRONY PROCESS USED AT THE
CARDIAC PACING SYLMAR, CA, FACILITY
SYSTEM OF PACESETTER, INC.
P830055/S040 NEW JERSEY LCS DEPUY INC. APPROVAL FOR ADDITION
11/01/95 TOTAL KNEE SYSTEM WARSAW, IN OF A CONTRACT
46581-0988 STERILIZATION VENDOR,
SWANN-MORTON LIMITED,
OWLERTON GREEN,
SHEFFIELD, ENGLAND
P830055/S041 NEW JERSEY LCS DEPUY INC. APPROVAL OF ETHYLENE
11/06/95 TOTAL KNEE SYSTEM WARSAW, IN OXIDE STERILIZATION
46581-0988 FOR POLYETHYLENE
COMPONENTS AS AN
ALTERNATIVE TO GAMMA
RADIATION STERILIZATION
P830060/S038 VENTAK GUIDANT, CORP. APPROVAL FOR AN
11/20/95 AUTOMATIC ST. PAUL, MN ALTERNATE
IMPLANTABLE 55112 MANUFACTURING SITE
CARDIOVERTER FOR ASSEMBLY OF THE
DEFIBRILLATOR EXTERNAL PRODUCTS
(AICD) SYSTEM
P840068/S025 DELTA GUIDANT, CORP. APPROVAL FOR
11/20/95 PACEMAKER SYSTEM ST. PAUL, MN ALTERNATE
55112 MANUFACTURING SITE
FOR ASSEMBLY OF THE
EXTERNAL PRODUCTS
P850021/S029 AMERICAN EDWARDS BAXTER NEW MODEL
11/27/95 LABORATORIES HEALTHCARE CORP. PURSUIT 14 PTCA
HYBRID PTCA SANTA ANA, CA CATHETER
CATHETER, 92711-1150
PURSUIT 14
PTCA CATHETER
P850048/S011 TANDEM-R PSA HYBRITECH, INC. APPROVAL FOR INCLUSION
11/06/95 IMMUNORADIO- SAN DIEGO, CA OF INFORMATION AND
METRIC ASSAY 92126 DATA ON PSA FORMS IN
IMMUNOMETRIC THE TANDEM PSA LABELING
TANDEM-E PSA
IMMUNORADIO-
METRIC ASSAY
P860019/S102 SCIMED SCIMED LIFE NEW MANUFACTURING
11/20/95 PERCUTANEOUS SYSTEMS, INC. FACILITY AND MANUFACTURE
TRANSLUMINAL MAPLE GROVE, MN OF THE TRAPPER PTCA
CORONARY 55311-1566 CATHETER IN A NON-
ANGIOPLASTY CLEANROOM ENVIRONMENT
CATHETERS AND
TRAPPER EXCHANGE
DEVICE
P860040/S013 BIOCURVE SOFT EW CAL BIONICS RELOCATION OF ALTERNATE
11/27/95 (METHAFILCON A) NOVATO, CA MANUFACTURER AND A CHANGE
HYDROPHILIC 94947 IN THE STERILIZATION
CONTACT LENSES PROCESS
P880006/S023 AFP CARDIAC PACESETTER, INC. APPROVAL FOR THE
11/13/95 PACING SYSTEM, SYLMAR, CA INCORPORATION OF A
SENSOLOG CARDIAC 91392-9221 "NITROGEN BLANKET" TO
PACING SYSTEM, THE STERILIZATION
AND SYNCHRONY PROCESS USED AT THE
CARDIAC PACING SYLMAR, CA, FACILITY
SYSTEM OF PACESETTER, INC.
P880027/S036 SCHNEIDER SCHNEIDER (USA) INC. DESIGN CHANGES, NEW
11/21/95 MICROSOFTRAC MINNEAPOLIS, MN LABELING, REVISED
PTCA CATHETER 55442 PACKAGING, NEW MATERIAL,
SCHNEIDER ADDITIONAL SIZES
FREEFLIGHT
20/30/40
PTCA CATHETER
P880072/S037 MODIFIED J & C MEDICAL DEVELOPMENT APPROVAL FOR TIER A
11/01/95 LOOP MODEL PA36 RESEARCH, INC. POSTERIOR CHAMBER
POSTERIOR CHAMBER ST. PETERSBURG, FL INTRAOCULAR LENS
INTRAOCULAR LENS 33716 MODEL PA84B-OUV
P880086/S032 SYNCHRONY III PACESETTER, INC. APPROVAL FOR
11/01/95 AND PARAGON III SYLMAR, CA ALTERNATIVE HYBRID
DUAL-CHAMBER 91392-9221 SUBSTRATE
PULSE GENERATORS
P880086/S033 TRILOGY PACESETTER, INC. APPROVAL FOR
11/01/95 PULSE GENERATOR SYLMAR, CA ALTERNATIVE HYBRID
MODELS 235OL, 91392-9221 SUBSTRATE
2250L, AND 2308L
P880086/S034 AFP CARDIAC PACESETTER, INC. APPROVAL FOR THE
11/13/95 PACING SYSTEM, SYLMAR, CA INCORPORATION OF A
SENSOLOG CARDIAC 91392-9221 "NITROGEN BLANKET" TO
PACING SYSTEM, THE STERILIZATION
AND SYNCHRONY PROCESS USED AT THE
CARDIAC PACING SYLMAR, CA, FACILITY
SYSTEM OF PACESETTER, INC.
P890061/S010 VENTAK(R) P GUIDANT, CORP. APPROVAL FOR
11/20/95 AICD SYSTEM ST. PAUL, MN ALTERNATE MANUFACTURING
55112 SITE FOR ASSEMBLY OF
THE EXTERNAL PRODUCTS
P900023/S017 ABIOMED(R) BVS ABIOMED, INC. APPROVAL FOR THE
11/30/95 BVS 5000 DANVERS, MA ADDITION OF REFERENCE
BI-VENTRICULAR 01923 CARDS TO BE PLACED IN
SUPPORT SYSTEM A HOLDER ATTACHED TO
THE CONSOLE
P900061/S018 MEDTRONIC PCD MEDTRONIC, INC. APPROVAL FOR USE OF AN
11/29/95 TACHYARRHYTHMIA MINNEAPOLIS, MN ALTERNATE STERILIZATION
CONTROL SYSTEM 55432-3576 PROCESS AND A
MODIFICATION TO THE
DISTAL END OF THE
TRANSVENE LEADS
P900061/S019 MODEL 9881E MEDTRONIC, INC. APPROVAL FOR MODEL
11/06/95 SOFTWARE MINNEAPOLIS, MN 9881E SOFTWARE, 9881E
(9881E 217214 55432-3576 217214 REVISION:C, FOR
REVISION:C) MODEL 9790 AND 9790C
PROGRAMMERS WITH
MODEL 7216/7217 PCD
AND 7201 CD DEVICES
P910054/S001 INOUE BALLOON TORAY INDUSTRIES APPROVAL FOR A
11/30/95 CATHETER (AMERICA), INC. MODIFICATION OF THE
NEW YORK, NY STERILIZATION CYCLE
10016-4279
P910064/S011 REALITY WISCONSIN APPROVAL FOR A CHANGE
11/16/95 FEMALE CONDOM PHARMACAL CO. IN THE TYPE OF PACKAGING
CHICAGO, IL USED TO SUPPLY THE EXTRA
60611 LUBRICANT THAT IS SOLD
WITH REALITY
P910073/S015 ENDOTAK LEAD GUIDANT, CORP. MODIFICATIONS TO
11/27/95 SYSTEM ST. PAUL, MN LEAD COMPONENTS
55112-5798 LEAD BODY DIAMETER,
NEW TRADE NAMES
P910077/S007 VENTAK PRX AICD GUIDANT, CORP. APPROVAL FOR ALTERNATE
11/20/95 SYSTEM ST. PAUL, MN MANUFACTURING SITE
55112 FOR ASSEMBLY OF THE
EXTERNAL PRODUCTS
P920014/S002 TCI HEARTMATE THERMO APPROVAL FOR AN
11/17/95 IP LVAS CARDIOSYSTEMS, INC. INTERIM DESIGN CHANGE
WOBURN, MA OF THE PERCUTANEOUS
01888-2697 VENT LEAD (PVL)
P920047/S001 EPT-1000 TC EP TECHNOLOGIES, INC. ALTERNATE
11/08/95 CARDIAC ABLATION SUNNYVALE, CA CONFIGURATION OF
SYSTEM WITH 94086 THE EPT-1000 CARDIAC
TEMPERATURE ABLATION CONTROLLER
CONTROL WHICH INCORPORATES
A TEMPERATURE CONTROL
FEATURE
P930030/S001 ACTIFOAM BIOETICA, INC. APPROVAL FOR A CHANGE
11/30/95 ABSORBABLE PORTLAND, ME IN TRADE NAME THE
COLLAGEN 04101 DEVICE AS MODIFIED
HEMOSTATIC SPONGE WILL BE MARKETED
UNDER THE TRADE NAME
ACTIFOAM ABSORBABLE
COLLAGEN HEMOSTATIC
SPONGE
P930035/S003 VENTAK P2 GUIDANT, CORP. APPROVAL FOR ALTERNATE
11/20/95 AICD SYSTEM ST. PAUL, MN MANUFACTURING SITE
55112 FOR ASSEMBLY OF
EXTERNAL PRODUCTS
***ORIGINAL VETERINARY NADAs***
141-018 SARAFLOX BROILER ABBOTT LABS SARAFLOXACIN
12-OCT-95 (SOLUTION) CHICKS N CHICAGO, IL HYDROCHLORIDE
60064 50MG/ML
***ORIGINAL ABBREVIATED VETERINARY NADAs***
200-109 VELENIUM CATTLE FT DODGE LABS SELENIUM
20-OCT-95 (EMULSION) FT DODGE, IA 5MG/ML
50501 VITAMIN E
50MG/ML
***SUPPLEMENTAL VETERINARY NADAs***
096-298 AVATEC RABBITS HOFFMANN LA ROCHE LASALOCID SODIUM
20-OCT-95 (PREMIX) NUTLEY, NJ 20%
07110
Date created: October 30, 1996; last updated: June 20, 2005 |
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