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Drug and Device Approvals-April 1995
**ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-145 NITRO-DUR KEY PHARMS NITROGLYCERIN
04-APR-95 (FILM, KENILWORTH, NJ 0.1MG/HR
(SUPPL-004)EXTENDED RELEASE) 07033 0.2MG/HR
0.3MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
(VASODILATOR)
[PREVENTION OF
ANGINA
PECTORIS]
19-829 CERETEC AMERSHAM TECHNETIUM TC-99M
07-APR-95 (INJECTABLE) ARLINGTON HEIGHTS, IL EXAMETAZIME KIT
(SUPPL-005) 60005 N/A
(NEW INDICATION --
LEUCOCYTE LABELED
SCINTIGRAPHY AS AN
ADJUNCT
IN THE LOCALIZATION
OF
INTRA-ABDOMINAL
INFECTION
AND INFLAMMATORY
BOWEL
DISEASE)
20-103 ZOFRAN GLAXO ONDANSETRON
HYDROCHLORIDE
10-APR-95 (TABLET) RES TRIANGLE PK, NC EQ 4MG BASE
(SUPPL-008) 27709 EQ 8MG BASE
(NEW DOSAGE REGIMEN
--
BID DOSING IN
PATIENTS
12 YEARS OF AGE AND
OLDER
FOR PREVENTION OF
NAUSEA
AND VOMITING
ASSOCIATED
WITH MODERATELY
EMETOGENIC
CANCER
CHEMOTHERAPY)
20-386 COZAAR MERCK LOSARTAN POTASSIUM
14-APR-95 (TABLET) WEST POINT, PA 25MG
(1 S) 19486 50MG
(ANGIOTENSIN II
RECEPTOR
ANTAGONIST)
[HYPERTENSION]
20-459 REVEX OHMEDA NALMEFENE
HYDROCHLORIDE
17-APR-95 (INJECTABLE) LIBERTY CORNER, NJ EQ 0.1MG BASE/ML
(1 S) 07938 EQ 1MG BASE/ML
(OPIOID ANTAGONIST)
[COMPLETE OR
PARTIAL
REVERSAL OF OPIOID
DRUG
EFFECTS, INCLUDING
RESPIRATORY
DEPRESSION,
INDUCED BY EITHER
NATURAL
OR SYNTHETIC
OPIOIDS]
20-103 ZOFRAN GLAXO ONDANSETRON
HYDROCHLORIDE
19-APR-95 (TABLET) RES TRIANGLE PK, NC EQ 4MG BASE
(SUPPL-005) 27709 EQ 8MG BASE
(NEW INDICATION --
PREVENTION OF
POSTOPERATIVE
NAUSEA AND
VOMITING)
20-312 UNIVASC SPKU MOEXIPRIL
HYDROCHLORIDE
19-APR-95 (TABLET) MILWAUKEE, WI 7.5MG
(1 S) 53201 15MG
(ANGIOTENSIN
CONVERTING
ENZYME INHIBITOR)
[HYPERTENSION]
20-402 PROVEL SANDOZ IBUPROFEN
20-APR-95 (CAPSULE) EAST HANOVER, NJ 200MG
(3 S) 07936 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
18-938 DDAVP RHONE POULENC RORER DESMOPRESSIN
ACETATE
25-APR-95 (INJECTABLE) COLLEGEVILLE, PA 0.015MG/ML
(SUPPL-011) 19426 (NEW STRENGTH)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
28-APR-95 (TABLET) WILMINGTON, DE 1MG
(SUPPL-076) 19880 2MG
2.5MG
4MG
5MG
7.5MG
10MG
(NEW INDICATION --
TO REDUCE THE RISK
OF DEATH,
RECURRENT
MYOCARDIAL
INFARCTION, AND
THROMBOEMBOLIC
EVENTS SUCH
AS STROKE OR
SYSTEMIC
EMBOLIZATION AFTER
MYOCARDIAL
INFARCTION)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
28-APR-95 (INJECTABLE) WILMINGTON, DE 5MG
(SUPPL-076) 19880 (NEW INDICATION --
TO REDUCE THE RISK
OF DEATH,
RECURRENT
MYOCARDIAL
INFARCTION, AND
THROMBOEMBOLIC
EVENTS SUCH
AS STROKE OR
SYSTEMIC
EMBOLIZATION AFTER
MYOCARDIAL
INFARCTION)
20-325 PEPCID AC MERCK FAMOTIDINE
28-APR-95 (TABLET) WEST POINT, PA 10MG
(6 S) 19486 (HISTAMINE H2-
RECEPTOR
ANTAGONIST)
[PREVENTION AND
TREATMENT OF
FOOD AND BEVERAGE
INDUCED
HEARTBURN, ACID
INDIGESTION,
AND SOUR STOMACH]
(OTC)
20-387 HYZAAR MERCK HYDROCHLOROTHIAZIDE
28-APR-95 (TABLET) WEST POINT, PA 12.5MG
(4 S) 19486 (DIURETIC)
LOSARTAN POTASSIUM
50MG
(ANGIOTENSIN II
RECEPTOR
ANTAGONIST)
[HYPERTENSION]
***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.
19-821 SORIATANE ROCHE ACITRETIN
03-APR-95 (CAPSULE) NUTLEY, NJ 10MG
07110 25MG
(RETINOID)
[TREATMENT OF
SEVERE
RECALCITRANT
PSORIASIS]
20-325 PEPCID AC MERCK FAMOTIDINE
17-APR-95 (TABLET) WEST POINT, PA 10MG
19486 (HISTAMINE H2-
RECEPTOR
ANTAGONIST)
[PREVENTION AND
TREATMENT OF
FOOD AND BEVERAGE
INDUCED
HEARTBURN, ACID
INDIGESTION,
AND SOUR STOMACH]
(OTC)
20-059 ADENOSCAN MEDCO RES ADENOSINE
18-APR-95 (INJECTABLE) RES TRIANGLE PK, NC 3MG/ML
22709 (NUCLEOSIDE)
[ADJUNCT TO
THALLIUM-201
MYOCARDIAL
PERFUSION
SCINTIGRAPHY IN
PATIENTS
UNABLE TO EXCERISE
ADEQUATELY]
20-320 DEPAKOTE ABBOTT DIVALPROEX
20-APR-95 (TABLET, ABBOTT PARK, IL EQ 125MG BASE
DELAYED RELEASE) 60064 EQ 250MG BASE
EQ 500MG BASE
(ANTICONVULSANT/ANTIMANIC)
[TREATMENT OF MANIC
PHASE
OF BIPOLAR
DISORDER]
20-377 CORDARONE WYETH AYERST AMIODARONE
HYDROCHLORIDE
25-APR-95 (INJECTABLE) PHILADELPHIA, PA 50MG/ML
19101 (ANTIARRHYTHMIC)
***ORIGINAL ABBREVIATED NDAs***
74-149 GUANABENZ ACETATE ZENITH LABS GUANABENZ ACETATE
07-APR-95 (TABLET) NORTHVALE, NJ EQ 4MG BASE
07647 EQ 8MG BASE
(ANTIHYPERTENSIVE)
74-305 GLIPIZIDE GENEVA PHARMS GLIPIZIDE
07-APR-95 (TABLET) BROOMFIELD, CO 5MG
80038 10MG
(BLOOD GLUCOSE
REGULATOR)
73-690* CALCITONIN-SALMON ASTRA CALCITONIN, SALMON
14-APR-95 (INJECTABLE) WESTBOROUGH, MA 200IU/ML
01581 (CALCIUM REGULATOR)
64-117 MITOMYCIN CETUS BEN VENUE MITOMYCIN
19-APR-95 (INJECTABLE) EMERYVILLE, CA 5MG/VIAL
94608 20MG/VIAL
(ANTIBIOTIC,
ANTITUMOR)
74-225* BUMETANIDE ZENITH LABS BUMETANIDE
24-APR-95 (TABLET) NORTHVALE, NJ 0.5MG
07647 1MG
2MG
(LOOP DIURETIC)
74-288* ACEBUTOLOL HCL MYLAN ACEBUTOLOL
HYDROCHLORIDE
24-APR-95 (CAPSULE) MORGANTOWN, WV EQ 200MG BASE
26505 EQ 400MG BASE
(BETA ADRENERGIC
BLOCKER)
64-061 CEFACLOR ZENITH CEFACLOR
27-APR-95 (CAPSULE) NORTHVALE, NJ EQ 250MG BASE
07647 EQ 500MG BASE
(ANTIBIOTIC,
CEPHEM)
* First Time Product Available Generically
64-107 CEFACLOR LEDERLE CEFACLOR
27-APR-95 (CAPSULE) SANFORD, NC EQ 250MG BASE
27330 EQ 500MG BASE
(ANTIBIOTIC,
CEPHEM)
74-453 METOPROLOL TARTRATE PAR PHARM METOPROLOL TARTRATE
27-APR-95 (TABLET) SPRING VALLEY, NY 50MG
10977 100MG
(BETA ADRENERGIC
BLOCKER)
40-034 THEOPHYLLINE INWOOD THEOPHYLLINE
28-APR-95 (TABLET, NEW YORK, NY 450MG
EXTENDED RELEASE) 10022 (BRONCHODILATOR)
64-070 CEFACLOR ZENITH CEFACLOR
28-APR-95 (POWDER NORTHVALE, NJ EQ 375MG BASE/5ML
FOR RECONSTITUTION) 07647 (ANTIBIOTIC,
CEPHEM)
64-085 CEFACLOR ZENITH CEFACLOR
28-APR-95 (POWDER NORTHVALE, NJ EQ 250MG BASE/5ML
FOR RECONSTITUTION) 07647 (ANTIBIOTIC,
CEPHEM)
64-086 CEFACLOR ZENITH CEFACLOR
28-APR-95 (POWDER NORTHVALE, NJ EQ 187MG BASE/5ML
FOR RECONSTITUTION) 07647 (ANTIBIOTIC,
CEPHEM)
64-087 CEFACLOR ZENITH CEFACLOR
28-APR-95 (POWDER NORTHVALE, NJ EQ 125MG BASE/5ML
FOR RECONSTITUTION) 07647 (ANTIBIOTIC,
CEPHEM)
64-110 CEFACLOR LEDERLE CEFACLOR
28-APR-95 (POWDER SANFORD, NC EQ 375MG BASE/5ML
FOR RECONSTITUTION) 27330 (ANTIBIOTIC,
CEPHEM)
64-114 CEFACLOR LEDERLE CEFACLOR
28-APR-95 (POWDER SANFORD, NC EQ 125MG BASE/5ML
FOR RECONSTITUTION) 27330 (ANTIBIOTIC,
CEPHEM)
64-115 CEFACLOR LEDERLE CEFACLOR
28-APR-95 (POWDER SANFORD, NC EQ 187MG BASE/5ML
FOR RECONSTITUTION) 27330 (ANTIBIOTIC,
CEPHEM)
64-116 CEFACLOR LEDERLE CEFACLOR
28-APR-95 (POWDER SANFORD, NC EQ 250MG BASE/5ML
FOR RECONSTITUTION) 27330 (ANTIBIOTIC,
CEPHEM)
73-677 CARBASTAT CIBA CARBACHOL
28-APR-95 (SOLUTION) DULUTH, GA 0.01%
30136 (CHOLINERGIC)
74-081 METHADONE HCL ROXANE METHADONE
HYDROCHLORIDE
28-APR-95 (TABLET, COLUMBUS, OH 40MG
DISPERSIBLE) 43216 (NARCOTIC
ANALGESIC)
74-261* TIMOLOL MALEATE ALCON TIMOLOL MALEATE
28-APR-95 (SOLUTION/DROPS) FORT WORTH, TX EQ 0.25% BASE
76115 (BETA ADRENERGIC
BLOCKER)
74-262* TIMOLOL MALEATE ALCON TIMOLOL MALEATE
28-APR-95 (SOLUTION/DROPS) FORT WORTH, TX EQ 0.5% BASE
76134 (BETA ADRENERGIC
BLOCKER)
74-410 NAPROXEN MOVA NAPROXEN
28-APR-95 (TABLET) CAGUAS, PR 250MG
00725 375MG
500MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-442 GEMFIBROZIL CHELSEA LABS GEMFIBROZIL
28-APR-95 (TABLET) WEST HEMPSTEAD, NY 600MG
11552 (ANTIHYPERLIPIDEMIC)
* - 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.
74-481 CAPTOPRIL INVAMED CAPTOPRIL
28-APR-95 (TABLET) DAYTON, NJ 12.5MG
08810 25MG
50MG
100MG
(ANGIOTENSIN
CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
17-646 PERGONAL SERONO MENOTROPINS--
05-APR-95 (INJECTABLE) BRAINTREE, MA FOLLICLE
02184 STIMULATING HORMONE
75IU/AMP
LUTEINIZING HORMONE
75IU/AMP
(LABELING REVISION
--
ADVERSE REACTIONS)
17-646 PERGONAL SERONO MENOTROPINS--
05-APR-95 (INJECTABLE) BRAINTREE, MA FOLLICLE
02184 STIMULATING
HORMONE
150IU/AMP
LUTEINIZING HORMONE
150IU/AMP
(LABELING REVISION
--
ADVERSE REACTIONS)
19-107 PROTROPIN GENENTECH SOMATREM
05-APR-95 (INJECTABLE) S SAN FRANCISCO, CA 5MG/VIAL
94080 10MG/VIAL
(LABELING REVISION
--
DESCRIPTION;
CLINICAL
PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
10-496 XYLOCAINE 5% ASTRA LIDOCAINE
HYDROCHLORIDE
06-APR-95 W/GLUCOSE 7.5% WESTBOROUGH, MA 5%
(INJECTABLE) 01581 (LABELING REVISION
--
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
18-841 DAYPRO SEARLE OXAPROZIN
06-APR-95 (TABLET) SKOKIE, IL 600MG
60077 (LABELING REVISION
--
ADVERSE REACTIONS)
19-829 CERETEC AMERSHAM TECHNETIUM TC-99M
07-APR-95 (INJECTABLE) ARLINGTON HEIGHTS, IL EXAMETAZIME KIT
60005 N/A
(LABELING REVISION
--
DESCRIPTION;
CLINICAL
PHARMACOLOGY;
INDICATIONS AND
USAGE;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION;
RADIATION
DOSIMETRY)
20-103 ZOFRAN GLAXO ONDANSETRON
HYDROCHLORIDE
10-APR-95 (TABLET) RES TRIANGLE PK, NC EQ 4MG BASE
27709 EQ 8MG BASE
(LABELING REVISION
--
DOSAGE AND
ADMINISTRATION)
20-243 LUVOX SOLVAY FLUVOXAMINE MALEATE
12-APR-95 (TABLET) MARIETTA, GA 25MG*
30062 50MG
100MG
150MG*
(LABELING REVISION
--
WARNINGS;
PRECAUTIONS;
ADVERSE REACTIONS)
* Not Marketed At This Time
20-272 RISPERDAL JANSSEN RISPERIDONE
12-APR-95 (TABLET) TITUSVILLE, NJ 1MG
08560 2MG
3MG
4MG
(LABELING REVISION
--
PRECAUTIONS;
ADVERSE REACTIONS)
50-521 CECLOR ELI LILLY CEFACLOR
13-APR-95 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE
46285 EQ 500MG BASE
(LABELING REVISION
--
INDICATIONS AND
USAGE)
50-522 CECLOR ELI LILLY CEFACLOR
13-APR-95 (POWDER INDIANAPOLIS, IN EQ 125MG BASE/5ML
FOR RECONSTITUTION) 46285 EQ 250MG BASE/5ML
(LABELING REVISION
--
INDICATIONS AND
USAGE)
18-826 DOPAMINE HCL ABBOTT DOPAMINE
HYDROCHLORIDE
14-APR-95 IN DEXTROSE 5% ABBOTT PARK, IL 80MG/100ML
IN PLASTIC CONTAINER 60064 160MG/100ML
(INJECTABLE) 320MG/100ML
(LABELING REVISION
--
CONTRAINDICATIONS;
WARNINGS;
PRECAUTIONS;
ADVERSE REACTIONS;
HOW SUPPLIED)
19-766 ZOCOR MERCK SIMVASTATIN
19-APR-95 (TABLET) WEST POINT, PA 5MG
19486 10MG
20MG
40MG
(LABELING REVISION
--
CLINICAL
PHARMACOLOGY;
ADVERSE REACTIONS)
20-103 ZOFRAN GLAXO ONDANSETRON
HYDROCHLORIDE
19-APR-95 (TABLET) RES TRIANGLE PK, NC EQ 4MG BASE
27709 EQ 8MG BASE
(LABELING REVISION
--
CLINICAL
PHARMACOLOGY;
INDICATIONS AND
USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
18-580 YUTOPAR ASTRA RITODRINE
HYDROCHLORIDE
20-APR-95 (INJECTABLE) WESTBOROUGH, MA 10MG/ML
01581 15MG/ML
(LABELING REVISION
--
DESCRIPTION;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
18-938 DDAVP RHONE POULENC RORER DESMOPRESSIN
ACETATE
25-APR-95 (INJECTABLE) COLLEGEVILLE, PA 0.015MG/ML
19426 (LABELING REVISION
--
NEW LABEL FOR NEW
POTENCY)
09-218 COUMADIN DUPONT MERCK WARFARIN SODIUM
28-APR-95 (TABLET) WILMINGTON, DE 1MG
19880 2MG
2.5MG
4MG
5MG
7.5MG
10MG
(LABELING REVISION
--
CLINICAL
PHARMACOLOGY;
INDICATIONS AND
USAGE;
DOSAGE AND
LABORATORY USAGE)
20-071 DESOGEN ORGANON DESOGESTREL
28-APR-95 (TABLET-21 DAY) WEST ORANGE, NJ 0.15MG
07052 ETHINYL ESTRADIOL
0.03MG
(LABELING REVISION
--
INDICATIONS AND
USAGE)
20-071 DESOGEN ORGANON DESOGESTREL
28-APR-95 (TABLET-28 DAY) WEST ORANGE, NJ 0.15MG
07052 ETHINYL ESTRADIOL
0.03MG
(LABELING REVISION
--
INDICATIONS AND
USAGE)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
1183 NONE PSL HLTHCARE SYS PLASMA
04-APR-95 (INJECTABLE) DENVER, CO (A,B)
80218
1183 NONE PSL HLTHCARE SYS RED BLOOD CELLS
04-APR-95 (INJECTABLE) DENVER, CO (A,B)
80218
1183 NONE PSL HLTHCARE SYS WHOLE BLOOD
04-APR-95 (INJECTABLE) DENVER, CO (A,B)
80218
0428 NONE COMM BLOOD COUNCIL SOURCE LEUKOCYTES
05-APR-95 (INJECTABLE) MERCER CNTY (B)
TRENTON, NJ
08638
0602 NONE CENTRAL JERSEY BLOOD CTR SOURCE LEUKOCYTES
05-APR-95 (INJECTABLE) SHREWSBURY, NJ (B)
07702
1127 NONE HUNTER BLOOD CTR SOURCE LEUKOCYTES
06-APR-95 (INJECTABLE) CLEARWATER, FL (B)
34616
0197 NONE BLOOD BANK REDWOODS PLATELETS
07-APR-95 (INJECTABLE) SANTA ROSA, CA (B)
95405
0428 NONE COMM BLOOD COUNCIL PLATELETS
13-APR-95 (INJECTABLE) MERCER CNTY (B)
TRENTON, NJ
08638
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950014 SEG-SAFE ALPHA SCI SEGMENT DISPENSER
01-APR-95 SOUTHEASTERN, PA (C)
19399
BK930002 NONE NOR LAKE SCI BLOOD BANK
REFRIGERATOR
13-APR-95 HUDSON, WI (C)
54016
BK930003 NONE NOR LAKE SCI BLOOD BANK
REFRIGERATOR
13-APR-95 HUDSON, WI (C)
54016
BK930004 NONE NOR LAKE SCI PLASMA FREEZER
13-APR-95 HUDSON, WI (C)
54016
BK930005 NONE NOR LAKE SCI PLASMA FREEZER
13-APR-95 HUDSON, WI (C)
54016
BK930006 NONE NOR LAKE SCI PLASMA FREEZER
13-APR-95 HUDSON, WI (C)
54016
BK950019 NONE DUPACO DUPACO BLOOD/FLUID
27-APR-95 OCEANSIDE, CA WARMING SET D25416
92056 (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
P940033 FEMIDOM FEMALE CHARTEX INTERNATIONAL PLC FOR USE TO HELP
04/14/95 CONDOM LINCOLNSHIRE, IL PREVENT PREGNANCY AND
60069-3405 SEXUALLY TRANSMITTED
DISEASES, INCLUDING
HIV DURING VAGINAL
INTERCOURSE
***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
N17679/S30 PREFERENCE, COOPERVISION, INC. ADD THE MONOVISION
04/17/95 COOPERCLEAR FW, FAIRPORT, NY FITTING TECHNIQUE TO
VANTAGETHIN, 14450 THE LABELING OF A
VANTAGETHIN ACCENTS SINGLE VISION
HYDROPHILIC LENSES CONTACT LENS TO
MANAGE
PRESBYOPIA
N50510/S67 VITEK GENERAL BIOMERIEUX VITEK, INC. LIMITATION STATEMENT
04/19/95 SUSCEPTIBILITY CARD HAZELWOOD, MO CONTRAINDICATING THE
63042-2395 TESTING OF AEROMONAS
SP. WITH AMPICILLIN,
AMPICILLIN/SULBACTAM,
CEFOTETAN, CEFOXITIN,
CEFUROXIME, ETC.
P790005/S37 ORTHOGEN/OSTEOGEN ELECTRO-BIOLOGY, INC. CHANGE TO THE
04/06/95 IMPLANTABLE BONE PARSIPPANY, NJ STERILIZATION PROCESS
GROWTH STIMULATOR 07054-1079
AND SPF SPINAL
FUSION STIMULATOR
P790020/S56 PERMAFLEX COOPERVISION, INC. ADD THE MONOVISION
04/17/95 NATURALS, FAIRPORT, NY FITTING TECHNIQUE TO
PERMAFLEX UV 14450 THE LABELING OF A
NATURALS SINGLE VISION CONTACT
HYDROPHILIC LENS TO MANAGE
CONTACT LENSES PRESBYOPIA
P800022/S35 ZYDERM COLLAGEN COLLAGEN CORPORATION APPROVAL FOR THE
04/17/95 IMPLANT PALO ALTO, CA PROMOTIONAL
94303 LITERATURE THAT WILL
ACCOMPANY ZYDERM I
WITH FINE GAUGE NEEDLE
P800022/S47 ADG NEEDLE COLLAGEN CORPORATION CHANGES TO THE
04/26/95 PALO ALTO, CA INSTRUCTIONS FOR USE
94303 FOR THE ADG NEEDLE TO
PREVENT NEEDLE STICKS
P810040/S07 SUPERSTAT SUPERSTAT, INC. RELOCATION OF THE
04/21/95 MODIFIED COLLAGEN BONITA SPRINGS, FL MANUFACTURING
HEMOSTATIC SPONGES 33923 FACILITY
(BIOCELL LABORATORIES)
TO RANCHO DOMINGUEZ,
CALIFORNIA
P830055/S38 NEW JERSEY LCS DEPUY, INC. ADDITION OF ONE
04/05/95 TOTAL KNEE SYSTEM WARSAW, IN PIECE, POLYETHYLENE,
46581-0988 FIXED BEARING,
POSTERIOR CRUCIATE
RETAINING TIBIAL
COMPONENT
P830060/S36 VENTAK AICD CARDIAC PACEMAKERS, INC. ALTERNATE
04/13/95 SYSTEM ST. PAUL, MN STERILIZATION PROCESS
55112-5798
P830060/S37 VENTAK AICD CARDIAC PACEMAKERS, INC. ALTERNATE
04/13/95 SYSTEM ST. PAUL, MN STERILIZATION PROCESS
55112-5798
P840001/S34 MEDTRONIC ITREL MEDTRONIC NEUROLOGICAL SUBSTITUTION OF A
04/27/95 AND ITREL II MINNEAPOLIS, MN MATERIAL USED IN THE
SPINAL CORD 55440-9087 CONNECTOR MODULE OF
STIMULATION SEVERAL
SYSTEM CONNECTOR PULSE GENERATORS
MODULE
P840008/S45 DORNIER MFL5000 DORNIER MEDICAL EXPANSION OF THE
04/12/95 LITHOTRIPTER SYSTEMS, INC INDICATION RANGE TO
KENNESAW, GA INCLUDE FRAGMENTATION
30144 OF MIDDLE AND LOWER
URETHRAL STONES
4 TO 9MM IN SIZE
P840024/S53 NUCLEUS COCHLEAR CORPORATION USE OF ALTERNATIVE
04/17/95 22-CHANNEL ENGLEWOOD, CO HEADSET CABLES
COCHLEAR IMPLANT 80112
SYSTEM
P840064/S12 VISCOAT AND ALCON LABORATORIES, INC. MODIFIED TEST REGIMEN
04/18/95 PROVISC FORT WORTH, TX FOR FINISHED DEVICES
76134-2099
P840068/S23 DELTA VISTA AND CARDIAC PACEMAKERS, INC. ALTERNATE
04/13/95 VIGOR SSI/DDD ST. PAUL, MN STERILIZATION
PACEMAKER SYSTEMS 55112-5798 PROCESS
P850035/S16 ORTHOGEN/OSTEOGEN ELECTRO-BIOLOGY, INC. CHANGE TO THE
04/06/95 IMPLANTABLE BONE PARSIPPANY, NJ STERILIZATION PROCESS
GROWTH STIMULATOR 07054-1079
AND SPF SPINAL
FUSION STIMULATOR
P850077/S19 SUNSOFT SUNSOFT CORPORATION PARAMETRIC RELEASE OF
04/28/95 (METHAFILCON A) ALBUQUERQUE, NM STERILIZED METHAFILCON A
SOFT (HYDROPHILIC) 87109 CONTACT LENSES
APPROVED
CONTACT LENSES AND LABELED FOR
EXTENDED WEAR
P870025/S02 COROMETRICS COROMETRICS MEDICAL LABELING CHANGE TO
04/12/95 MODEL 146 FETAL SYSTEMS, INC. PERMIT INTERFACE OF
ACOUSTIC STIMULATOR WALLINGFORD, CT THE COROMETRICS
06492-0333 MODEL 146 FETAL ACOUSTIC
STIMULATOR WITH
MODELS 116, 150, 118
AND 151 FETAL MONITORS
P870025/S03 COROMETRICS COROMETRICS MEDICAL LABELING CHANGE TO
04/12/95 MODEL 146 FETAL SYSTEMS, INC. PERMIT INTERFACE OF
ACOUSTIC STIMULATOR WALLINGFORD, CT THE COROMETRICS
06492-0333 MODEL 146 FETAL ACOUSTIC
STIMULATOR WITH
MODELS 116, 150, 118
AND 151 FETAL MONITORS
P870036/S32 EVERGREEN 40 MEDTRONIC INTERVENTION A 40 MM LONG BALLOON
04/27/95 CORONARY BALLOON VASCULAR VERSION OF THE EVERGREEN
DILATATION CATHETER SAN DIEGO, CA PTCA CATHETER AND
92121-2256 ALTERNATE STRAIN RELIEF
ASSEMBLY
P870036/S35 MEDTRONIC 18K, 14K, MEDTRONIC INTERVENTION REVISED LABELING
04/27/95 EVERGREEN, FALCON, VASCULAR
PANTHER, AND SPIRIT SAN DIEGO, CA
PTCA DILATATION 92121-2256
CATHETER
P880003/S36 CORDIS TITAN 18 CORDIS CORPORATION REVISED LABELING
04/27/95 PTCA DILATATION MIAMI, FL
CATHETER 33102-5700
P880003/S37 CORDIS OLYMPIX II CORDIS CORPORATION REVISED LABELING
04/27/95 PTCA DILATATION MIAMI, FL
CATHETER 33102-5700
P880003/S38 CORDIS PREDATOR XL CORDIS CORPORATION REVISED LABELING
04/27/95 PTCA DILATATION MIAMI, FL
CATHETER 33102-5700
P880003/S39 CORDIS EUROPASS CORDIS CORPORATION REVISED LABELING
04/27/95 PTCA DILATATION MIAMI, FL
CATHETER 33102-5700
P880003/S40 CORDIS TRAKSTAR CORDIS CORPORATION REVISED LABELING
04/27/95 18 PTCA DILATATION MIAMI, FL
CATHETER 33102-5700
P880091/S02 ELASTIC LENS STARR SURGICAL COMPANY ELASTIC LENS MODEL
04/03/95 MODEL AA-4203V FOR SOFTLENSCO, INC. AA-4203V
ULTRAVIOLET- MONROVIA, CA ULTRAVIOLET-ABSORBING
ABSORBING 91016 IOL; CHIRON VISION
POSTERIOR CHAMBER CORPORATION TO
INTRAOCULAR LENS DISTRIBUTE AS THE
CHIROFLEX
MODEL 32-C10UB IOL
P890001/S12 LEOCOR PICO LEOCOR, INC. REVISED LABELING
04/27/95 RUNNER PTCA CATHETER HOUSTON, TX
77058
P890032/S20 CORDIS ORION AND CORDIS CORPORATION REVISED LABELING
04/27/95 3.5 MM ORION MIAMI, FL
STEERABLE PTCA 33102-5700
BALLOON CATHETERS
P890045/S05 VASCUTEK GELSEAL CARBOMEDICS, INC. LABELING CHANGE TO
04/13/95 VASCULAR GRAFT AUSTIN, TX ADD A STATEMENT
78752 RELATING TO BOVINE
SPONGIOFORM
ENCEPHALOPATHY
P890047/S05 MODIFIED TEST ALCON LABORATORIES, INC. MODIFIED TEST REGIMEN
04/18/95 REGIMEN FOR THE FORT WORTH, TX FOR FINISHED DEVICES
RELEASE OF VISCOAT 76134-2099
AND PROVISC
P890061/S09 VENTAK P AICD CARDIAC PACEMAKERS, INC. ALTERNATE
04/11/95 SYSTEM ST. PAUL, MN STERILIZATION PROCESS
55112-5798
P890064/S03 VIRATYPE HUMAN DIGENE DIAGNOSTICS, INC. RNA:DNA SANDWICH
04/28/95 PAPILLOMAVIRUS SILVER SPRING, MD CAPTURE (ANTIBODY)
(HPV) DNA TYPING 20904 ENZYMATIC
KIT CHEMILUMINESCENT
MOLECULAR
HYBRIDIZATION ASSAY
WITH THE NEW TRADE
NAME HYBRID CAPTURE
P900056/S10 ROTABLATOR HEART TECHNOLOGY PACKAGING INSERT FOR
04/27/95 ROTATIONAL REDMOND, WA THE A AND C TYPE
ANGIOPLASTY SYSTEM 98052 GUIDEWIRES
P900061/S10 MEDTRONIC MEDTRONIC, INC. LABELING CHANGES
04/27/95 IMPLANTABLE MINNEAPOLIS, MN REGARDING CELLULAR
CARDIOVERTER 55432-3576 PHONES
DEFIBRILLATORS
MODEL: 7217B/D-PCD,
7201B/D-PCD CD,
7219B/D/E-JEWEL,
7202D/E-JEWEL CD
P910020/S08 RELAY MODELS INTERMEDICS, INC. CHANGE IN THE
04/27/95 294-03/293-03, ANGLETON, TX MANUFACTURE OF THE
DASH MODELS 77515 MICROELECTRONIC
291-03/292-03/ HYBRIDS
292-03R, STRIDE
MODEL 294-05,
AND DART
MODEL 292-05
P910023/S10 CADENCE TIERED VENTRITEX, INC. LABELING CHANGES IN
04/27/95 THERAPY SUNNYVALE, CA THE PATIENT MANUAL
DEFIBRILLATOR SYSTEM 94086-6527
P910073/S03 ENDOTAK SQ LEAD CARDIAC PACEMAKERS, INC. ENDOTAK SQ LEAD ARRAY
04/17/95 ARRAY MODEL 0048 ST. PAUL, MN MODEL 0048 AND
55112-5798 ACCESSORY KIT MODEL 6927
P910073/S08 ENDOTAK CARDIAC PACEMAKERS, INC. ALTERNATE
04/13/95 TRANSVENOUS ST. PAUL, MN STERILIZATION PROCESS
DEFIBRILLATION 55112-5798
LEAD SYSTEM
P910073/S10 ENDOTAK CARDIAC PACEMAKERS, INC. ALTERNATE
04/13/95 TRANVENOUS ST. PAUL, MN MANUFACTURING
DEFIBRILLATION 55112-5798 STERILIZATION PROCESS
LEAD SYSTEM
P910073/S11 ENDOTAK C 0060 CARDIAC PACEMAKERS, INC. DESIGN CHANGES TO THE
04/27/95 AND 0070 SERIES ST. PAUL, MN ENDOTAK C 0060 AND
LEADS 55112-5798 0070 SERIES LEADS
P910075/S01 WESLEY-JESSEN ALLERGAN OPTICAL CHANGE THE MAXIMUM
04/28/95 MULTI-PURPOSE IRVINE, CA RECOMMENDED STORAGE
SOLUTION 92713-9534 TIME ON THE LABEL
FROM 7 DAYS TO 30
FOR THE LENS WEARER'S
STORAGE OF LENSES
P910077/S06 VENTAK PRX AICD CARDIAC PACEMAKERS, INC. ALTERNATE
04/13/95 SYSTEM ST. PAUL, MN STERILIZATION PROCESS
55112-5798
P940013/S04 PRECISION UV PILKINGTON BARNES-HIND LABELING CHANGES TO
04/19/95 (VASURFILCON) SOFT SUNNYVALE, CA INCLUDE DISPOSABLE
(HYDROPHILIC) 94086-5200 WEARING INSTRUCTIONS
CONTACT LENSES
(CLEAR AND TINTED)
***ORIGINAL VETERINARY NADAs***
141-026 PROGRAM CATS CIBA AN HLTH LUFENURON
03-28-95 (SUSPENSION) GREENSBORO, NC 135MG/PACKET
27419 270MG/PACKET
***ORIGINAL ABBREVIATED VETERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR APRIL 1995.
***SUPPLEMENTAL VETERINARY NADAs***
THE ARE NO SUPPLEMENTAL VETERINARY NADAs FOR APRIL 1995.
Date created: August 2, 1996; last updated: June 20, 2005 |
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