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FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 18 Number (5) May 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
19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM
02-MAY-95 (TABLET) PRINCETON, NJ 10MG
(SUPPL-009) 08543 20MG
40MG
(NEW INDICATION --
MANAGEMENT OF HEART
FAILURE
AS ADJUNCTIVE
THERAPY)
19-643 MEVACOR MERCK LOVASTATIN
03-MAY-95 (TABLET) WEST POINT, PA 10MG
(SUPPL-042) 19486 20MG
40MG
(NEW DOSAGE REGIMEN --
REVISED BASIS FOR
CALCULATING THE
RECOMMENDED STARTING
DOSE IN ACCORDANCE
WITH
THE 1993 NATIONAL
CHOLESTEROL
EDUCATION
PROGRAM GUIDELINES -
DOSING RANGE
EXPANDED
TO 10-80MG/DAY)
20-334 FLAGYL SEARLE METRONIDAZOLE
03-MAY-95 (CAPSULE) SKOKIE, IL 375MG
(5 S) 60077 (ANTIPROTOZOAL/
ANTIBACTERIAL)
50-722 CELLCEPT SYNTEX MYCOPHENOLATE MOFETIL
03-MAY-95 (CAPSULE) PALO ALTO, CA 250MG
(1 P) 94304 (IMMUNOSUPPRESSIVE)
[PROPHYLAXIS OF ORGAN
REJECTION IN PATIENTS
RECEIVING ALLOGENEIC
RENAL TRANSPLANTS]
19-721 NORDITROPIN NOVO NORDISK SOMATROPIN,
BIOSYNTHETIC
08-MAY-95 (INJECTABLE) PRINCETON, NJ 4MG/VIAL
(5 S) 08540 8MG/VIAL
(HUMAN GROWTH
HORMONE)
20-220 ULTRAVIST BERLEX IOPROMIDE
10-MAY-95 (INJECTABLE) WAYNE, NJ EQ 150MG IODINE/ML
(1 S) 07470 EQ 240MG IODINE/ML
EQ 300MG IODINE/ML
EQ 370MG IODINE/ML
(CONTRAST MEDIA)
20-406 PREVACID TAP HOLDINGS LANSOPRAZOLE
10-MAY-95 (CAPSULE, DEERFIELD, IL 15MG
(1 S) DELAYED RELEASE 60015 30MG
GRANULE) (GASTRIC ACID
SECRETION INHIBITOR)
18-735 ISOVUE-200 BRACCO DXS IOPAMIDOL
15-MAY-95 (INJECTABLE) PRINCETON, NJ 41%
(SUPPL-036) 08543 (ADDITIONAL DOSING
INFORMATION --
USE OF ISOVUE-370 IN
EXCRETORY UROGRAPHY
AT
EQUIVALENT GRAMS OF
IODINE
TO THE CURRENTLY
APPROVED
ISOVUE-250 AND
ISOVUE-300)
18-735 ISOVUE-250 BRACCO DXS IOPAMIDOL
15-MAY-95 (INJECTABLE) PRINCETON, NJ 51%
(SUPPL-036) 08543 (ADDITIONAL DOSING
INFORMATION --
USE OF ISOVUE-370 IN
EXCRETORY UROGRAPHY
AT
EQUIVALENT GRAMS OF
IODINE
TO THE CURRENTLY
APPROVED
ISOVUE-250 AND
ISOVUE-300)
18-735 ISOVUE-300 BRACCO DXS IOPAMIDOL
15-MAY-95 (INJECTABLE) PRINCETON, NJ 61%
(SUPPL-036) 08543 (ADDITIONAL DOSING
INFORMATION --
USE OF ISOVUE-370 IN
EXCRETORY UROGRAPHY
AT
EQUIVALENT GRAMS OF
IODINE
TO THE CURRENTLY
APPROVED
ISOVUE-250 AND
ISOVUE-300)
18-735 ISOVUE-370 BRACCO DXS IOPAMIDOL
15-MAY-95 (INJECTABLE) PRINCETON, NJ 76%
(SUPPL-036) 08543 (ADDITIONAL DOSING
INFORMATION --
USE OF ISOVUE-370 IN
EXCRETORY UROGRAPHY
AT
EQUIVALENT GRAMS OF
IODINE
TO THE CURRENTLY
APPROVED
ISOVUE-250 AND
ISOVUE-300)
50-664 CEFZIL BRISTOL MYERS SQUIBB CEFPROZIL
17-MAY-95 (TABLET) WALLINGFORD, CT 250MG
(SUPPL-004) 06492 500MG
(EXPANDED PATIENT
POPULATION --
TREATMENT OF
UNCOMPLICATED
SKIN AND SKIN
STRUCTURE
INFECTIONS IN
CHILDREN
2 YEARS TO 12 YEARS
OLD)
50-665 CEFZIL BRISTOL MYERS SQUIBB CEFPROZIL
17-MAY-95 (POWDER WALLINGFORD, CT 125MG/5ML
(SUPPL-004) FOR RECONSTITUTION) 06492 250MG/5ML
(EXPANDED PATIENT
POPULATION --
TREATMENT OF
UNCOMPLICATED
SKIN AND SKIN
STRUCTURE
INFECTIONS IN
CHILDREN
2 YEARS TO 12 YEARS
OLD)
20-059 ADENOSCAN MEDCO ADENOSINE
18-MAY-95 (INJECTABLE) RES TRIANGLE PK, NC 3MG/ML
(6 S) 27709 (NUCLEOSIDE)
[ADJUNCT TO THALLIUM-
201
MYOCARDIAL PERFUSION
SCINTIGRAPHY IN
PATIENTS
UNABLE TO EXERCISE
ADEQUATELY]
19-774 BIO-TROPIN BIO TECH GEN SOMATROPIN,
BIOSYNTHETIC
25-MAY-95 (INJECTABLE) ISELIN, NJ 4.8MG/VIAL
(5 S) 08830 (HUMAN GROWTH
HORMONE)
20-476 MOTRIN MCNEIL CONSUMER IBUPROFEN
25-MAY-95 (SUSPENSION/DROPS) FORT WASHINGTON, PA 40MG/ML
(3 S) 19034 (NONSTEROIDAL
ANTI-INFLAMMATORY)
20-212 ZINECARD PHARMACIA DEXRAZOXANE
26-MAY-95 (INJECTABLE) COLUMBUS, OH EQ 250MG BASE/VIAL
(1 P) 43216 EQ 500MG BASE/VIAL
(CARDIOPROTECTIVE)
[TO REDUCE THE
INCIDENCE
AND SEVERITY OF
CARDIOMYOPATHY
ASSOCIATED
WITH DOXORUBICIN
ADMINISTRATION IN
CERTAIN
BREAST CANCER
PATIENTS]
20-320 DEPAKOTE ABBOTT DIVALPROEX SODIUM
26-MAY-95 (TABLET, ABBOTT PARK, IL EQ 125MG VALPROIC
ACID
(6 S) DELAYED RELEASE) 60064 EQ 250MG VALPROIC
ACID
EQ 500MG VALPROIC
ACID
(ANTICONVULSANT/ANTIMANIC)
[TREATMENT OF MANIC
PHASE
OF BIPOLAR DISORDER]
***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.
20-147 TRAVASOL 2.75% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 2.75%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 5% 5GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 2.75% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 2.75%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 10% 10GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 2.75% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 2.75%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 15% 15GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 2.75% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 2.75%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 20% 20GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 2.75% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 2.75%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 25% 25GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
216MG/100ML
SODIUM CHLORIDE
112MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 4.25% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 4.25%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 5% 5GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 4.25% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 4.25%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 10% 10GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 4.25% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 4.25%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 15% 15GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 4.25% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 4.25%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 20% 20GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-147 TRAVASOL 4.25% - BAXTER AMINO ACIDS
09-MAY-95 SULFITE FREE - ROUND LAKE, IL 4.25%
W/ELECTROLYTES 60073 DEXTROSE
IN DEXTROSE 25% 25GM/100ML
IN PLASTIC CONTAINER MAGNESIUM CHLORIDE
(INJECTABLE) 51MG/100ML
POTASSIUM PHOSPHATE,
DIBASIC
261MG/100ML
SODIUM ACETATE
297MG/100ML
SODIUM CHLORIDE
77MG/100ML
(FLUID, NUTRIENT AND
ELECTROLYTE
REPLENISHER)
20-444 FLOLAN BURROUGHS WELLC EPOPROSTENOL SODIUM
09-MAY-95 (INJECTABLE) RES TRIANGLE PK, NC EQ 0.5MG BASE/VIAL
27709 EQ 1.5MG BASE/VIAL
(PROSTAGLANDIN)
[USE IN ADULTS FOR
THE
LONG-TERM INTRAVENOUS
TREATMENT OF PRIMARY
PULMONARY
HYPERTENSION IN
NYHA CLASS III AND
IV]
20-486 VANCERIL DS SCHERING BECLOMETHASONE
DIPROPIONATE
31-MAY-95 (AEROSOL, METERED) KENILWORTH, NJ 0.084MG/INH
07033 (CORTICOSTEROID)
***ORIGINAL ABBREVIATED NDAs***
74-393 ISOFLURANE MARSAM PHARMS ISOFLURANE
12-MAY-95 (LIQUID) CHERRY HILL, NJ 99.9%
08034 (GENERAL ANESTHETIC)
74-377* MEXILETINE HCL NOVOPHARM MEXILETINE
HYDROCHLORIDE
16-MAY-95 (CAPSULE) SCARBOROUGH, ONTARIO 150MG
CANADA 200MG
250MG
(ANTIARRHYTHMIC)
74-188 DIPIVEFRIN HCL BAUSCH AND LOMB DIPIVEFRIN
HYDROCHLORIDE
19-MAY-95 (SOLUTION/DROPS) TAMPA, FL 0.1%
33637 (ANTIGLAUCOMA)
40-056* LEUCOVORIN CALCIUM CETUS BEN VENUE LEUCOVORIN CALCIUM
23-MAY-95 (INJECTABLE) EMERYVILLE, CA EQ 200MG BASE/VIAL
94608 (FOLIC ACID
ANTAGONIST
ANTIDOTE)
73-541 CYCLOBENZAPRINE HCL BARR CYCLOBENZAPRINE
23-MAY-95 (TABLET) POMONA, NY HYDROCHLORIDE
10970 10MG
(SKELETAL MUSCLE
RELAXANT)
74-405 FLURBIPROFEN NOVOPHARM FLURBIPROFEN
24-MAY-95 (TABLET) SCARBOROUGH, ONTARIO 50MG
CANADA 100MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-401 CIMETIDINE ZENITH LABS CIMETIDINE
30-MAY-95 (TABLET) NORTHVALE, NJ 200MG
07647 300MG
400MG
(HISTAMINE H2-
RECEPTOR
ANTAGONIST)
* First Time Product Available Generically
74-402 CIMETIDINE ZENITH LABS CIMETIDINE
30-MAY-95 (TABLET) NORTHVALE, NJ 800MG
07647 (HISTAMINE H2-
RECEPTOR
ANTAGONIST)
74-185 DILTIAZEM HCL LEMMON DILTIAZEM
HYDROCHLORIDE
31-MAY-95 (TABLET) SELLERSVILLE, PA 30MG
18960 60MG
90MG
120MG
(CALCIUM ION
INFLUX INHIBITOR)
74-411 FLURBIPROFEN ZENITH LABS FLURBIPROFEN
31-MAY-95 (TABLET) NORTHVALE, NJ 50MG
07647 100MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-431 FLURBIPROFEN LEMMON FLURBIPROFEN
31-MAY-95 (TABLET) SELLERSVILLE, PA 100MG
18960 (NONSTEROIDAL
ANTI-INFLAMMATORY)
74-455 NAPROXEN SODIUM CHELSEA LABS NAPROXEN SODIUM
31-MAY-95 (TABLET) WEST HEMPSTEAD, NY EQ 250MG BASE
11552 EQ 500MG BASE
(NONSTEROIDAL
ANTI-INFLAMMATORY)
74-457 NAPROXEN CHELSEA LABS NAPROXEN
31-MAY-95 (TABLET) WEST HEMPSTEAD, NY 250MG
11552 375MG
500MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
***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.
THERE ARE NO ORIGINAL ABBREVIATED AND 505(B)(2) NDAs WITH TENTATIVE APPROVAL FOR
MAY 1995.
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
19-915 MONOPRIL BRISTOL MYERS SQUIBB FOSINOPRIL SODIUM
02-MAY-95 (TABLET) PRINCETON, NJ 10MG
08543 20MG
40MG
(LABELING REVISION --
CLINICAL
PHARMACOLOGY;
INDICATIONS AND
USAGE;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
18-206* LO/OVRAL-28 WYETH AYERST LABS ETHINYL ESTRADIOL
03-MAY-95 AND FERROUS FUMARATE PHILADELPHIA, PA 0.03MG
(TABLET) 19101 FERROUS FUMARATE
75MG
NORGESTREL
0.3MG
(LABELING REVISION --
PRECAUTIONS;
PATIENT PACKAGE
INSERT)
19-192 TRIPHASIL-21 WYETH AYERST ETHINYL ESTRADIOL
03-MAY-95 (TABLET) PHILADELPHIA, PA 0.03MG,0.04MG,0.03MG
19101 LEVONORGESTREL
0.05MG,0.075MG,0.125MG
(LABELING REVISION --
PATIENT PACKAGE
INSERT)
19-190 TRIPHASIL-28 WYETH AYERST ETHINYL ESTRADIOL
03-MAY-95 (TABLET) PHILADELPHIA, PA 0.03MG,0.04MG,0.03MG
19101 LEVONORGESTREL
0.05MG,0.075MG,0.125MG
(LABELING REVISION --
PATIENT PACKAGE
INSERT)
* - Not Marketed in the United States
19-643 MEVACOR MERCK LOVASTATIN
03-MAY-95 (TABLET) WEST POINT, PA 10MG
19486 20MG
40MG
LABELING REVISION --
CLINICAL
PHARMACOLOGY;
WARNINGS;
DOSAGE AND
ADMINISTRATION)
20-037 VOLTAREN CIBA VISION DICLOFENAC SODIUM
03-MAY-95 (SOLUTION/DROPS) DULUTH, GA 0.1%
30136 (LABELING REVISION --
WARNINGS)
20-261 LESCOL SANDOZ FLUVASTATIN SODIUM
03-MAY-95 (CAPSULE) EAST HANOVER, NJ EQ 20MG BASE
07936 EQ 40MG BASE
(LABELING REVISION --
CLINICAL
PHARMACOLOGY;
PRECAUTIONS;
OVERDOSAGE)
19-546 DYNACIRC SANDOZ ISRADIPINE
04-MAY-95 (CAPSULE) EAST HANOVER, NJ 2.5MG
07936 5MG
(LABELING REVISION --
PRECAUTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION)
17-395 INTROPIN FAULDING HOSP DOPAMINE
HYDROCHLORIDE
05-MAY-95 (INJECTABLE) ELIZABETH, NJ 40MG/ML
07207 80MG/ML
160MG/ML
(LABELING REVISION --
CONTRAINDICATIONS;
WARNINGS;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
19-851 LOTENSIN CIBA BENAZEPRIL
HYDROCHLORIDE
05-MAY-95 (TABLET) SUMMIT, NJ EQ 5MG BASE
07901 EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
(LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
20-033 LOTENSIN HCT CIBA BENAZEPRIL
HYDROCHLORIDE
05-MAY-95 (TABLET) SUMMIT, NJ 5MG
07901 HYDROCHLOROTHIAZIDE
6.25MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
20-033 LOTENSIN HCT CIBA BENAZEPRIL
HYDROCHLORIDE
05-MAY-95 (TABLET) SUMMIT, NJ 10MG
07901 HYDROCHLOROTHIAZIDE
12.5MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
20-033 LOTENSIN HCT CIBA BENAZEPRIL
HYDROCHLORIDE
05-MAY-95 (TABLET) SUMMIT, NJ 20MG
07901 HYDROCHLOROTHIAZIDE
12.5MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
20-033 LOTENSIN HCT CIBA BENAZEPRIL
HYDROCHLORIDE
05-MAY-95 (TABLET) SUMMIT, NJ 20MG
07901 HYDROCHLOROTHIAZIDE
25MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
20-131 PROHANCE BRACCO DXS GADOTERIDOL
08-MAY-95 (INJECTABLE) PRINCETON, NJ 279.3MG/ML
08543 (LABELING REVISION --
ADVERSE REACTIONS)
50-504 MANDOL ELI LILLY CEFAMANDOLE NAFATE
10-MAY-95 (INJECTABLE) INDIANAPOLIS, IN EQ 1GM BASE/VIAL
46285 EQ 2GM BASE/VIAL
EQ 10GM BASE/VIAL
(LABELING REVISION --
WARNINGS;
PRECAUTIONS;
STABILITY;
OVERDOSAGE)
09-321 CHOLOGRAFIN BRACCO DXS IODIPAMIDE MEGLUMINE
11-MAY-95 MEGLUMINE PRINCETON, NJ 10.3%
(INJECTABLE) 08543 52%
(LABELING REVISION --
BOXED WARNING)
12-157 NORFLEX 3M ORPHENADRINE CITRATE
11-MAY-95 (TABLET, ST PAUL, MN 100MG
EXTENDED RELEASE) 55144 (LABELING REVISION --
DESCRIPTION)
17-902 RENOVUE-65 BRACCO DXS IODAMIDE MEGLUMINE
11-MAY-95 (INJECTABLE) PRINCETON, NJ 65%
08543 (LABELING REVISION --
BOXED WARNING)
17-903 RENOVUE-DIP BRACCO DXS IODAMIDE MEGLUMINE
11-MAY-95 (INJECTABLE) PRINCETON, NJ 24%
08543 (LABELING REVISION --
BOXED WARNING)
18-076 CHOLOVUE BRACCO DXS IODOXAMATE MEGLUMINE
11-MAY-95 (INJECTABLE) PRINCETON, NJ 40.3%*
08543 (LABELING REVISION --
BOXED WARNING)
18-077 CHOLOVUE BRACCO DXS IODOXAMATE MEGLUMINE
11-MAY-95 (INJECTABLE) PRINCETON, NJ 9.9%*
08543 (LABELING REVISION --
BOXED WARNING)
19-048 DESOWEN GALDERMA LABS DESONIDE
11-MAY-95 (CREAM) FT WORTH, TX 0.05%
76163 (LABELING REVISION --
CLINICAL
PHARMACOLOGY;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
18-735 ISOVUE-200 BRACCO DXS IOPAMIDOL
15-MAY-95 (INJECTABLE) PRINCETON, NJ 41%
08543 (LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
18-735 ISOVUE-250 BRACCO DXS IOPAMIDOL
15-MAY-95 (INJECTABLE) PRINCETON, NJ 51%
08543 (LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
* - Product Not Marketed at This Time
18-735 ISOVUE-300 BRACCO DXS IOPAMIDOL
15-MAY-95 (INJECTABLE) PRINCETON, NJ 61%
08543 (LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
18-735 ISOVUE-370 BRACCO DXS IOPAMIDOL
15-MAY-95 (INJECTABLE) PRINCETON, NJ 76%
08543 (LABELING REVISION --
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION)
18-662 ACCUTANE ROCHE ISOTRETINOIN
17-MAY-95 (CAPSULE) NUTLEY, NJ 10MG
07110 20MG
40MG
(LABELING REVISION --
ADVERSE REACTIONS)
50-664 CEFZIL BRISTOL MYERS SQUIBB CEFPROZIL
17-MAY-95 (TABLET) WALLINGFORD, CT 250MG
06492 500MG
(LABELING REVISION --
DOSAGE AND
ADMINISTRATION)
50-665 CEFZIL BRISTOL MYERS SQUIBB CEFPROZIL
17-MAY-95 (POWDER WALLINGFORD, CT 125MG/5ML
FOR RECONSTITUTION) 06492 250MG/5ML
(LABELING REVISION --
DOSAGE AND
ADMINISTRATION)
20-330 TIMOPTIC-XE MERCK TIMOLOL MALEATE
18-MAY-95 (SOLUTION/DROPS) WEST POINT, PA EQ 0.025% BASE
19486 EQ 0.5% BASE
(LABELING REVISION --
DOSAGE AND
ADMINISTRATION;
INSTRUCTIONS FOR USE)
11-145 DIURIL MSD CHLOROTHIAZIDE
23-MAY-95 (INJECTABLE) WEST POINT, PA EQ 500MG BASE/VIAL
19486 (LABELING REVISION --
PRECAUTIONS)
11-145 DIURIL MSD CHLOROTHIAZIDE
23-MAY-95 (TABLET) WEST POINT, PA 250MG
19486 500MG
(LABELING REVISION --
PRECAUTIONS)
11-870 DIURIL MSD CHLOROTHIAZIDE
23-MAY-95 (SUSPENSION) WEST POINT, PA 250MG/5ML
19486 (LABELING REVISION --
PRECAUTIONS)
11-958 HYDROPRES 25 MSD HYDROCHLOROTHIAZIDE
23-MAY-95 (TABLET) WEST POINT, PA 25MG
19486 RESERPINE
0.125MG
(LABELING REVISION --
PRECAUTIONS)
11-958 HYDROPRES 50 MSD HYDROCHLOROTHIAZIDE
23-MAY-95 (TABLET) WEST POINT, PA 50MG
19486 RESERPINE
0.125MG
(LABELING REVISION --
PRECAUTIONS)
17-386 ZAROXOLYN FISONS METOLAZONE
23-MAY-95 (TABLET) ROCHESTER, NY 2.5MG
14623 5MG
10MG
(LABELING REVISION --
PRECAUTIONS;
WARNINGS)
19-532 MYKROX FISONS METOLAZONE
23-MAY-95 (TABLET) ROCHESTER, NY 0.5MG
14623 (LABELING REVISION --
PRECAUTIONS;
WARNINGS)
20-145 NITRO-DUR KEY PHARMS NITROGLYCERIN
23-MAY-95 (FILM, KENILWORTH, NJ 0.1MG/HR
EXTENDED RELEASE) 07033 0.2MG/HR
0.3MG/HR
0.4MG/HR
0.6MG/HR
0.8MG/HR
(LABELING REVISION --
ADVERSE REACTIONS)
17-060 NOR-QD SYNTEX NORETHINDRONE
26-MAY-95 (TABLET) PALO ALTO, CA 0.35MG
94303 (LABELING REVISION --
PRECAUTIONS;
STD STATEMENT)
16-191* SORBITRATE ZENECA ISOSORBIDE DINITRATE
30-MAY-95 (SUBLINGUAL, WILMINGTON, DE 2.5MG
TABLET) 19850 5MG
(LABELING REVISION --
CLINICAL
PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
* - Permitted
16-192* SORBITRATE ZENECA ISOSORBIDE DINITRATE
30-MAY-95 (TABLET) WILMINGTON, DE 5MG
19850 10MG
20MG
30MG
40MG
(LABELING REVISION --
CLINICAL
PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
16-776* SORBITRATE ZENECA ISOSORBIDE DINITRATE
30-MAY-95 (TABLET, WILMINGTON, DE 5MG
CHEWABLE) 19850 10MG
(LABELING REVISION --
CLINICAL
PHARMACOLOGY;
PRECAUTIONS;
DOSAGE AND
ADMINISTRATION)
19-778 PRINZIDE 10-12.5 MERCK HYDROCHLOROTHIAZIDE
30-MAY-95 (TABLET) WEST POINT, PA 12.5 MG
19486 LISINOPRIL
10MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
DOSAGE AND
ADMINISTRATION)
19-778 PRINZIDE 20-12.5 MERCK HYDROCHLOROTHIAZIDE
30-MAY-95 (TABLET) WEST POINT, PA 12.5MG
19486 LISINOPRIL
20MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
DOSAGE AND
ADMINISTRATION)
* - Permitted
19-778 PRINZIDE 20-25 MERCK HYDROCHLOROTHIAZIDE
30-MAY-95 (TABLET) WEST POINT, PA 25MG
19486 LISINOPRIL
20MG
(LABELING REVISION --
INDICATIONS AND
USAGE;
DOSAGE AND
ADMINISTRATION)
19-982 ZEBETA LEDERLE BISOPROLOL FUMARATE
30-MAY-95 (TABLET) PEARL RIVER, NY 5MG
10969 10MG
(LABELING REVISION --
ADVERSE REACTIONS)
20-186 ZIAC LEDERLE BISOPROLOL FUMARATE
30-MAY-95 (TABLET) PEARL RIVER, NY 2.5MG
10969 HYDROCHLOROTHIAZIDE
6.25MG
(LABELING REVISION --
ADVERSE REACTIONS)
20-186 ZIAC LEDERLE BISOPROLOL FUMARATE
30-MAY-95 (TABLET) PEARL RIVER, NY 5MG
10969 HYDROCHLOROTHIAZIDE
6.25MG
(LABELING REVISION --
ADVERSE REACTIONS)
20-186 ZIAC LEDERLE BISOPROLOL FUMARATE
30-MAY-95 (TABLET) PEARL RIVER, NY 10MG
10969 HYDROCHLOROTHIAZIDE
6.25MG
(LABELING REVISION --
ADVERSE REACTIONS)
20-220 ULTRAVIST BERLEX IOPROMIDE
30-MAY-95 (INJECTABLE) WAYNE, NJ EQ 150MG IODINE/ML
07470 EQ 240MG IODINE/ML
EQ 300MG IODINE/ML
EQ 370MG IODINE/ML
(LABELING REVISION --
CLINICAL TRIALS)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
0272 NONE MICHIGAN COMM BLOOD CTR CRYOPRECIPITATED AHF
01-MAY-95 (INJECTABLE) GRAND RAPIDS, MI (B)
49501
0274 NONE BERGEN COMM REG BLOOD CTR SOURCE LEUKOCYTES
01-MAY-95 (INJECTABLE) PARAMUS, NJ (B)
07652
1179 NONE SEIKAGAKU LIMULUS AMEBOCYTE
LYSATE
17-MAY-95 TOKYO, JAPAN (A,B)
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK950025 MTS INCUBATOR MICRO TYPING SYS INCUBATOR
08-MAY-95 POMPANO BEACH, FL (C)
33069
BK920034 ORTHO ORTHO DIAGN SYS BLOOD BANK CENTRIFUGE
FOR
09-MAY-95 BIOVUE SYSTEM RARITAN, NJ IN-VITRO DIAGNOSTIC
USE
08869 (C)
BK950009 CROSS-STAT ELISA SANGSTAT MED ELISA FOR DONOR
SPECIFIC
09-MAY-95 ANTI-HLA MENLO PK, CA ANTI-HLA CLASS I IgG
CLASS I IgG Ab 94025 (C)
BK920011 COBE SPECTRA COBE BCT AUTOMATED CELL
SEPARATOR
15-MAY-95 WITH PCM LAKEWOOD, CO (C)
80215
BK950002 CQUENTIAL DR DNA GEN TRAK LEUKOCYTE TYPING
TRAYS
15-MAY-95 TYPING KIT PLYMOUTH MEETING, PA (C)
19462
BK950004 GTI-PAK 2 GENETIC TESTING INST PLATELET ANTIBODY
15-MAY-95 PLATELET ANTIBODY BROOKFIELD, WI SCREENING KIT
SCREENING KIT 53045 (C)
BK950021 ALTON DEAN ALTON DEAN MED DRY HEAT BLOOD/
15-MAY-95 MODEL FW-437 WOODS CROSS, UT FLUID WARMER
84087 (C)
BK950026 MTS WORK TABLE MICRO TYPING SYS TEST TUBE RACK
15-MAY-95 POMPANO BEACH, FL (C)
33069
BK950005 GTI-HLA 1, GENETIC TESTING INST HLA SCREENING KIT
19-MAY-95 CLASS I BROOKFIELD, WI (C)
ANTIBODY 53045
SCREENING KIT
(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 THE MONTH OF MAY 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
N12159/S014 SURGICEL JOHNSON & JOHNSON DEVICE USED IN
05/12/95 ABSORBABLE MEDICAL, INC. ENDOSCOPIC PROCEDURES
HEMOSTAT AND ARLINGTON, TX
SURGICEL NU-KNIT 76004-3130
ABSORBABLE HEMOSTAT
N18286/S008 GELFOAM STERILE THE UPJOHN COMPANY REVISED CONTAINER
05/16/95 SPONGE PRODUCTS KALAMAZOO, MI LABELING
49001-0199
P800022/S046 ZYPLAST AND COLLAGEN CORPORATION MODIFICATIONS TO
05/24/95 ZYDERM COLLAGEN PALO ALTO, CA PRODUCT LABELING
IMPLANT 94303 RE:POLYMYOSITIS(PM)/
DERMATOMYOSITIS(DM)
P800024/S017 BAUSCH & LOMB BAUSCH & LOMB 2 FLUID OUNCE (60ML)
05/05/95 SENSITIVE EYES ROCHESTER, NY CONTAINER SIZE
PLUS SALINE 14692-0450
SOLUTION
P810031/S019 HEALON PHARMACIA, INC. OPHTHALMICS PROCEDURE THAT
05/03/95 MONROVIA, CA REVISES THE 100%
91017-7136 INSPECTION RELEASE
CRITERIA WHICH
CLASSIFIES THE
DEFECTS FOR THE
HEALON SODIUM
HYALURONATE PRODUCTS
P810032/S045 ULTRAVIOLET- ALCON LABORATORIES, INC. MODELS:CF50BA, CF57BA,
05/01/95 ABSORBING FORT WORTH, TX CF60B2, MC20BA,
MC20CM,
POSTERIOR CHAMBER 76134-2099 MC20C2, MC30BA,
MC30CM,
INTRAOCULAR LENSES MC50RM, MC60BM,
MC61BM,
MZ60BA, SK51RM,
SK60BM,
SK61BM
P850051/S050 LEGEND, LEGEND II, MEDTRONIC, INC. LABELING MODIFICATION
05/23/95 MICRO MINIX, MINNEAPOLIS, MN TO PROVIDE
CPI TRIUMPH VR, 55432-3576 USER/PHYSICIAN W/INFO
AND VITATRON RE:PATIENTS' USE OF
LEGACY SR CELLULAR PHONES IN
PACING SYSTEMS PROXIMITY TO THEIR
IMPLANTED
PULSE GENERATOR
P850077/S018 REVOLUTION SUNSOFT CORPORATION ALTERNATE
05/05/95 ASPHERIC MULTIFOCAL ALBUQUERQUE, NM MANUFACTURING SITE
(METHAFILCON A) 87109 FOR PRODUCTION OF THE
SOFT (HYDROPHILIC) DEVICE:SUNSOFT, CORP.
CONTACT LENS 6815 ACADEMY PARKWAY
WEST ALBUQUERQUE, NM
87109
P850077/S020 SUNSOFT SUNSOFT CORPORATION REVISED PROFESSIONAL
05/05/95 (METHAFILCON A) ALBUQUERQUE, NM FITTING GUIDE
SOFT (HYDROPHILIC) 87109
CONTACT LENS
P850077/S021 PROFILS ASPHERIC SUNSOFT CORPORATION ALTERNATE
05/25/95 MULTIFOCAL AND ALBUQUERQUE, NM MANUFACTURING PROCESS
MULTIPLES TORIC 87109 COMBINING THE
(METHAFILCON A) MOLDING/LATHING
SOFT (HYDROPHILIC) PROCESSES
CONTACT LENSES
P850079/S026 HYDRASOFT, COOPERVISION, INC. ADD THE MONOVISION
05/15/95 HYDRASOFT XW, IRVINE, CA FITTING TECHNIQUE TO
HYDRASOFT TORIC, 92718 THE LABELING OF A
HYDRASOFT TORIC XW, SINGLE VISION
HYDROPHILIC CONTACT LENS TO MANAGE
CONTACT LENSES PRESBYOPIA
P850088/S032 ULTRACARE ALLERGAN CHANGE IN PH AND
05/15/95 NEUTRALIZING TABLETS, IRVINE, CA OSMOLALITY TEST
METHODS
ULTRACARE 92713
NEUTRALIZING
TABLETS WITH
COLOR INDICATOR
P860003/S024 THERAKOS UVAR THERAKOS, INC. CHANGE IN LABELING
05/18/95 PHOTOPHERESIS SYSTEM WEST CHESTER, PA FOR THE TK001
19380 PHOTOPHERESIS KIT AND
THE UVAR INSTRUMENT
DATA PLATE LABEL
P860004/S034 MEDTRONIC MEDTRONIC NEUROLOGICAL ADDITIONAL GRAPH TO
05/22/95 SYNCHROMED MINNEAPOLIS, MN BE ADDED TO THE
INFUSION SYSTEM 55440-9087 SYNCHROMED INFUSION
SYSTEM TECHNICAL
MANUALS
P860019/S097 SCIMED PTCA SCIMED LIFE SYSTEMS, INC. NEW LINE OF OVER-THE
05/16/95 CATHETERS BANDIT, MAPLE GROVE, MN WIRE PTCA CATHETERS &
LONG BANDIT 30, 55311-1566 MODIFICATIONS TO LEAP
AND LONG BANDIT TRIO 14 PTCA CATHETER
40 PTCA CATHETERS
P860019/S098 SCIMED PTCA SCIMED LIFE SYSTEMS, INC. MODIFICATIONS TO THE
05/16/95 CATHETERS MAPLE GROVE, MN TRIO 14 PTCA CATHETER
55311-1566 MODIFIED DEVICE WILL
BE MARKETED UNDER THE
TRADE NAME:POC BANDIT
P860019/S099 SCIMED PTCA SCIMED LIFE SYSTEMS, INC. REVISED LABELING
05/16/95 CATHETERS MAPLE GROVE, MN
55311-1566
P860061/S009 COMPLETE BRAND ALLERGAN OPTICAL ADDITIONAL ENZYME
05/25/95 WEEKLY ENZYMATIC IRVINE, CA TABLET FORMULATION
CLEANER 92713-9534 FOR THE ULTRAZYME
ENZYMATIC CLEANER
P870036/S034 MEDTRONIC MEDTRONIC NON-PIGMENTED INNER
05/16/95 PANTHER, PANTHER 30, INTERVENTIONAL VASC LUMEN VERSION OF
& PANTHER 40 SAN DIEGO, CA PANTHER PTCA
CORONARY BALLOON 92121-2256 CATHETERS
DILATATION CATHETERS
P870048/S006 MICROTRAK II SYVA COMPANY ADDITION OF AN
05/10/95 HBEAG EIA SAN JOSE, CA AUTOMATED INSTRUMENT
95161-9013 SYSTEM, THE MICRO
TRAK XL, FOR THE
PERFORMANCE OF THE
MICRO TRAK II HBEAG
EIA
P870048/S007 MICROTRAK II SYVA COMPANY MICROTRAK II ANTI-HBE
05/10/95 ANTI-HBE EIA FOR SAN JOSE, CA EIA FOR USE ON THE
USE ON THE 95161-9013 MICROTRAK XL
MICROTRAK XL INSTRUMENT
INSTRUMENT
P870049/S023 MICROSCAN RAPID BAXTER DIAGNOSTICS, LIMITATION STATEMENT
05/05/95 FLUORGENIC GRAM INC. - MICROSCAN CONTRAINDICATING THE
POSITIVE PANELS WEST SACRAMENTO, CA TESTING OF
95691 PNEUMOCOCCAL ISOLATES
WITH MICROSCAN RAPID
PANELS
P880003/S041 WORLDPASS PTCA CORDIS CORPORATION REVISED LABELING
05/17/95 DILATATION CATHETER MIAMI, FL
33102-5700
P880003/S046 SLEEK PTCA CORDIS CORPORATION REVISED LABELING
05/22/95 DILATATION CATHETER MIAMI, FL
33102-5700
P880003/S047 OLYMPIX & CORDIS CORPORATION REVISED LABELING
05/22/95 SLEUTH XT PTCA MIAMI, FL
DILATATION CATHETERS 33102-5700
P80027/S035 SCHNEIDER SCHNEIDER (USA), INC. REVISED LABELING
05/16/95 MC RAIL 20/30/40, PFIZER HOSPITAL PROD
MYSTIC MC 20/30/40, MINNEAPOLIS, MN
FORTE18, FORTE30, 55442
MAGNARAIL FREEHAND,
MYSTIC MONGOOSE, &
MAGNUM-MEIER PTCA
CATHETERS
P880090/S010 STORZ MODEL 121UV STORZ OPHTHALMICS, INC. LABELING CHANGES
05/22/95 & S121UV CLEARWATER, FL
UV-ABSORBING 34619
ANTERIOR CHAMBER
INTRAOCULAR LENS
P890003/S038 ELITE, ELITE II, MEDTRONIC, INC. LABELING MODIFICATION
05/23/95 MINUET, MINNEAPOLIS, MN TO PROVIDE
CPI PRELUDE DR, 55432-3576 USER/PHYSICIAN INFO
CPI TRIUMPH DR, RE:PATIENTS USE OF
VITATRON CELLULAR PHONES IN
LEGACY DR, VITATRON PROXIMITY TO THE
LEGACY D, IMPLANTED PULSE
THERA DR, THERA D, GENERATOR
THERA SR, & THERA S
P890019/S004 MICROTRAK II SYVA COMPANY MICROTRACK II
05/10/95 TOTAL ANTI-HAV SAN JOSE, CA ANTI-HAV EIA FOR USE
EIA FOR USE ON 95161 ON THE MICROTRAK XL
THE MICROTRAK XL INSTRUMENT
INSTRUMENT
P890027/S023 NUCLEUS 22 COCHLEAR CORPORATION USE OF ALTERNATE
05/15/95 CHANNEL COCHLEAR ENGLEWOOD, CO HEADSET CABLES
IMPLANT FOR USE WITH 80112
POSTLINGUISTICALLY
PROFOUNDLY DEAFENED
CHILDREN AGES 2-18
P890032/S021 CORDIS ORION CORDIS CORPORATION REVISED LABELING
05/17/95 STEERABLE PTCA MIAMI, FL
BALLOON 33102-5700
CATHETER-CORDIS
LIGHTNING
STEERABLE PTCA
BALLOON CATHETERS
P890039/S014 MAESTRO II SAVVI CARDIAC CONTROL SYSTEMS, INC. VENDOR SUPPLIED
05/16/95 PACING SYSTEM PALM COAST, FL BATTERIES
MODELS 325 & 333 32164 MANUFACTURED BY
ACCELERATED BURN-IN
PROCESS
P890048/003 USCI PROBE III C.R. BARD, INC. PLANNED MOVE OF
05/17/95 BALLOON-ON-A-WIRE BILLERICA, MA PACKAGING EQUIPMENT
DILATATION SYSTEM 01821 AND OPERATIONS FROM
THE HAVERHILL
FACILITY TO THE
BILLERICA FACILITY
P900022/S004 CHORUS II DDD ELA MEDICAL, INC. VENDOR SUPPLIED
05/16/95 PACING SYSTEM MINNETONKA, MN BATTERIES
MODELS 6001, 6003, 55345 MANUFACTURED BY
6004, 6033, AND 6034 ACCELERATED BURN-IN
PROCESS
P900056/S008 ROTABLATOR HEART TECHNOLOGY, INC. ADDITION OF A 2.38MM
05/22/95 ROTATIONAL REDMOND, WA BURR TO THE
ANGIOPLASTY SYSTEM 98052-3376 ROTABLATOR
ADVANCER/CATHETER
BURR SIZES
P910001/S010 EXTREME CATHETERS SPECTRANETICS MODIFICATION TO THE
05/16/95 (MDLS 114-006, CORPORATION OPTICAL COUPLER OF
117-009, 120-006), COLORADO SPRINGS, CO THE EXTREME CATHETERS
VITESSE-C II 80907 AND VITESSE-C II
CATHETERS CATHETERS
(MDLS 114-007,
117-010, 120-007)
P910030/S003 GIANTURCO-ROUBIN MED INSTITUTE, INC. A 12MM VERSION OF
05/17/95 FLEX-STENT WEST LAFAYETTE, IN THE STENT AND REVISION
CORONARY STENT 47906 OF INSTRUCTIONS FOR
USE
(12MM LENGTH) FOR THE 20MM VERSION
P910073/S013 ENDOTAK C LEAD CARDIAC PACEMAKERS, INC. NEW MODELS
05/16/95 MODELS 0113 & 0115 ST PAUL, MN ENDOTAK C LEAD
55112-5798 MODELS 0113 AND 0115
P910075/S003 COMPLETE BRAND ALLERGAN OPTICAL APPROVAL FOR A 16FL OZ
05/15/95 MULTI-PURPOSE IRVINE, CA SIZE OF COMPLETE
SOLUTION 92713-9534 BRAND MULTI-PURPOSE
SOLUTION
P910077/S002 VENTAK PRX III CARDIAC PACEMAKERS, INC. NEW MODELS FOR THE
05/02/95 AICD SYSTEM ST PAUL, MN PULSE GENERATOR
55112-5798 PROGRAMMED RECORDER
SOFTWARE, LEADS,
PATCHES, CONNECTORS,
ETC.
P920047/S005 STEEROCATH EP TECHNOLOGIES, INC. ADDITION OF WARNING
05/16/95 STEERABLE SUNNYVALE, CA TO THE LABELING OF
ABLATION CATHETER 94086 THE STEEROCATH
AND EPT-1000 STEERABLE ABLATION
CATHETER AND THE
EPT-1000 CARDIAC
ABLATION CONTROLLER,
INSTRUCTIONS FOR USE
P930029/S001 ATAKR RADIO MEDTRONIC CARDIORHYTHM LABELING CHANGES
05/17/95 FREQUENCY SAN JOSE, CA
CATHETER ABLATION 95134-1806
(RFCA) SYSTEM
P930029/S003 ATAKR RFCA SYSTEM MEDTRONIC CARDIORHYTHM ADDITION OF TRACKING
05/25/95 SAN JOSE, CA NUMBERS TO THE
95134-1806 PROXIMAL SHAFT OF ALL
ABLATR AND MARINR
CATHETERS
P930035/S002 VENTAK P2 CARDIAC PACEMAKERS, INC. ALTERNATE
05/25/95 AICD SYSTEM ST PAUL, MN STERILIZATION PROCESS
55112 USING OXYFUME 2000
***ORIGINAL VETERINARY NADAs***
THERE ARE NO ORIGINAL VETERINARY NADAs FOR MAY 1995.
***ORIGINAL ABBREVIATED VETERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR MAY 1995.
***SUPPLEMENTAL VETERINARY NADAs***
055-020 AUREOMYCIN CATTLE AM CYANAMID CHLORTETRACYCLINE
04-06-95 (POWDER) WAYNE, NJ BISULFATE
07470 (102.4GM
CHLORTETRACYCLINE
HYDROCHLORIDE
ACTIVITY/LB OF
CHLORTETRACYCLINE
BISULFATE)
Date created: October 25, 1996; last updated: June 20, 2005 |
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