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Drug and Device Product Approvals for January 1995
***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
20-403 ZOFRAN GLAXO ONDANSETRON HYDROCHLORIDE
31-JAN-95 IN PLASTIC CONTAINER RES TRIANGLE PK, NC EQ 0.64MG BASE/ML
(3 S) (INJECTABLE) 27709 (ANTIEMETIC)
***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.
50-703 BACTROBAN SMITHKLINE BEECHAM MUP
IROCIN CALCIUM
20-JAN-95 (OINTMENT) KING OF PRUSSIA, PA EQ 2% BASE
19406 (ANTIBACTERIAL)
50-710 ZITHROMAX PFIZER AZITHROMYCIN DIHYDRATE
27-JAN-95 (POWDER, GROTON, CT EQ 100MG BASE/5ML
FOR RECONSTITUTION) 06340 EQ 200MG BASE/5ML
EQ 1GM/PACKET
(ANTIBIOTIC, MACROLIDE)
***ORIGINAL ABBREVIATED NDAs***
73-580* MEBENDAZOLE COPLEY PHARM MEBENDAZOLE
04-JAN-95 (TABLET, CHEWABLE) CANTON, MA 100MG
02021 (ANTHELMINTIC)
74-136 MICONAZOLE NITRATE LEMMON MICONAZOLE NITRATE
04-JAN-95 (CREAM) SELLERSVILLE, PA 2%
18960 (ANTIFUNGAL)
(OTC)
74-447* FLURBIPROFEN SODIUM BAUSCH AND LOMB FLURBIPROFEN SODIUM
04-JAN-95 (SOLUTION/DROPS) TAMPA, FL 0.03%
33637 (NONSTEROIDAL
ANTI-INFLAMMATORY)
89-822 UNI-DUR KEY PHARMS THEOPHYLLINE
04-JAN-95 (TABLET, KENILWORTH, NJ 400MG
EXTENDED RELEASE) 07033 (BRONCHODILATOR)
89-823* UNI-DUR KEY PHARMS THEOPHYLLINE
04-JAN-95 (TABLET, KENILWORTH, NJ 600MG
EXTENDED RELEASE) 07033 (BRONCHODILATOR)
89-932 THEOPHYLLINE FAULDING THEOPHYLLINE
04-JAN-95 (CAPSULE, SALISBURY, S AUSTRALIA 300MG
EXTENDED RELEASE) (BRONCHODILATOR)
89-976 THEOPHYLLINE FAULDING THEOPHYLLINE
04-JAN-95 (CAPSULE, SALISBURY, S AUSTRALIA 100MG
EXTENDED RELEASE) (BRONCHODILATOR)
89-977 THEOPHYLLINE FAULDING THEOPHYLLINE
04-JAN-95 (CAPSULE, SALISBURY, S AUSTRALIA 200MG
EXTENDED RELEASE) (BRONCHODILATOR)
74-060 VALPROIC ACID HIGH TECH PHARMACAL VALPROIC ACID
13-JAN-95 (SYRUP) AMITYVILLE, NY 250MG/5ML
11701 (ANTICONVULSANT)
* - First Time Product Available Generically
74-056 ATENOLOL LEMMON ATENOLOL
18-JAN-95 (TABLET) SELLERSVILLE, PA 50MG
18960 100MG
(BETA ADRENERGIC BLOCKER)
74-336 NITROFURANTOIN GENEVA PHARMS NITROFURANTOIN,
25-JAN-95 (CAPSULE) BROOMFIELD, CO MACROCRYSTALLINE
80038 25MG
50MG
100MG
(ANTIBACTERIAL)
64-046 BACITRACIN ZINC AND BAUSCH AND LOMB BACITRACIN ZINC
26-JAN-95 POLYMYXIN B SULFATE TAMPA, FL 500 UNITS/GM
(OINTMENT) 33637 POLYMYXIN B SULFATE
10,000 UNITS/GM
(ANTIBIOTIC, PEPTIDE)
74-441 BUMETANIDE BEDFORD BUMETANIDE
27-JAN-95 (INJECTABLE) BEDFORD, OH 0.25MG/ML
44146 (LOOP DIURETIC)
64-028 BACITRACIN ZINC AND ADV REMEDIES BACITRACIN ZINC
30-JAN-95 POLYMYXIN B SULFATE SOMERSET, NJ 500 UNITS/GM
(OINTMENT) 08873 POLYMYXIN B SULFATE
10,000 UNITS/GM
(ANTIBIOTIC, PEPTIDE)
74-193* HETASTARCH 6% IN ABBOTT HETASTARCH
30-JAN-95 SODIUM CHLORIDE 0.9% ABBOTT PARK, IL 6GM/100ML
IN PLASTIC CONTAINER 60064 (PLASMA VOLUME EXPANDER)
(INJECTABLE)
74-443* CROLOM BAUSCH AND LOMB CROMOLYN SODIUM
30-JAN-95 (SOLUTION/DROPS) TAMPA, FL 4%
33637 (ASTHMA PROPHYLACTIC)
* - First Time Product Available Generically
74-100 CIMETIDINE GENEVA PHARMS CIMETIDINE
31-JAN-94 (TABLET) BROOMFIELD, CO 200MG
80038 300MG
400MG
800MG
(HISTAMINE H2-RECEPTOR
ANTAGONIST)
74-141 METOPROLOL TARTRATE LEMMON METOPROLOL TARTRATE
31-JAN-95 (TABLET) SELLERSVILLE, PA 50MG
18960 100MG
(BETA ADRENERGIC BLOCKER)
74-344 CIMETIDINE HCL ABBOTT CIMETIDINE HYDROCHLORIDE
31-JAN-95 (INJECTABLE) ABBOTT PARK, IL EQ 300MG BASE/2ML
[SINGLE DOSE, 60064 (HISTAMINE H2-RECEPTOR
PRESERVATIVE FREE] ANTAGONIST)
74-345 CIMETIDINE HCL ABBOTT CIMETIDINE HYDROCHLORIDE
31-JAN-95 (INJECTABLE) ABBOTT PARK
, IL EQ 300MG BASE/2ML
[MULTIPLE DOSE] 60064 (HISTAMINE H2-RECEPTOR
ANTAGONIST)
74-422 CIMETIDINE HCL ABBOTT CIMETIDINE HYDROCHLORIDE
31-JAN-95 (INJECTABLE) ABBOTT PARK, IL EQ 300MG BASE/2ML
[ADD-VANTAGE, 60064 (HISTAMINE H2-RECEPTOR
PRESERVATIVE FREE] ANTAGONIST)
81-145 METHOCARBAMOL STEVENS J ASPIRIN
31-JAN-95 AND ASPIRIN BOHEMIA, NY 325MG
(TABLET) 11716 (ANALGESIC)
METHOCARBAMOL
400MG
(SKELETAL MUSCLE RELAXANT)
***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.
74-124 CIPROFLOXACIN BARR CIPROFLOXACIN
04-JAN-95 (TABLET) POMONA, NY 250MG
10970 500MG
750MG
(ANTIBACTERIAL, QUINOLONE)
74-363 CAPTOPRIL GENEVA CAPTOPRIL
30-JAN-95 (TABLET) BROOMFIELD, CO 12.5MG
80038 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
17-521 DEXTROSE 10% BAXTER HLTHCARE DEXTROSE
05-JAN-95 IN PLASTIC CONTAINER ROUND LAKE, IL 10GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
DESCRIPTION;
PRECAUTIONS)
17-521 DEXTROSE 20% BAXTER HLTHCARE DEXTROSE
05-JAN-95 IN PLASTIC CONTAINER ROUND LAKE, IL 20GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
DESCRIPTION;
PRECAUTIONS)
17-521 DEXTROSE 30% BAXTER HLTHCARE DEXTROSE
05-JAN-95 IN PLASTIC CONTAINER ROUND LAKE, IL 30GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
DESCRIPTION;
PRECAUTIONS)
17-521 DEXTROSE 40% BAXTER HLTHCARE DEXTROSE
05-JAN-95 IN PLASTIC CONTAINER ROUND LAKE, IL 40GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
DESCRIPTION;
PRECAUTIONS)
17-521 DEXTROSE 50% BAXTER HLTHCARE DEXTROSE
05-JAN-95 IN PLASTIC CONTAINER ROUND LAKE, IL 50GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
DESCRIPTION;
PRECAUTIONS)
17-521 DEXTROSE 60% BAXTER HLTHCARE DEXTROSE
05-JAN-95 IN PLASTIC CONTAINER ROUND LAKE, IL 60GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
DESCRIPTION;
PRECAUTIONS)
17-521 DEXTROSE 70% BAXTER HLTHCARE DEXTROSE
05-JAN-95 IN PLASTIC CONTAINER ROUND LAKE, IL 70GM/100ML
(INJECTABLE) 60073 (LABELING REVISION --
DESCRIPTION;
PRECAUTIONS)
20-208 METROGEL CURATEK METRONIDAZOLE
06-JAN-95 (GEL) ELK GROVE VILLAGE, IL 0.75%
60007 (LABELING REVISION --
DIRECTIONS FOR USE)
50-542 AMOXIL SMITHKLINE BEECHAM AMOXICILLIN
10-JAN-95 (TABLET, CHEWABLE) PHILADELPHIA, PA 125MG
19101 250MG
(LABELING REVISION --
ADVERSE REACTIONS)
12-093 ISORDIL WYETH AYERST ISOSORBIDE DINITRATE
11-JAN-95 (TABLET) PHILADELPHIA, PA 5MG
19101 10MG
20MG
30MG
40MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
12-882 ISORDIL WYETH AYERST ISOSORBIDE DINITRATE
11-JAN-95 (CAPSULE, PHILADELPHIA, PA 40MG
EXTENDED RELEASE) 19101 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
12-940 ISORDIL WYETH AYERST ISOSORBIDE DINITRATE
11-JAN-95 (TABLET, SUBLINGUAL) PHILADELPHIA, PA 2.5MG
19101 5MG
10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
18-705 NITROLINGUAL BOSKAMP NITROGLYCERIN
11-JAN-95 (AEROSOL) HOHENLOCKSTEDT 0.4MG/SPRAY
WESTBREITE STRASSE (LABELING REVISION --
GERMANY PRECAUTIONS)
18-686 NORMODYNE SCHERING LABETALOL HYDROCHLORIDE
12-JAN-95 (INJECTABLE) KENILWORTH, NJ 5MG/ML
07033 (LABELING REVISION --
PRECAUTIONS)
19-787 NORVASC PFIZER AMLODIPINE BESYLATE
12-JAN-95 (TABLET) NEW YORK, NY EQ 2.5MG BASE
10017 EQ 5MG BASE
EQ 10MG BASE
(LABELING REVISION --
ADVERSE REACTIONS)
13-295 CONRAY MALLINCKRODT MEDICAL IOTHALAMATE MEGLUMINE
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 60%
63134 (LABELING REVISION --
BOXED WARNING)
13-295 CONRAY 43 MALLINCKRODT MEDICAL IOTHALAMATE MEGLUMINE
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 43%
63134 (LABELING REVISION --
BOXED WARNING)
14-295 CONRAY 400 MALLINCKRODT MEDICAL IOTHALAMATE SODIUM
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 66.8%
63134 (LABELING REVISION --
BOXED WARNING)
16-783 VASCORAY MALLINCKRODT MEDICAL IOTHALAMATE MEGLUMINE
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 52%
63134 IOTHALAMATE SODIUM
26%
(LABELING REVISION --
BOXED WARNING)
16-983 CONRAY 30 MALLINCKRODT MEDICAL IOTHALAMATE MEGLUMINE
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 30%
63134 (LABELING REVISION --
BOXED WARNING)
17-057 CYSTO-CONRAY MALLINCKRODT MEDICAL IOTHALAMATE MEGLUMINE
13-JAN-95 (SOLUTION) SAINT LOUIS, MO 43%
63134 (LABELING REVISION --
BOXED WARNING)
17-057 CYSTO-CONRAY II MALLINCKRODT MEDICAL IOTHALAMATE MEGLUMINE
13-JAN-95 (SOLUTION) SAINT LOUIS, MO 17.2%
63134 (LABELING REVISION --
BOXED WARNING)
17-685 CONRAY 325 MALLINCKRODT MEDICAL IOTHALAMATE SODIUM
13-JAN-95 (INJECTABLE) SAINT LOUIS,
MO 54.3%
63134 (LABELING REVISION --
BOXED WARNING)
18-905 HEXABRIX MALLINCKRODT MEDICAL IOXAGLATE MEGLUMINE
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 39.3%
63134 IOXAGLATE SODIUM
19.6%
(LABELING REVISION --
BOXED WARNING)
19-292 MD-76 MALLINCKRODT MEDICAL DIATRIZOATE MEGLUMINE
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 66%
63134 DIATRIZOATE SODIUM
10%
(LABELING REVISION -- BOXED WARNING)
19-710 OPTIRAY 160 MALLINCKRODT MEDICAL IOVERSOL
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 34%
63134 (LABELING REVISION --
BOXED WARNING)
19-710 OPTIRAY 240 MALLINCKRODT MEDICAL IOVERSOL
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 51%
63134 (LABELING REVISION --
BOXED WARNING)
19-710 OPTIRAY 300 MALLINCKRODT MEDICAL IOVERSOL
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 64%
63134 (LABELING REVISION --
BOXED WARNING)
19-710 OPTIRAY 320 MALLINCKRODT MEDICAL IOVERSOL
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 68%
63134 (LABELING REVISION --
BOXED WARNING)
19-710 OPTIRAY 350 MALLINCKRODT MEDICAL IOVERSOL
13-JAN-95 (INJECTABLE) SAINT LOUIS, MO 74%
63134 (LABELING REVISION --
BOXED WARNING)
08-173 BENOQUIN ICN MONOBENZONE
17-JAN-95 (CREAM) COSTA MESA, CA 20%
92626 (LABELING REVISION --
LABELING FORMAT
REVISION PROGRAM)
19-463 TIMOPTIC MERCK TIMOLOL MALEATE
18-JAN-95 IN OCUDOSE WEST POINT, PA EQ 0.25% BASE
(SOLUTION/DROPS) 19486 EQ 0.5% BASE
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE)
20-304 TRASYLOL MILES PHARM APROTININ BOVINE
19-JAN-95 (INJECTABLE) WEST HAVEN, CT 10,000 KIU/ML
06516 (LABELING REVISION --
WARNINGS; P
RECAUTIONS;
ADVERSE REACTIONS)
19-661 CYTOVENE SYNTEX GANCICLOVIR SODIUM
20-JAN-95 (INJECTABLE) PALO ALTO, CA EQ 500MG BASE/VIAL
94304 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION)
19-643 MEVACOR MERCK LOVASTATIN
23-JAN-95 (TABLET) WEST POINT, PA 10MG
19486 20MG
40MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; PRECAUTIONS)
19-766 ZOCOR MERCK SIMVASTATIN
23-JAN-95 (TABLET) WEST POINT, PA 5MG
19486 10MG
20MG
40MG
(LABELING REVISION --
WARNINGS; PRECAUTIONS)
17-576 OVCON-50 BRISTOL MYERS SQUIBB ETHINYL ESTRADIOL
25-JAN-95 (TABLET-21 DAY) PRINCETON, NJ 0.05MG
08543 NORETHINDRONE
1MG
(LABELING REVISION --
STD STATEMENT;
INDICATIONS AND USAGE;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
PATIENT PACKAGE INSERT)
17-716 OVCON-35 BRISTOL MYERS SQUIBB ETHINYL ESTRADIOL
25-JAN-95 (TABLET-28 DAY) PRINCETON, NJ 0.035MG
08543 NORETHINDRONE
0.4MG
(LABELING REVISION --
STD STATEMENT;
INDICATIONS AND USA
GE;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
PATIENT PACKAGE INSERT)
18-127 OVCON-35 BRISTOL MYERS SQUIBB ETHINYL ESTRADIOL
25-JAN-95 (TABLET-21 DAY) PRINCETON, NJ 0.035MG
08543 NORETHINDRONE
0.4MG
(LABELING REVISION --
STD STATEMENT;
INDICATIONS AND USAGE;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
PATIENT PACKAGE INSERT)
18-128 OVCON-50
BRISTOL MYERS SQUIBB ETHINYL ESTRADIOL
25-JAN-95 (TABLET-21 DAY) PRINCETON, NJ 0.05MG
08543 NORETHINDRONE
1MG
(LABELING REVISION --
STD STATEMENT;
INDICATIONS AND USAGE;
PRECAUTIONS;
DOSAGE AND ADMINISTRATION;
PATIENT PACKAGE INSERT)
18-685 GAVISCON MARION MERRELL DOW ALUMINUM HYDROXIDE
25-JAN-95 (TABLET, CHEWABLE) KANSAS CITY, MO 80MG
64134 MAGNESIUM TRISILICATE
20MG
(LABELING REVISION --
PATIENT LABELING)
(OTC)
18-685 GAVISCON-2 MARION MERRELL DOW ALUMINUM HYDROXIDE
25-JAN-95 (TABLET, CHEWABLE) KANSAS CITY, MO 160MG
64134 MAGNESIUM TRISILICATE
40MG
(LABELING REVISION --
PATIENT LABELING)
(OTC)
19-979 TICLID SYNTEX TICLOPIDINE HYDROCHLORIDE
25-JAN-95 (TABLET) PALO ALTO, CA 250MG
94304 (LABELING REVISION --
ADVERSE
REACTIONS;
PATIENT INFORMATION)
03-158 ORETON METHYL SCHERING METHYLTESTOSTERONE
26-JAN-95 (TABLET) KENILWORTH, NJ 10MG
07033 (LABELING REVISION --
WARNINGS; PRECAUTIONS;
HOW SUPPLIED)
16-273 LASIX HOECHST ROUSSEL FUROSEMIDE
26-JAN-95 (TABLET) SOMERVILLE, NJ 20MG
08876 40MG
80MG
(LABELING REVISION --
PRECAUTIONS)
16-363 LASIX HOECHST ROUSSEL FUROSEMIDE
26-JAN-95 (INJECTABLE) SOMERVILLE, NJ 10MG/ML
08876 (LABELING REVISION --
PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
17-688 LASIX HOECHST ROUSSEL FUROSEMIDE
26-JAN-95 (SOLUTION) SOMERVILLE, NJ 10MG/ML
08876 (LABELING REVISION --
PRECAUTIONS)
20-144* TRANSDERM-NITRO CIBA GEIGY NITROGLYCERIN
26-JAN-95 (FILM, SUMMIT, NJ 2.5MG/24HR
EXTENDED RELEASE) 07901 5MG/24HR
10MG/24HR
15MG/24HR
20MG/24HR
(LABELING REVISION --
PRECAUTIONS)
* - Permitted
***BIOLOGICAL PRODUCT LICENSES ISSUED***
THERE ARE NO BIOLOGICAL PRODUCT LICENSES ISSUED FOR JANUARY 1995.
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK940010 CAPTIA MERCIA DIAG LTD TREPONEMAL TEST FOR SYPHILLIS
03-JAN-95 SHAFORD, GUILDFORD (C)
UNITED KINGDOM
GU4 8EW
BK940061 COMPOSEAL MOBILEA NPBI BLOOD TUBE SEALERS
26-JAN-95 COMPOSEAL EMMRI COMPASCUUM, (C)
UNIVERSAL NEDERLAND 7881 HM
(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
THERE ARE NO PREMARKET APPROVAL APPLICATIONS FOR JANUARY 1995.
***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/S12 AVITENE MEDCHEM PRODUCTS, INC. MODIFIED
01/20/95 MICROFIBRILLAR
WOBURN, MA STERILIZATION
COLLAGEN HEMOSTAT 01801 CONDITIONS. TRADE
(MCH) NAME:SYRINGE AVITENE.
INDICATED FOR
SURGICAL PROCEDURES
AS AN ADJUNCT TO
HEMOSTASIS
P810055/S55 MODEL 820A PHARMACIA INC., APPROVAL FOR
01/27/95 POSTERIOR CHAMBER OPHTHALMICS MODEL 820A
INTRAOCULAR MONROVIA, CA POSTERIOR CHAMBER
LENSES (IOLS) 91017-7136 INTRAOCULAR LENSES
P810055/S56 ONE-PIECE PHARMACIA INC., APPROVAL TO
01/05/95 (NON-CM) OPHTHALMICS MANUFACTURE DEVICES
POSTERIOR CHAMBER MONROVIA, CA
APPROVED UNDER THIS
INTRAOCULAR 91017-7136 PMA AT AN ALTERNATE
LENSES (IOLS) MANUFACTURING SITE,
PHARMACIA PRODUCTION,
B.V., GRONINGEN, THE
NETHERLANDS.
P810055/S57 MODEL 727A PHARMACIA INC., ALTERNATE
01/05/95 POSTERIOR CHAMBER OPHTHALMICS MANUFACTURING SITE &
INTRAOCULAR MONROVIA, CA IMPLEMENT CEEON
LENSES (IOLS) 91017-7136 LABELING WITH CM
FEATURE MANUFACTURED
BY STRETCH OR
COMPRESSION-MOLDING
PROCESSES
P810055/S58 MODEL 734A
PHARMACIA INC., ALTERNATE
01/05/95 POSTERIOR CHAMBER OPHTHALMICS MANUFACTURING SITE &
INTRAOCULAR MONROVIA, CA IMPLEMENT CEEON
LENSES (IOLS) 91017-7136 LABELING WITH CM
FEATURE MANUFACTURED
BY STRETCH OR
COMPRESSION-MOLDING
PROCESSES
P810055/S59 ONE-PIECE CM PHARMACIA INC., ALTERNATE
01/05/95 POSTERIOR CHAMBER OPHTHALMICS MANUFACTURING SITE
INTRAOCULAR MONROVIA, CA LOCATED IN GRONINGEN,
LENSES (IOLS) 91017-7136 THE NETHERLANDS
P810055/S61 MODEL 809F PHARMACIA INC., APPROVAL FOR MODEL
01/27/95 ULTRAVIOLET- OPHTHALMICS 809F POSTERIOR
ABSORBING
MONROVIA, CA CHAMBER INTRAOCULAR
POSTERIOR CHAMBER 91017-7136 LENSES.
INTRAOCULAR
LENSES (IOLS)
P820003/S69 VERSATRAX MEDTRONIC, INC. MODIFICATIONS TO THE
01/23/95 PACING SYSTEM MINNEAPOLIS, MN MEMORY MODULE
55432-3576 (MEMMOD) MODELS 7455,
9725, 9737, 9742,
9743, 9746A, 9748,
9749, 9757, 9780,
9781, 9788, 9789, &
9791
P820083/S19 ULTEX EPTFE W.L. GORE & ASSOCIATES ADDITION OF U.S.P.
01/23/95 SUTURE FLAGSTAFF, AZ SIZES TO EXISTING
86003-2300 LINE OF GORE-TEX
EPTFE SUTURES. TRADE
NAME:ULTEX. INDICATED
FOR USE IN ALL TYPES
OF SOFT TISSUE
APPROXIMATIONS
P830026/S62 COSMOS II INTERMEDICS, INC. APPROVAL FOR PROGRAM
01/23/95 PACING SYSTEM ANGLETON, TX SOFTWARE MODULE AND
77515 LABELING CHANGES
P830026/S63 COSMOS FAMILY OF INTERMEDICS, INC. USE OF WILSON
01/23/95 PULSE GENERATORS ANGLETON, TX GREATBATCH BATTERIES
77515 WHICH HAVE UNDERGONE
A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P830045/S49 AFP CARDIAC PACESETTER, INC. USE OF WILSON
01/05/95 PACING SYSTEM SYLMAR, CA GREATBATCH BATTERIES
91392-9221 WHICH HAVE UNDERGONE
A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P830055/S35 NEW JERSEY LCS DEPUY, INC. ADDITION OF A ONE
01/18/95 TOTAL KNEE SYSTEM WARSAW, IN PIECE, POLYETHYLENE,
46581-0988 FIXED BEARING,
POSTERIOR CRUCIATE
SACRIFICING, TIBIAL
COMPONENT OPTION
P830061/S23 CAPSURE SP PACING MEDTRONIC, INC. MODIFICATIONS TO THE
01/31/95 LEAD MODELS 4023, MINNEAPOLIS, MN CAPSURE SP PACING
4024, & 4524 55432-3576 LEAD MODELS 4023, 4024,
AND 4524
P840001/S31 MEDTRONIC ITREAL MEDTRONIC NEUROLOGICAL USE OF PELLETHANE 75D
01/05/95 SPINAL CORD MINNEAPOLIS, MN AGED MORE THAN 2
STIMULATION SYSTEM 55440-9087 YEARS IN THE
CONNECTOR MODULES OF
ITREL I & II SPINAL
CORD STIMULATORS
P840001/S35 ITREL & ITREL MEDTRONIC, INC. MODIFICATIONS TO THE
01/23/95 SPINAL CORD
MINNEAPOLIS, MN MEMORY MODULE
STIMULATION SYSTEMS 55432-3576 (MEMMOD) MODELS 7455,
9725, 9737, 9742,
9743, 9746A, 9748,
9749, 9757, 9780,
9781, 9788, 9789, AND
9791
P840039/S45 MODEL P54OUV STORZ OPHTHALMICS, INC. APPROVAL FOR MODEL
01/10/95 ULTRAVIOLET- CLEARWATER, FL P54OUV
ABSORBING 34619 ULTRAVIOLET-ABSORBING
POSTERIOR CHAMBER POSTERIOR CHAMBER
INTRAOCULAR LENS LENS
(IOL)
P840040/S42 MEDITECH CORONARY BOSTON SCIENTIFIC ADDITION OF
01/23/95 BALLOON DILATION CORPORATION PROFESSIONAL CONTRACT
SYS
TEM NATICK, MA STERILIZATION AS A
01760-1537 CONTRACT STERILIZER
TO STERILIZE BSC PTCA
CATHETERS USING NEW
100% ETO
STERILIZATION CYCLE
P850051/S41 ACTIVITRAX MEDTRONIC, INC. CHANGE IN THE SHELF
01/31/95 PACING SYSTEM MINNEAPOLIS, MN LIFE FOR PELLETHANE
55432-3576 75D FROM THE CURRENTLY
SPECIFIED 2 TO 5 YEARS
P850051/S46 MEDTRONIC MEDTRONIC, INC. MARKET TWO MODELS OF
01/05/95 LEGEND II MINNEAPOLIS, MN PACEMAKERS UNDER AN
PULSE GENERATOR 55432-3576
ADDITIONAL BRAND NAME
MODELS 8424, AND MODEL NUMBERS
8426, & 8427
P850051/S48 MEDTRONIC SINGLE MEDTRONIC, INC. USE OF AN ALTERNATIVE
01/05/95 CHAMBER PACEMAKERS MINNEAPOLIS, MN SHIELD FINISH FOR THE
55432-3576 MINIX MODELS 8340,
8341, 8342, 8341M AND
MINIXST MODELS 8330,
8331, & 8331M
P850051/S49 MEDTRONIC SINGLE MEDTRONIC, INC. USE OF THE UNCOATED
01/05/95 CHAMBER PACEMAKERS MINNEAPOLIS, MN PETG PACKAGING
55432-3576 MATERIAL FOR THE
MINIX MODELS 8340,
8341, 8342, 8341M AND
MINIXST MODELS 8330,
8331, AND 8331M
P850089/S30 STERX TIP PACING MEDTRONIC, INC. ADDITION OF NEW STYLET
01/31/95 LEAD MODELS 5025 MINNEAPOLIS, MN TO STERILE PACKAGE OF
AND 5525 55432-3576 MDLS 5023M & 4162 LEADS
CAPSURE SP UPGRADE OF STAINLESS
MODEL 5023M & CPI STEEL COMPONENTS TIP
DEXATIP MODEL 316L VAR & DESIGN
4162 PACING LEADS CHANGES TO MDLS 5023M
& 4162 LEADS
P860003/S23 UVAR THERAKOS, INC. CHANGE IN LOCATION OF
01/26/95 PHOTOPHERESIS WEST CHESTER, PA MANUFACTURING
SYSTEM 19380 FACILITY FOR THE
CONTRACT
MANUFACTURER, LYDO
PRECISION PRODUCTS,
WHICH MANUFACTURERS
THE UVAR INSTRUMENT
P860007/S11 INTERTACH II INTERMEDICS, INC. APPROVAL FOR EXTERNAL
01/18/95 MODEL 262-16X ANGLETON, TX USE OF INTERTACH II
77515 MODEL 262-16X
P860019/S95 SCIMED PTCA SCIMED LIFE SYSTEMS APPROVAL FOR EXPRESS
01/23/95 CATHETERS SCIMED MAPLE GROVE, MN PLUS II PERCUTANEOUS
EXPRESS PLUS II 55311-1566 TRANSLUMINAL CORONARY
PTCA CATHETER ANGIOPLASTY CATHETER
P860019/S96 SCIMED PTCA SCIMED LIFE SYSTEMS, MODIFICATION TO THE
01/05/95 CATHETERS TRAPPER PLYMO
UTH, MN PACKAGING FOR TRAPPER
EXCHANGE DEVICE 55441-2644 EXCHANGE DEVICE
P870015/S19 MEDSTONE STS MEDSTONE NEW MANUFACTURING
01/06/95 EXTRACORPOREAL INTERNATIONAL, INC. FACILITY (MEDSTONE
SHOCK WAVE ALISO VIEJO, CA INTERNATIONAL, INC.,
LITHOTRIPTER 92656 ALISO VIEJO, CA.)
P870073/S12 THREE-PIECE STORZ OPHTHALMICS, INC. APPROVAL FOR MODELS
01/26/95 POSTERIOR CHAMBER CLEARWATER, FL P453UV & P454UV
INTRAOCULAR LENSES 34619 POSTERIOR CHAMBER
IOLS & THREE-PIECE
POSTERIOR CHAMBER IOLS
P880003/S34 OLYMPIX II CORDIS CORPORATION TRADE NAME CHANGE TO
01/05/95 PTCA DILATATION MIAMI, FL OLYMPIX II PTCA
CATHETER 33102-5700 DILATATION
CATHETER
P880006/S17 MULTILOG MODELS SIEMENS PACESETTER, APPROVAL FOR MULTILOG
01/12/95 2040T AND 2040K SYLMAR, CA MODELS 2040T AND
PULSE GENERATORS 91392-9221 2040K PULSE GENERATORS
P880070/S4 MODEL UV65 SERIES PHARMACIA INC., APPROVAL TO
01/23/95 ULTRAVIOLET- OPHTHALMICS MANUFACTURE ANTERIOR
ABSORBING MONROVIA, CA CHAMBER INTRAOCULAR
ANTERIOR CHAMBER 91017-7136 LENSES APPROVED UNDER
INTRAOCULAR LENSES THIS PMA AT AN
ALTERNATE
MANUFACTURING SITE
(GRONINGEN)
P880081/S17 MODEL SI-11NB ALLERGAN MEDICAL APPROVAL FOR MODEL
01/18/95 ULTRAVI
OLET- OPTICS, INC. SI-11NB
ABSORBING SILICONE IRVINE, CA ULTRAVIOLET-ABSORBING
POSTERIOR CHAMBER 92718 SILICONE POSTERIOR
INTRAOCULAR LENS CHAMBER INTRAOCULAR
(IOL) LENS
P880086/S26 SYNCHRONY CARDIAC PACESETTER, INC. FDA APOLOGIZES FOR
01/05/95 PACING SYSTEM SYLMAR, CA INCORRECTLY
PARAGON III 91392-9221 IDENTIFYING THE
MODELS 2314L, MODELS COVERED IN OUR
2314T, AND 2315M/S 10/31/94 APPROVAL
LETTER. THE CORRECT
MODEL NUMBER SHOULD
HAVE BEEN "2314T"
P880086/S30 SYNCHRONY CARDIAC PACESETTER, INC. USE OF WILSON
01/23/9
5 PACING SYSTEM SYLMAR, CA GREATBATCH BATTERIES
91392-9221 WHICH HAVE UNDERGONE
A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P890003/S25 SYNERGYST II MEDTRONIC, INC. CHANGE IN SHELF LIFE
01/31/95 PACING SYSTEM MINNEAPOLIS, MN FOR PELLETHANE 75D
55432-3576 FROM THE CURRENTLY
SPECIFIED 2 TO 5 YEARS
P890003/S28 MODEL 9870A MEDTRONIC, INC. APPROVAL FOR MODEL
01/11/95 SOFTWARE DISKETTES MINNEAPOLIS, MN 9870A SOFTWARE
55432-3576
DISKETTES
P890003/S31 THERA DR MODELS MEDTRONIC, INC. APPROVAL FOR THERA
01/10/95 ("SERIES 40"), MINNEAPOLIS, MN FAMILY OF
DR MODELS 55432-3576 PULSE GENERATORS
("SERIES 50"), ASSOCIATED PROGRAMMING
D MODELS, SOFTWARE MODELS
SR MODELS, S MODELS REFERENCED
PULSE GENERATORS,
MODEL 9875E/A
SOFTWARE,
MODEL 9757
MEMORYMOD
P890003/S33 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR
01/05/95 ELITE II MINNEAPOLIS, MN PERMISSION TO MARKET
PULSE GENERATOR 55432-3576 TWO MODELS OF
MODELS 7084, 7085, PACEMAKERS UNDER AN
AND 7086 ADDITIONAL BRAND NAME
AND MODEL NUMBERS
P890043/S26 SIMPSON CORONARY DEVICES VASCULAR APPROVAL FOR GRAFT &
01/31/95 ATHEROCATH INTERVENTION, INC. LARGE GRAFT SIZES OF
ATHEROCATH-GTO REDWOOD CITY, CA ATHEROCATH-GTO & FOR
7F G/LG 94063 NEW ADHESIVES ON THE
5, 6, AND 7 FRENCH
SIZES
P890070/S3 PURE-DENT B851 GRAIN PROCESSING NEW MANUFACTURING
01/27/95 CORPORATION SPECIFICATION FOR
MUSCATINE, IA PARTICLE SIZE
52761-0349 DISTRIBUTION THROUGH
US 400 MESH 80.1%
MINIMUM FOR
ABSORBABLE DUSTING POWDER PURE-DENT B851
P900023/S12 ABIOMED BVS 5000 ABIOMED, INC. ADDITIONAL SIZE
01/24/95 BI-VENTRICULAR DANVERS, MA ATRIAL CANNULA (I.E.,
SUPPORT SYSTEM 01923 46 FRENCH CANNULA
THAT TAPERS TO A 36
FRENCH DIAMETER) TO
BE USED WITH THE BVS
5000 BI-VENTRICULAR
SUPPORT SYSTEM
P900056/S4 ROTABLATOR HEART TECHNOLOGY, INC. APPROVAL FOR
01/24/95 ROTATIONAL REDMOND, WA ISOMEDIX, INC., EL
ANGIOPLASTY SYSTEM 98052-3376 PASO, TEXAS, AS AN
ADDITIONAL CONTRACT
STERILIZATION FACILITY
P910019/S1 IVT CORONARY INTERVENTIONAL APPROVAL FOR
01/05/95 ATHERECTOMY TECHNOLOGIES REPLACEMENT OF THE
SYSTEM (TEC) SAN DIEGO, CA CURRENT FILLET
92123 MATERIAL, FLEXAN,
WITH CONATHANE
POLYURETHANE
P910020/S4 RELAY/DASH INTERMEDICS, INC. COMMERCIAL
01/23/95 PACING SYSTEM ANGLETON, TX DISTRIBUTION OF
77515 UNITY C MODEL 292-06
PULSE GENERATOR;MODIFY
PROGRAM MODULE SOFTWARE
INCLUDING UNITY-C;
MODIFY LABELING
P91002
0/S6 RELAY/DASH INTERMEDICS, INC. ALTERNATIVE
01/18/95 PACING SYSTEM - ANGLETON, TX CONDUCTIVE (TYPE I,
RELAY (MODELS 77515-4000 GOLD-FILLED EPOXY)
294-03/293-03), AND NONCONDUCTIVE
DASH (MODELS (TYPE II EPOXY)
292/03/292-03R/ ADHESIVES ON THE
291-03), STRIDE HYBRID MODULE
(MODEL 294-05)
AND DART
(MODEL 292-05)
P910020/S7 RELAY/DASH INTERMEDICS, INC. NEW ADDITION TO RELAY
01/17/95 PACING SYSTEM - ANGLETON, TX FAMILY OF
RELAY 77515 PACERS:TRADE NAME:
(MODEL 294-03R) RATE RELAY (MODEL 294-03R)
RESPONSIVE, DUAL RATE RESPONSIVE, DUAL
CHAMBER IMPLANTABLE CHAMBER IMPLANTABLE
PULSE GENERATOR PULSE GENERATOR
P910023/S7 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR V-110
01/17/95 THERAPY SUNNYVALE, CA AND V-110B HEADER
DEFIBRILLATION 94086-6527 CONFIGURATIONS FOR
SYSTEM MODEL THE CADENCE V-110
V-110, V-110B SERIES
PULSE GENERATORS
P910023/S9 CADENCE TIERED VENTRITEX, INC. ADDING A SHIELD TO
01/23/95 THERAPY SUNNYVALE, CA THE MODEL AC-1000 AND
DEFIBRILLATION 94086-6527 AC-1501 PROGRAMMER
SYSTEM WANDS
P910073/S5 0070 ENDOTAK C LEADS CARDIAC PACEMAKERS, APPROVAL FOR
01/25/95 ST. PAUL, MN MANUFACTURER, DORADO
55112-5798
PUERTO RICO, TO
MANUFACTURE ENDOTAK
C LEAD MODELS 0070,
0072, AND 0074
***ORIGINAL VETERINARY NADAs***
141-035 PROGRAM DOGS CIBA AN HLTH LUFENURON
11-23-94 (TABLET) GREENSBORO, NC 45MG
27419 90MG
204.9MG
409.8MG
140-992 REVALOR-H HEIFERS ROUSSEL UCLAF ESTRADIOL
12-13-94 (EAR IMPLANT) DIV AGRO VETERINAIRE 2MG/PELLET
PARIS, FRANCE TRENBOLONE ACETATE
20MG/PELLET
***ORIGINAL ABBREVIATED VETERIN
ARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR JANUARY 1995.
***SUPPLEMENTAL VETERINARY NADAs***
200-008 OXY-TET 200/ CATTLE, BOEHRINGER INGELHEIM OXYTETRACYCLINE
11-16-94 BIO MYCIN 200 SWINE AN HLTH 200MG/ML
(INJECTABLE) ST JOSEPH, MO
64506
200-095 SACOX, CHICKENS HOECHST ROUSSEL CHLORTETRACYCLINE
11-25-94 AUREOMYCIN AGRI VET CALCIUM COMPLEX
(PREMIX) SOMERVILLE, NJ 500GM/TON
08876 SALINOMYCIN SODIUM
40-60GM/TON
200-096 SACOX, CHICKENS HOECHST ROUSSEL OXYTETRACYCLINE
11-25-94 TERRAMYCIN AGRI VET 500GM/TON
(PREMIX) SOMERVILLE, NJ SALINOMYCIN SODIUM
08876 40-60GM/TON
200-118 NEOMYCIN CATTLE, PHOENIX SCIENTIFIC NEOMYCIN SULFATE
11-29-94 (SOLUTION) GOATS, ST JOSEPH, MO 200MG/ML
SHEEP, 64506
SWINE
200-091 SACOX, 3-NITRO,CHICKENS HOECHST-ROUSSEL CHLORTETRACYCLINE
01-13-95 AUREOMYCIN AGRI VET CALCIUM COMPLEX
(PREMIX) SOMERVILLE, NJ 500GM/TON
08876 ROXARSONE
45.4GM/TON
SALINOMYCIN SODIUM
40-60GM/TON
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Date created: July 11, 1996; last updated: June 20, 2005 |
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