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FDA DRUG AND DEVICE PRODUCT APPROVALSVolume 18 Number (7) July 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
20-379 CAVERJECT UPJOHN ALPROSTADIL
06-JUL-95 (INJECTABLE) KALAMAZOO, MI 0.01MG/VIAL
(3 P) 49001 0.02MG/VIAL
(PROSTAGLANDIN)
[TREATMENT OF ERECTILE
DYSFUNCTION DUE TO
NEUROGENIC, VASCULOGENIC,
PSYCHOGENIC, OR MIXED
ETIOLOGY]
20-488 MAGNESIUM SULFATE ABBOTT MAGNESIUM SULFATE
11-JUL-95 IN DEXTROSE 5% ABBOTT PARK, IL 1GM/100ML
(3 S) IN PLASTIC CONTAINER 60064 2GM/100ML
(INJECTABLE) (ANTICONVULSANT)
[PREVENTION AND CONTROL OF
SEIZURES (CONVULSIONS) IN
SEVERE TOXEMIA OF PREGNANCY]
19-221 VASERETIC MERCK ENALAPRIL MALEATE
12-JUL-95 (TABLET) WEST POINT, PA 5MG
(SUPPL-015) 19486 HYDROCHLOROTHIAZIDE
12.5MG
(NEW STRENGTH)
[NEW DOSING REGIMEN --
5MG ENALAPRIL MALEATE AND
12.5MG HYDROCHLOROTHIAZIDE]
19-221 VASERETIC MERCK ENALAPRIL MALEATE
12-JUL-95 (TABLET) WEST POINT, PA 10MG
(SUPPL-015) 19486 HYDROCHLOROTHIAZIDE
25MG
(NEW DOSING REGIMEN --
5MG ENALAPRIL MALEATE AND
12.5MG HYDROCHLOROTHIAZIDE)
50-715 NEORAL SANDOZ CYCLOSPORINE
14-JUL-95 (CAPSULE) EAST HANOVER, NJ 25MG
(3 S) 07936 50MG
100MG
(IMMUNOSUPPRESSANT)
[PROPHYLAXIS OF ORGAN
REJECTION IN KIDNEY,
LIVER, AND HEART
ALLOGENEIC TRANSPLANTS]
50-716 NEORAL SANDOZ CYCLOSPORINE
14-JUL-95 (SOLUTION) EAST HANOVER, NJ 100MG/ML
(3 S) 07936 (IMMUNOSUPPRESSANT)
[PROPHYLAXIS OF ORGAN
REJECTION IN KIDNEY,
LIVER, AND HEART
ALLOGENEIC TRANSPLANTS]
***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.
19-971 DEXTROSE 5% DHL DEXTROSE
06-JUL-95 IN PLASTIC CONTAINER UNION, SC 5GM/100ML
(INJECTABLE) 29379 (FLUID AND NUTRIENT
REPLENISHER)
50-704 DAUNOXOME VESTAR LIPOSOMAL DAUNORUBICIN
10-JUL-95 (INJECTABLE) SAN DIMAS, CA CITRATE
91773 EQ 2MG BASE/ML
(ANTINEOPLASTIC)
[PRIMARY THERAPY FOR THE
PALLIATIVE MANAGEMENT OF
ADVANCED, HIV-ASSOCIATED
KAPOSI'S SARCOMA]
20-372 MYOVIEW MEDI PHYSICS TECHNETIUM TC-99M
13-JUL-95 (INJECTABLE) ARLINGTON HEIGHTS, IL TETROFOSMIN KIT
60005 N/A
(RADIOACTIVE DIAGNOSTIC)
[DELINEATION OF REGIONS
OF REVERSIBLE MYOCARDIAL
ISCHEMIA]
20-451 PHOTOFIN QLT PORFIMER SODIUM
13-JUL-95 (INJECTABLE) SEATTLE, WA 75MG/VIAL
98101 (PHOTOSENSITIZER)
[USE IN PHOTODYNAMIC
THERAPY FOR REDUCTION OF
OBSTRUCTION AND PALLIATION
OF DYSPHAGIA IN PATIENTS
WITH COMPLETELY OR PARTIALLY
OBSTRUCTING ESOPHAGEAL
CANCER]
20-429 KETOPROFEN WHITEHALL ROBINS KETOPROFEN
19-JUL-95 (TABLET) MADISON, NJ 12.5MG
07940 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
20-499 ACTRON BAYER KETOPROFEN
19-JUL-95 (TABLET) WEST HAVEN, CT 12.5MG
06516 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
20-510 SPORANOX JANSSEN ITRACONAZOLE
25-JUL-95 (CAPSULE) TITUSVILLE, NJ 100MG
08560 (ANTIFUNGAL)
[ONCHOMYCOSIS OF THE
TOENAIL WITH OR WITHOUT
FINGERNAIL INVOLVEMENT]
20-439 VESANOID ROCHE TRETINOIN
27-JUL-95 (CAPSULE) NUTLEY, NJ 10MG
07110 (RETINOID)
[INDUCTION OF REMISSION IN
PATIENTS WITH ACUTE
PROMYELOCYTIC LEUKEMIA (APL)
WHO ARE REFRACTORY TO,
OR WHO HAVE RELAPSED FROM,
ANTHRACYCLINE CHEMOTHERAPY]
***ORIGINAL ABBREVIATED NDAs***
40-061 ROXILOX ROXANE ACETAMINOPHEN
03-JUL-95 (CAPSULE) COLUMBUS, OH 500MG
43216 OXYCODONE HYDROCHLORIDE
5MG
(ANALGESIC)
74-076 LACTULOSE HI TECH PHARMA LACTULOSE
03-JUL-95 (SOLUTION) AMITYVILLE, NY 10GM/15ML
[DYE FREE] 11701 (LAXATIVE)
74-077 LACTULOSE HI TECH PHARMA LACTULOSE
03-JUL-95 (SOLUTION) AMITYVILLE, NY 10GM/15ML
11701 (AMMONIA DETOXICANT)
40-014 LIDOCAINE HCL HI TECH PHARMA LIDOCAINE HYDROCHLORIDE
10-JUL-95 (SOLUTION) AMITYVILLE, NY 2%
11701 (TOPICAL ANESTHETIC)
74-290 ETOPOSIDE BEN VENUE ETOPOSIDE
17-JUL-95 (INJECTABLE) BEDFORD, OH 20MG/ML
44146 (ANTINEOPLASTIC)
74-509 AMANTADINE HCL PHARM ASSOC AMANTADINE HYDROCHLORIDE
17-JUL-95 (SYRUP) CONESTEE, SC 50MG/5ML
29636 (ANTIVIRAL)
74-299* INDAPAMIDE ZENITH LABS INDAPAMIDE
27-JUL-95 (TABLET) NORTHVALE, NJ 2.5MG
07647 (DIURETIC)
64-140 DOXORUBICIN HCL GENSIA DOXORUBICIN HYDROCHLORIDE
28-JUL-95 (INJECTABLE) IRVINE, CA 2MG/ML
92718 200MG/100ML
(ANTINEOPLASTIC)
72-489 ACETYLCYSTEINE LUITPOLD ACETYLCYSTEINE
28-JUL-95 (SOLUTION) SHIRLEY, NY 10%
11967 (MUCOLYTIC)
* - First Time Product Available Generically
72-547 ACETYLCYSTEINE LUITPOLD ACETYLCYSTEINE
28-JUL-95 (SOLUTION) SHIRLEY, NY 20%
11967 (MUCOLYTIC)
72-888 VERAPAMIL HCL BEDFORD VERAPAMIL HYDROCHLORIDE
28-JUL-95 (INJECTABLE) BEDFORD, OH 2.5MG/ML
44146 (CALCIUM ION FLUX INHIBITOR)
74-424 CIMETIDINE BAKER NORTON CIMETIDINE
28-JUL-95 (TABLET) MIAMI, FL 200MG
33178 300MG
400MG
800MG
(HISTAMINE H2-RECEPTOR
ANTAGONIST)
74-448 FLURBIPROFEN GENEVA PHARMS FLURBIPROFEN
28-JUL-95 (TABLET) BROOMFIELD, CO 50MG
80020 100MG
(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.
74-477 CAPTOPRIL HALLMARK PHARMA CAPTOPRIL
31-JUL-95 (TABLET) SOMERSET, NJ 12.5MG
08873 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
17-087 ETHRANE OHMEDA ENFLURANE
05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9%
07938 (LABELING REVISION --
PRECAUTIONS)
17-624 FORANE OHMEDA ISOFLURANE
05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9%
07938 (LABELING REVISION --
PRECAUTIONS)
20-118 SUPRANE OHMEDA DESFLURANE
05-JUL-95 (LIQUID) LIBERTY CORNER, NJ 99.9%
07938 (LABELING REVISION --
PRECAUTIONS)
20-088 NORPLANT SYSTEM WYETH AYERST LEVONORGESTREL
07-JUL-95 (IMPLANT) PHILADELPHIA, PA 36MG/IMPLANT
19101 (LABELING REVISION --
PATIENT PACKAGE INSERT)
17-911 CLINORIL MERCK SULINDAC
10-JUL-95 (TABLET) WEST POINT, PA 150MG
19486 200MG
(LABELING REVISION --
GENERIC LABELING)
20-216 PREMARIN AYERST ESTROGENS, CONJUGATED
11-JUL-95 (CREAM) PHILADELPHIA, PA 0.625MG/GM
19101 (LABELING REVISION --
DOSAGE AND ADMINISTRATION)
20-216 PREMARIN AYERST ESTROGENS, CONJUGATED
11-JUL-95 (CREAM) PHILADELPHIA, PA 0.625MG/GM
19101 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
19-221 VASERETIC MERCK ENALAPRIL MALEATE
12-JUL-95 (TABLET) WEST POINT, PA 5MG
19486 HYDROCHLOROTHIAZIDE
12.5MG
(LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-221 VASERETIC MERCK ENALAPRIL MALEATE
12-JUL-95 (TABLET) WEST POINT, PA 10MG
19486 HYDROCHLOROTHIAZIDE
25MG
(LABELING REVISION --
DESCRIPTION;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-415 METRODIN SERONO UROFOLLITROPIN
12-JUL-95 (INJECTABLE) NORWELL, MA 75IU/AMP
02061 (LABELING REVISION --
ADVERSE REACTIONS)
19-901 ALTACE HOECHST ROUSSEL RAMIPRIL
13-JUL-95 (CAPSULE) SOMERVILLE, NJ 1.25MG
08876 2.5MG
5MG
10MG
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS;
ADVERSE REACTIONS;
OVERDOSAGE)
11-642* CARDIOQUIN PURDUE FREDERICK QUINIDINE
14-JUL-95 (TABLET) NORWALK, CT POLYGALACTURONATE
06850 275MG
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND ADMINISTRATION;
HOW SUPPLIED)
19-834 PLENDIL ASTRA MERCK FELODIPINE
14-JUL-95 (TABLET, WAYNE, PA 2.5MG
EXTENDED RELEASE) 19087 5MG
10MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
19-908 AMBIEN LOREX ZOLPIDEM TARTRATE
14-JUL-95 (TABLET) SKOKIE, IL 5MG
60077 10MG
(LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
PRECAUTIONS;
ADVERSE REACTIONS;
DRUG ABUSE AND DEPENDENCE;
HOW SUPPLIED)
* - Permitted
07-529 QUINIDINE GLUCONATE LILLY QUINIDINE GLUCONATE
20-JUL-95 (INJECTABLE) INDIANAPOLIS, IN 80MG/ML
46285 (LABELING REVISION --
DESCRIPTION;
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE)
18-830 TAMBOCOR 3M FLECAINIDE ACETATE
20-JUL-95 (TABLET) ST PAUL, MN 50MG
55144 100MG
150MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
19-655 RETROVIR BURROUGHS WELLC ZIDOVUDINE
20-JUL-95 (CAPSULE) RES TRIANGLE PK, NC 100MG
27709 (LABELING REVISION --
PRECAUTIONS)
19-910 RETROVIR BURROUGHS WELLC ZIDOVUDINE
20-JUL-95 (SYRUP) RES TRIANGLE PK, NC 50MG/5ML
27709 (LABELING REVISION --
PRECAUTIONS)
19-951 RETROVIR BURROUGHS WELLC ZIDOVUDINE
20-JUL-95 (INJECTABLE) RES TRIANGLE PK, NC 10MG/ML
27709 (LABELING REVISION --
PRECAUTIONS)
18-680 COPPER T POPULATION COUNCIL COPPER
24-JUL-95 MODEL TCU 380A NEW YORK, NY APPROX 309MG COPPER
(INTRAUTERINE DEVICE) 10021 (LABELING REVISION --
DESCRIPTION)
20-340 TEMOVATE E GLAXO CLOBETASOL PROPIONATE
24-JUL-95 (CREAM) RES TRIANGLE PK, NC 0.05%
13438 (LABELING REVISION --
NEW TRADE NAME)
19-865 BETAPACE BERLEX SOTALOL HYDROCHLORIDE
26-JUL-95 (TABLET) WAYNE, NJ 80MG
07470 160MG
240MG
(LABELING REVISION --
WARNINGS; PRECAUTIONS;
DOSAGE AND ADMINISTRATION)
18-631 TRENTAL HOECHST ROUSSEL PENTOXIFYLLINE
28-JUL-95 (TABLET, SOMERVILLE, NJ 400MG
EXTENDED RELEASE) 08876 (LABELING REVISION --
PRECAUTIONS;
HOW SUPPLIED)
19-201 VOLTAREN GEIGY DICLOFENAC SODIUM
28-JUL-95 (TABLET, SUMMIT, NJ 25MG
DELAYED RELEASE) 07901 50MG
75MG
(LABELING REVISION --
PRECAUTIONS)
20-142 CATAFLAM GEIGY DICLOFENAC POTASSIUM
28-JUL-95 (TABLET) SUMMIT, NJ 50MG
07901 (LABELING REVISION --
PRECAUTIONS)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
1186 T R U E TEST PHARMACIA RES CTR ALLERGEN PATCH TEST
19-JUL-95 (PATCH) A/S, DK-3400 (TOPICAL)
HILLEROD (A,B)
DENMARK
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
THERE ARE NO BIOLOGICAL PRODUCT DEVICE APPROVALS FOR JULY 1995.
***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
P910003 WESLEY-JESSEN WESLEY-JESSEN INDICATED FOR USE
07/07/95 COE-405 DES PLAINES, IL IN THE CHEMICAL
DISINFECTION TABLET 60018 DISINFECTION OF
SOFT (HYDROPHILIC)
CONTACT LENSES
P940007 MODEL WS-100 PHARMACIA, INC. INDICATED FOR PRIMARY
07/20/95 PLIOLENS DUBLIN, OH IMPLANTATION FOR
ULTRAVIOLET- 43017 VISUAL CORRECTION OF
ABSORBING SILICONE APHAKIA IN PERSONS
POSTERIOR CHAMBER 60 YEARS OF AGE OR OLDER
INTRAOCULAR
LENS (IOL)
***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
N05798/S007 OXYCEL OXIDIZED BECTON DICKINSON CHANGE IN THE QUALITY
07/24/95 CELLULOSE AND COMPANY CONTROL PROCEDURES
FRANKLIN LAKES, NJ FOR
07417-1881 POST-STERILIZATION
LOTS OF OXYCEL
N17511/S010 HYSKON MEDISAN REVISED LABELING
07/18/95 HYSTEROSCOPY PHARMACEUTICALS, INC.
FLUID 32% (W/V) PARSIPPANY, NJ
DEXTRAN IN DEXTROSE 07054
N17511/S011 HYSKON MEDISAN USE OF A LAGARDE
07/18/95 HYSTEROSCOPY PHARMACEUTICALS, INC. STERILIZER TO
FLUID 32% (W/V) PARSIPPANY, NJ TEMERMINALLY STERILIZE
DEXTRAN IN DEXTROSE 07054 HYSKON HYSTEROSCOPY
FLUID, 32% (DEXTRAN 70)
IN 100ML TO 250ML
GLASS BOTTLE
N17679/S029 TETRAFILCON A COOPERVISION, INC. REDUCTION OF THE
07/28/95 HYDROPHILIC FAIRPORT, NY INCUBATION TIME OF
CONTACT LENS 14450 THE BIOLOGICAL
INDICATOR USED IN THE
LENS STERILIZATION
PROCESS TO
FORTY-EIGHT HOURS
P800049/S006 ANTERIOR & ALCON LABORATORIES, INC. EDUCTION IN BIOLOGICAL
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX INDICATOR INCUBATION TIME
INTRAOCULAR LENSES 76134-2099 FROM 7 TO 5 DAYS
P810001/S011 ANTERIOR & ALCON LABORATORIES, INC. REDUCTION IN BIOLOGICAL
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX INDICATOR INCUBATION TIME
INTRAOCULAR LENSES 76134-2099 FROM 7 TO 5 DAYS
P810002/S035 ST. JUDE MEDICAL ST. JUDE MEDICAL, INC. ALTERNATE SUPPLIER OF
07/31/95 MECHANICAL HEART ST. PAUL, MN THE PYROLITIC CARBON
VALVE 55117 LEAFLET & ORIFICE
COMPONENTS USED IN
THE ST. JUDE MEDICAL
MECHANICAL HEART VALVE
P810018/S034 ANTERIOR & ALCON LABORATORIES, INC. REDUCTION IN
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX BIOLOGICAL INDICATOR
INTRAOCULAR LENSES 76134-2099 INCUBATION TIME FROM
7 TO 5 DAYS
P810032/S047 ANTERIOR & ALCON LABORATORIES, INC. REDUCTION IN
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX BIOLOGICAL INDICATOR
INTRAOCULAR LENSES 76134-2099 INCUBATION TIME FROM
7 TO 5 DAYS
P820018/S061 AUTIMA/AURORA TELECRONICS, INC. ADDITION OF
07/12/95 CARDIAC PACING ENGLEWOOD, CO NON-INVASIVE
SYSTEM - REFLEX 80112 PROGRAMMED STIMULATION
DDD MODELS 8224 & (NIPS)
8223E, REFLEX
MODELS 8218 & 8220E,
& SIMPLEX MODEL 8232
PULSE GENERATORS
P820035/S013 ANTERIOR & ALCON LABORATORIES, INC. REDUCTION IN
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX BIOLOGICAL INDICATOR
INTRAOCULAR LENSES 76134-2099 INCUBATION TIME FROM
7 TO 5 DAYS
P820049/S061 MODEL PC-10 PMMA ALLERGAN MEDICAL OPTICS SINGLE-POUCH TYVEK
07/28/95 POSTERIOR CHAMBER IRVINE, CA PACKAGING OF LENSES,
INTRAOCULAR LENS 92718 STERILIZATION OF
(IOL) LENSES USING
PREVIOUSLY
APPROVED 100% ETO
STERILIZATION CYCLES
& A 5 YEAR SHELF LIFE
P830040/S024 ANTERIOR & ALCON LABORATORIES, INC. REDUCTION IN
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX IOLOGICAL INDICATOR
INTRAOCULAR LENSES 76134-2099 INCUBATION TIME FROM
7 TO 5 DAYS
P830066/S012 ABBOTT CEA-RIA ABBOT LABORATORIES MODIFICATION OF THE
07/12/95 MONOCLONAL ABBOTT PARK, IL PACKAGE LABELING TO
60064-3500 DECREASE THE "HOOK"
VALUE FROM 100,000 TO
60,000NG CEA/ML
P830079/S011 INSTAT* COLLAGEN JOHNSON & JOHNSON APPROVAL TO MARKET
07/07/95 ABSORBABLE HEMOSTAT MEDICAL, INC. INSTAT COLLAGEN
ARLINGTON, TX ABSORBABLE HEMOSTAT
76004-3130 (ALL SIZES) FOR
ENDOSCOPIC PROCEDURES
P840001/S036 MEDTRONIC NEURO MEDTRONIC NEUROLOGICAL RELOCATION OF THE
07/13/95 MODELS:7491, 7492, MINNEAPOLIS, MN STERILIZATION/PACKAGING
7493, 7494, 7495, 55440-9087 FACILITY & A
& 7496 EXTENSIONS MODIFICATION IN THE
STERILIZATION PROCESS
P840024/S028 NUCLEUS 22 COCHLEAR CORPORATION NUCLEUS 22
07/28/95 CHANNEL COCHLEAR ENGLEWOOD, CO CHANNEL COCHLEAR
IMPLANT FOR 80112 IMPLANT FOR
PRELINGUISTICALLY PRELINGUISTICALLY
AND AND
PERILINGUISTICALLY PERILINGUISTICALLY
DEAFENED ADULTS DEAFENED ADULTS
P840060/S023 ANTERIOR & ALCON LABORATORIES, INC. REDUCTION IN
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX BIOLOGICAL INDICATOR
INTRAOCULAR LENSES 76134-2099 INCUBATION TIME FROM
TO 5 DAYS
P850021/S030 AMERICAN EDWARDS BAXTER HEALTHCARE MANUFACTURING
07/12/95 LAB., HYBRID CORPORATION MODIFICATION TO THE
PERCUTANEOUS SANTA ANA, CA INNER BODY OF THE
TRANSLUMINAL 92711-1150 ABOVE CATHETERS
CORONARY ANGIOPLASTY
CATHETER, REACH.14,
LONG REACH 30MM &
40MM, & READY .14
PTCA CATHETERS
P850029/S001 ABBOTT ER-EIA ABBOTT LABORATORIES MINOR LABELING
07/12/95 MONOCLONAL ABBOTT PARK, IL CHANGES TO ASSIST
60064-3500 USERS IN AVOIDING
INTERFERENCE BY
METHYLENE BLUE &
SIMILAR DYES
P860034/S012 MODELS AC-21 & ALLERGAN MEDICAL OPTICS SINGLE-POUCH TYVEK
07/28/95 AC-21B IRVINE, CA PACKAGING OF LENSES,
ANTERIOR CHAMBER 92718 STERILIZATION OF
INTRAOCULAR LENSES LENSES USING
PREVIOUSLY
APPROVED 100% ETO
STERILIZATION CYCLES
& A 5 YEAR SHELF LIFE
P860047/S010 OCUCOAT STORZ OPHTHALMICS, INC. CHANGE IN LABELING
07/18/95 VISCOELASTIC FLUID CLEARWATER, FL
34619
P870018/S010 LITHOSTAR SIEMENS MEDICAL MODIFIED IMAGE
07/13/95 LITHOTRIPTER FOR SYSTEMS, INC. INTENSIFIER TO BE
RENAL STONES ISELIN, NJ USED WITH THE
08830 LITHOSTAR SYSTEM
P870054/S014 KELVIN MODEL 513 COOK PACEMAKER CHANGE IN ACCELERATED
07/12/95 UNIPOLAR & CORPORATION BURN-IN PROCEDURE ON
MODEL 514 BIPOLAR LEECHBURG, PA THE LITHIUM/IODINE
CARDIAC 15656-0529 POWER SOURCE (BATTERY)
PULSE GENERATORS BY THE VENDOR
P880010/S017 ANTERIOR & ALCON LABORATORIES, INC. REDUCTION IN
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX BIOLOGICAL INDICATOR
INTRAOCULAR LENSES 76134-2099 INCUBATION TIME FROM
7 TO 5 DAYS
P880027/S037 SCHNEIDER SCHNEIDER (USA), INC. ADDITIONAL QUARTER
07/31/95 MICROSOFTRAC PTCA MINNEAPOLIS, MN SIZE MODELS OF THE MC
CATHETER, 55442 RAIL, MYSTIC, AND
SCHNEIDER MC RAIL FREEHAND CATHETER
20/30/40, MYSTIC LINES
20/30/40 MC, AND
FREEHAND PTCA
CATHETERS
P880072/S021 MODEL PA36E-OUV MEDICAL DEVELOPMENTAL PA36E-OUV
07/28/95 ULTRAVIOLET- RESEARCH, INC.
ABSORBING ST. PETERSBURG, FL
POSTERIOR CHAMBER 33716
INTRAOCULAR LENS
(IOL)
P880072/S026 MODELS GS55A-OUV MEDICAL DEVELOPMENTAL NEW MODELS:
07/24/95 & GS55B-OUV RESEARCH, INC. GS551A-OUV AND
ULTRAVIOLET- ST. PETERSBURG, FL GS55B-OUV AS TIER A
ABSORBING 33716 MODIFICATIONS OF
POSTERIOR CHAMBER MDL PA90E-2UV & FOR
INTRAOCULAR IMPLANTATION IN THE
LENSES (IOLS) CAPSULAR BAG ONLY
P880072/S027 MODELS LP50A-OUV, MEDICAL DEVELOPMENTAL TIER A MODIFICATIONS
07/24/95 PBO6B-OUV, & RESEARCH, INC. OF A PREVIOUSLY
PBO5A-OUV ST. PETERSBURG, FL APPROVED MEDICAL
ULTRAVIOLET- 33716 DEVELOPMENTAL
ABSORBING RESEARCH, INC.,
POSTERIOR CHAMBER PARENT IOL
INTRAOCULAR
LENSES (IOLS)
P880072/S028 MODELS LP50A-OUV, MEDICAL DEVELOPMENTAL TIER A MODIFICATIONS
07/24/95 PB06B-OUV, & RESEARCH, INC. OF A PREVIOUSLY
PBO5A-OUV ST. PETERSBURG, FL APPROVED MEDICAL
ULTRAVIOLET- 33716 DEVELOPMENTAL
ABSORBING RESEARCH, INC.,
POSTERIOR CHAMBER PARENT IOL
INTRAOCULAR
LENSES (IOLS)
P880072/S029 MODIFIED J & C MEDICAL DEVELOPMENTAL TIER A POSTERIOR
07/24/95 LOOP MODEL PA36 RESEARCH, INC. CHAMBER INTRAOCULAR
POSTERIOR CHAMBER ST. PETERSBURG, FL LENS MODEL RM60D-2UV
INTRAOCULAR LENS 33716
P880072/S032 MODELS LP50A-OUV, MEDICAL DEVELOPMENTAL TIER A MODIFICATIONS
07/24/95 PB06B-OUV, & RESEARCH, INC. OF A PREVIOUSLY
PB05A-OUV ST. PETERSBURG, FL APPROVED MEDICAL
ULTRAVIOLET- 33716 DEVELOPMENTAL
ABSORBING RESEARCH INC.,
POSTERIOR CHAMBER PARENT IOL
INTRAOCULAR
LENSES (IOLS)
P880072/S033 MODIFIED J & C MEDICAL DEVELOPMENTAL TIER A POSTERIOR
07/24/95 LOOP MODEL PA36 RESEARCH, INC. CHAMBER INTRAOCULAR
POSTERIOR CHAMBER ST. PETERSBURG, FL LENS MODEL CS55B-OUV
INTRAOCULAR LENS 33716
P880081/S018 MODELS SI-18B & ALLERGAN MEDICAL SINGLE-POUCH TYVEK
07/28/95 SI-18NB OPTICS PACKAGING OF LENSES,
ULTRAVIOLET- IRVINE, CA STERILIZATION OF
ABSORBING SILICONE 92718 LENSES USING
POSTERIOR CHAMBER PREVIOUSLY APPROVED
IOLS 100% ETO
STERILIZATION CYCLES
& A 5 YEAR SHELF LIFE
P880087/S005 ANTERIOR AND ALCON LABORATORIES, INC. REDUCTION IN
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX BIOLOGICAL INDICATOR
INTRAOCULAR LENSES 76134-2099 INCUBATION TIME FROM
7 TO 5 DAYS
P890003/S036 MODEL 979OC MEDTRONIC, INC. UPDATED CONFIGURATION
07/31/95 PROGRAMMER AND MINNEAPOLIS, MN OF THE MODEL 979OC
MODEL 9877E 55432-3576 PROGRAMMER, & UPDATED
BASELINE SOFTWARE BASELINE OPERATING
SOFTWARE MODEL 9877E
P890043/S028 SIMPSON CORONARY DEVICES FOR VASCULAR ADDITION OF
07/12/95 ATHEROCATH INTERVENTION, INC. MANUFACTURING SITE
REDWOOD CITY, CA AT TEMECULA, CA
94063
P890045/S001 GELSEAL TRIAXIAL CARBOMEDICS, INC. APPLICATION OF
07/05/95 VASCULAR GRAFT AUSTIN, TX GELATIN COATING TO
78752-1793 VASCUSOFT, A
DIFFERENT SUBSTRATE
GRAFT. TRADE
NAME: VASCUTEK GELSOFT
VASCULAR GRAFT
P890056/S002 MODEL PC-28LB ALLERGAN MEDICAL OPTICS SINGLE-POUCH TYVEK
07/28/95 PMMA POSTERIOR IRVINE, CA PACKAGING OF LENSES,
CHAMBER IOLS 92718 STERILIZATION OF
LENSES USING
PREVIOUSLY APPROVED
100% ETO
STERILIZATION CYCLES
& A 5 YEAR SHELF LIFE
P900009/S001 SONIC ACCELERATED EXOGEN, INC. SUPPLEMENTARY
07/07/95 FRACTURE HEALING PISCATAWAY, NJ REFERENCES FOR
SYSTEM (SAFHS) 08855 PHYSICIAN
MODEL 2A INSTALLATION AND
PATIENT USE OF THE
SAFHS MODEL 2A DEVICE
P900013/S001 ABBOTT PGR-EIA ABBOTT LABORATORIES MINOR LABELING
07/07/95 MONOCLONAL ABBOTT PARK, IL CHANGES TO ASSIST
60064-3500 USERS IN AVOIDING
INTERFERENCE BY
METHYLENE BLUE AND
SIMILAR DYES
P900056/S006 ROTABLATOR HEART TECHNOLOGY, INC. RELOCATION OF
07/12/95 ROTATIONAL REDMOND, WA MANUFACTURING
ANGIOPLASTY SYSTEM 98052-3376 FACILITY TO
REDMOND, WA
P900059/S001 ALBUNEX MOLECULAR BIOSYSTEMS, INC. TWO TRAINING VIDEOS
07/31/95 ULTRASOUND CONTRAST SAN DIEGO, CA
MICROSPHERES 92121-2789
P900070/S007 META DDDR CARDIAC TELECRONICS, INC ADDITION OF
07/12/95 PACING SYSTEM ENGLEWOOD, CO NON-INVASIVE
80112 PROGRAMMED STIMULATION
(NIPS)
P910001/S005 SPECTRANETICS SPECTRANETICS, INC. VITESSE-E
07/31/95 CVX-300 EXCIMER COLORADO SPRINGS, CO (MODEL 117-005) AND
LASER SYSTEM 80907-5159 VITESSE-E II
(MODEL 117-205) CATHETERS
USED WITH THE CVX-300
EXCIMER LASER SYSTEM
ON ECCENTRIC LESIONS
P910001/S008 SPECTRANETICS SPECTRANETICS CORPORATION UPGRADED SOFTWARE
07/12/95 CVX-300 EXCIMER COLORADO SPRINGS, CO (VERSION 3.4) FOR THE
LASER SYSTEM 80907 SPECTRANETICS CVX-300
EXCIMER LASER SYSTEM
P910064/S001 REALITY FEMALE WISCONSIN PHARMACAL COMPANY ACCELERATED AND
07/24/95 CONDOM CHICAGO, IL REAL-TIME AGING
60611 STUDIES TO ESTABLISH
A NEW SHELF LIFE
P910064/S004 REALITY FEMALE WISCONSIN PHARMACAL COMPANY ADDITIONAL DATA ON IN
07/24/95 CONDOM CHICAGO, IL VITRO BARRIER
60611 PROPERTIES W/RESPECT
TO SEXUALLY
TRANSMITTED DISEASES
PER FDA'S 5/7/93
LTR CONTAINING
CONDITIONS OF APPROVAL
P910064/S006 REALITY FEMALE WISCONSIN PHARMACAL COMPANY FOCUS GROUP STUDY
07/24/95 CONDOM CHICAGO, IL PROTOCOL TO ASSESS
60611 PATIENT COMPREHENSION
OF PRODUCT LABELING
P910064/S007 REALITY FEMALE WISCONSIN PHARMACAL COMPANY CHANGE PROFESSIONAL
07/31/95 CONDOM CHICAGO, IL MONOGRAPH & PATIENT
60611 LABELING TO INCLUDE
INFORMATION FOR
CONCOMITANT USE OF
SPERMICIDE CONTAINING
NONOXYNOL-9 W/REALITY
FEMALE CONDOM
P910064/S008 REALITY FEMALE WISCONSIN PHARMACAL COMPANY EXTENSION OF PRODUCT
07/31/95 CONDOM CHICAGO, IL SHELF LIFE
60611
P910064/S009 REALITY FEMALE WISCONSIN PHARMACAL COMPANY ADDITIONAL DATA ON
07/24/95 CONDOM CHICAGO, IL THE IN VITRO BARRIER
60611 PROPERTIES W/RESPECT
TO SEXUALLY
TRANSMITTED DISEASES
PER FDA'S 5/7/93
LTR CONTAINING
CONDITIONS OF APPROVAL
P910064/S010 REALITY FEMALE WISCONSIN PHARMACAL COMPANY EXTENSION OF PRODUCT
07/31/95 CONDOM CHICAGO, IL SHELF LIFE
60611
P910071/S002 ADATOSIL 5000 CHIRON VISION CORPORATION PROTOCOL FOR A
07/14/95 IRVINE, CA POSTAPPROVAL
92718-1903 PROSPECTIVE STUDY
P930014/S001 ANTERIOR & ALCON LABORATORIES, INC. REDUCTION IN
07/24/95 POSTERIOR CHAMBER FORT WORTH, TX BIOLOGICAL INDICATOR
INTRAOCULAR LENSES 76134-2099 INCUBATION TIME FROM
7 TO 5 DAYS
***ORIGINAL VETERINARY NADAs***
THERE ARE NO ORIGINAL VETERINARY NADAs FOR JULY 1995.
***ORIGINAL ABBREVIATED VETERINARY NADAs***
THERE ARE NO ORIGINAL ABBREVIATED VETERINARY NADAs FOR JULY 1995.
***SUPPLEMENTAL VETERINARY NADAs***
139-236 ANASED CATS LLOYD XYLAZINE HYDROCHLORIDE
16-MAY-95 (INJECTABLE) SHENANDOAH, IA EQ 20MG BASE/ML
51601
139-236 ANASED CERVIDAE LLOYD XYLAZINE HYDROCHLORIDE
16-MAY-95 (INJECTABLE) SHENANDOAH, IA EQ 100MG BASE/ML
51601
Date created: October 30, 1996; last updated: June 20, 2005 |
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