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Drug and Device Product Approvals for April 1996 ***ORIGINAL AND SUPPLEMENTAL NDAs***
FOR NEW DRUG PRODUCTS
19-537 CIPRO BAYER CIPROFLOXACIN HYDROCHLORIDE
08-APR-96 (TABLET) WEST HAVEN, CT EQ 100MG BASE
(SUPPL-026) 06516 EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
(NEW INDICATION --
TREATMENT OF ACUTE
UNCOMPLICATED CYSTITIS
IN FEMALES)
20-406 PREVACID TAP HOLDINGS LANSOPRAZOLE
08-APR-96 (CAPSULE, DEERFIELD, IL 15MG
(SUPPL-002) DELAYED RELEASE) 60015 30MG
GRANULES (NEW INDICATION --
MAINTENANCE OF
HEALING
OF EROSIVE
ESOPHAGITIS)
50-704 DAUNOXOME NEXSTAR DAUNORUBICIN CITRATE
08-APR-96 (INJECTABLE, SAN DIMAS, CA EQ 2MG BASE/ML
(3 P, AA*, LIPOSOMAL) 91773 (ANTINEOPLASTIC)
V**) [FIRST LINE
CYTOTOXIC
THERAPY FOR ADVANCED HIV
RELATED KAPOSI'S SARCOMA]
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
15-APR-96 (CAPSULE, WAYNE, PA 10MG
(SUPPL-037) DELAYED RELEASE) 19087 20MG
GRANULES (NEW INDICATION --
COMBINATION THERAPY WITH
CLARITHROMYCIN TO ERADICATE
HELICOBACTER PYLORI TO
REDUCE THE RISK OF DUODENAL
ULCER RECURRENCE)
AA* - Priority Classification AIDS Drug
V** - Designated Orphan Drug
20-670 MONISTAT-3 ADV CARE MICONAZOLE NITRATE
16-APR-96 COMBINATION PACK RARITAN, NJ 2% CREAM
(6 S) (CREAM/ 08869 200MG SUPPOSITORY
SUPPOSITORY) (ANTIFUNGAL)
[TREATMENT OF VULVOVAGINAL
CANDIDIASIS]
(OTC)
50-662 BIAXIN ABBOTT CLARITHROMYCIN
18-APR-96 (TABLET) ABBOTT PARK, IL 250MG
(SUPPL-010) 60064 500MG
(NEW INDICATION --
COMBINATION THERAPY WITH
OMEPRAZOLE FOR THE
TREATMENT OF PATIENTS WITH
AN ACTIVE DUODENAL ULCER
ASSOCIATED WITH
HELICOBACTER PYLORI)
18-731 BUSPAR BRISTOL MYERS BUSPIRONE HYDROCHLORIDE
22-APR-96 (TABLET) SQUIBB 5MG
(SUPPL-031) WALLINGFORD, CT 10MG
06492 15MG
30MG***
(NEW DOSAGE REGIMEN --
DOSING SCHEDULE CHANGED
TO BID AND INITIAL DOSE
CHANGED TO 7.5MG)
20-472 ESTRING PHARMACIA ESTRADIOL
26-APR-96 (INSERT, COLUMBUS, OH 0.0075MG/24HR
(3 S) EXTENDED RELEASE) 43216 (ESTROGEN)
[TREATMENT OF UROGENITAL
SYMPTOMS ASSOCIATED WITH
POST-MENOPAUSAL ATROPHY
OF THE VAGINA AND/OR THE
LOWER URINARY TRACT]
20-528 MAVIK KNOLL PHARM TRANDOLAPRIL
26-APR-96 (TABLET) MOUNT OLIVE, NJ 1MG
(1 S) 07828 2MG
4MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
[TREATMENT OF HYPERTENSION]
20-344 REDUX INTERNEURON DEXFENFLURAMINE
29-APR-96 (CAPSULE) LEXINGTON, MA HYDROCHLORIDE
(3 S) 02173 15MG
(SEROTONIN REUPTAKE
INHIBITOR/RELEASING AGENT)
[MANAGEMENT OF OBESITY]
*** - Not Marketed At This Time
20-573 BUPHENYL UCYCLYD SODIUM PHENYLBUTYRATE
30-APR-96 (POWDER) HUNT VALLEY, MD 3GM/TEASPOONFUL
(1 P, V**) 21031 (HYPERAMMONENMIA AGENT)
[MANAGEMENT OF CHRONIC UREA
CYCLE DISORDERS]
V** - Designated Orphan Drug
***APPROVABLE ORIGINAL NDAs***
An approvable letter indicates that FDA is prepared to approve the application
upon the satisfaction of conditions specified in the approvable letter.
Drug products which are the subject of approvable letters may not be legally
marketed until the firm has satisfied the identified deficiencies, as well as
any other requirements that may be imposed by FDA, and has been notified in
writing that the application has been approved. Further information on
approvable NDAs is not subject to Freedom of Information (FOI) release until
applications are approved.
20-524 BUTENAFINE HCL PENEDERM BUTENAFINE HYDROCHLORIDE
03-APR-96 (CREAM) FOSTER CITY, CA 1%
94404 (ANTIFUNGAL)
20-511 APHTHASOL BLOCK DRUG AMLEXANOX
16-APR-96 (PASTE) JERSEY CITY, NJ 5%
07302 (ANTI-INFLAMMATORY)
19-764 SAIZEN SERONO LABS SOMATROPIN, BIOSYNTHETIC
22-APR-96 (INJECTABLE) NORWELL, MA 5MG/VIAL
02061 10MG/VIAL
(HUMAN GROWTH HORMONE)
20-589 CHILDREN'S ADVIL WHITEHALL LABS IBUPROFEN
25-APR-96 (SUSPENSION) MADISON, NJ 100MG/5ML
07940 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
20-602 JUNIOR STRENGTH MCNEIL IBUPROFEN
25-APR-96 MOTRIN FT WASHINGTON, PA 100MG
(TABLET) 19034 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
20-603 CHILDREN'S MOTRIN MCNEIL IBUPROFEN
25-APR-96 (SUSPENSION) FT WASHINGTON, PA 40MG/ML
19034 (NONSTEROIDAL
ANTI-INFLAMMATORY)
(OTC)
20-591 TARKA KNOLL PHARM TRANDOLAPRIL
26-APR-96 (TABLET) MOUNT OLIVE, NJ 2MG
07828 (ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
VERAPAMIL HYDROCHLORIDE
180MG
(CALCIUM CHANNEL BLOCKER)
20-591 TARKA KNOLL PHARM TRANDOLAPRIL
26-APR-96 (TABLET) MOUNT OLIVE, NJ 4MG
07828 (ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
VERAPAMIL HYDROCHLORIDE
240MG
(CALCIUM CHANNEL BLOCKER)
***ORIGINAL ABBREVIATED NDAs***
20-345* AMINOSYN-HF 8% ABBOTT AMINO ACIDS
04-APR-96 (INJECTABLE) ABBOTT PARK, IL 8%
60064 (NUTRIENT REPLENISHER)
20-360* HEPATASOL 8% BAXTER AMINO ACIDS
04-APR-96 (INJECTABLE) ROUND LAKE, IL 8%
60073 (NUTRIENT REPLENISHER)
74-588* MINOXIDIL BARRE MINOXIDIL
05-APR-96 (FOR MEN) BALTIMORE, MD 2%
(SOLUTION) 21224 (HAIR GROWTH STIMULANT)
74-589* MINOXIDIL LEMMON MINOXIDIL
05-APR-96 (FOR MEN) SELLERSVILLE, PA 2%
(SOLUTION) 18960 (HAIR GROWTH STIMULANT)
74-643 MINOXIDIL BAUSCH AND LOMB MINOXIDIL
09-APR-96 (FOR MEN) TAMPA, FL 2%
(SOLUTION) 33637 (HAIR GROWTH STIMULANT)
73-667 NORTRIPTYLINE HCL BIOCRAFT NORTRIPTYLINE HYDROCHLORIDE
11-APR-96 (CAPSULE) FAIR LAWN, NJ EQ 10MG BASE
07410 EQ 25MG BASE
EQ 50MG BASE
EQ 75MG BASE
(ANTIDEPRESSANT)
74-216 NAPROXEN BIOCRAFT NAPROXEN
11-APR-96 (TABLET) FAIR LAWN, NJ 250MG
07410 375MG
500MG
(NONSTEROIDAL
ANTI-INFLAMMATORY)
40-157 HYDROCODONE VINTAGE PHARMS ACETAMINOPHEN
12-APR-96 BITARTRATE AND CHARLOTTE, NC 750MG
ACETAMINOPHEN 28206 HYDROCODONE BITARTRATE
(TABLET) 7.5MG
(ANALGESIC)
40-086* UNIPHYL PURDUE FREDERICK THEOPHYLLINE
15-APR-96 (TABLET, NORWALK, CT 600MG
EXTENDED RELEASE) 06850 (BRONCHODILATOR)
* - First Time Product Available Generically
40-118* CARISOPRODOL, EON LABS ASPIRIN
16-APR-96 ASPIRIN AND LAURELTON, NY 325MG
CODEINE PHOSPHATE 11413 CARISOPRODOL
(TABLET) 200MG
CODEINE PHOSPHATE
16MG
(ANALGESIC/
SKELETAL MUSCLE RELAXANT)
74-576 CAPTOPRIL CHELSEA LABS CAPTOPRIL
23-APR-96 (TABLET) CINCINNATI, OH 12.5MG
45215 25MG
50MG
100MG
(ANGIOTENSIN CONVERTING
ENZYME INHIBITOR)
40-092* DIGOXIN PEDIATRIC SANOFI WINTHROP DIGOXIN
25-APR-96 (INJECTABLE) NEW YORK, NY 0.1MG/ML
10016 (ANTIARRHYTHMIC/
CARDIOTONIC)
40-116 CARISOPRODOL EON LABS ASPIRIN
25-APR-96 AND ASPIRIN LAURELTON, NY 325MG
(TABLET) 11413 CARISOPRODOL
200MG
(ANALGESIC/
SKELETAL MUSCLE RELAXANT)
74-428 CIMETIDINE HCL MOVA CIMETIDINE HYDROCHLORIDE
25-APR-96 (INJECTABLE) CAGUAS, PR EQ 300MG BASE/2ML
00755 (HISTAMINE H-2 RECEPTOR
ANTAGONIST)
40-119 ACETAMINOPHEN AND HI TECH PHARMA ACETAMINOPHEN
26-APR-96 CODEINE PHOSPHATE AMITYVILLE, NY 120MG/5ML
(SOLUTION) 11701 CODEINE PHOSPHATE
12MG/5ML
(ANALGESIC)
73-531 POTASSIUM CHLORIDE BIOCRAFT POTASSIUM CHLORIDE
26-APR-96 (CAPSULE, ELMWOOD PARK, NJ 8MEQ
EXTENDED RELEASE) 07407 (ELECTROLYTE REPLACEMENT)
73-532 POTASSIUM CHLORIDE BIOCRAFT POTASSIUM CHLORIDE
26-APR-96 (CAPSULE, FAIR LAWN, NJ 10MEQ
EXTENDED RELEASE) 07410 (ELECTROLYTE REPLACEMENT)
* - First Time Product Available Generically
74-026 TRIAMTERENE AND SIDMAK LABS NJ HYDROCHLOROTHIAZIDE
26-APR-96 HYDROCHLOROTHIAZIDE EAST HANOVER, NJ 25MG
(TABLET) 07936 TRIAMTERENE
37.5MG
(DIURETIC)
74-299*+ INDAPAMIDE ZENITH GOLDLINE INDAPAMIDE
29-APR-96 (TABLET) NORTHVALE, NJ 1.25MG
07647 (NEW STRENGTH)
* - First Time Product Available Generically
+ - Supplemental Abbreviated NDA
***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 APRIL 1996.
***LABELING SUPPLEMENTS TO ORIGINAL NDAs***
20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL
01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML
06492 (LABELING REVISION --
BOXED WARNING;
DESCRIPTION; WARNINGS;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE
02-APR-96 (TABLET) KANSAS CITY, MO 30MG
64134 60MG
90MG
120MG
(LABELING REVISION --
WARNINGS;
ADVERSE REACTIONS;
OVERDOSAGE)
19-951 RETROVIR GLAXO WELLCOME ZIDOVUDINE
02-APR-96 (INJECTABLE) RES TRIANGLE PK, NC 10MG/ML
27709 (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION)
20-027 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE
02-APR-96 (INJECTABLE) KANSAS CITY, MO 5MG/ML
64134 25MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
20-033 LOTENSIN HCT CIBA BENAZEPRIL HYDROCHLORIDE
02-APR-96 (TABLET) SUMMIT, NJ 5MG
07901 HYDROCHLOROTHIAZIDE
6.25MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
20-033 LOTENSIN HCT CIBA BENAZEPRIL HYDROCHLORIDE
02-APR-96 (TABLET) SUMMIT, NJ 10MG
07901 HYDROCHLOROTHIAZIDE
12.5MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
20-033 LOTENSIN HCT CIBA BENAZEPRIL HYDROCHLORIDE
02-APR-96 (TABLET) SUMMIT, NJ 20MG
07901 HYDROCHLOROTHIAZIDE
12.5MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
20-033 LOTENSIN HCT CIBA BENAZEPRIL HYDROCHLORIDE
02-APR-96 (TABLET) SUMMIT, NJ 20MG
07901 HYDROCHLOROTHIAZIDE
25MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
20-062 CARDIZEM CD CARDERM DILTIAZEM HYDROCHLORIDE
02-APR-96 (CAPSULE, HAMILTON, BERMUDA 120MG
EXTENDED RELEASE) 180MG
240MG
300MG
(LABELING REVISION --
WARNINGS;
ADVERSE REACTIONS;
OVERDOSAGE)
17-892 HALCION UPJOHN TRIAZOLAM
04-APR-96 (TABLET) KALAMAZOO, MI 0.125MG
49001 0.25MG
(LABELING REVISION --
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS;
PATIENT PACKAGE INSERT)
18-584 BECONASE GLAXO WELLCOME BECLOMETHASONE DIPROPIONATE
04-APR-96 (AEROSOL, METERED) RES TRIANGLE PK, NC 0.042MG/INH
27709 (LABELING REVISION --
PRECAUTIONS;
ADVERSE REACTIONS)
50-668 LORABID LILLY LORACARBEF
05-APR-96 (CAPSULE) INDIANAPOLIS, IN 200MG
46285 400MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
16-099 ATROMID-S WYETH AYERST CLOFIBRATE
08-APR-96 (CAPSULE) PHILADELPHIA, PA 500MG
19101 (LABELING REVISION --
WARNINGS; PRECAUTIONS;
ADVERSE REACTIONS)
19-537 CIPRO BAYER CIPROFLOXACIN HYDROCHLORIDE
08-APR-96 (TABLET) WEST HAVEN, CT EQ 100MG BASE
06516 EQ 250MG BASE
EQ 500MG BASE
EQ 750MG BASE
(LABELING REVISION --
INDICATIONS AND USAGE)
20-406 PREVACID TAP HOLDINGS LANSOPRAZOLE
08-APR-96 (CAPSULE, DEERFIELD, IL 15MG
DELAYED RELEASE 60015 30MG
GRANULES) (LABELING REVISION --
INDICATIONS AND USAGE)
18-920* MVI PEDIATRIC ASTRA ASCORBIC ACID
09-APR-96 (INJECTABLE) WESTBOROUGH, MA 80MG/VIAL
01581 BIOTIN
20MCG/VIAL
CYANOCOBALAMIN
1MCG/VIAL
DEXPANTHENOL
5MG/VIAL
ERGOCALCIFEROL
10MCG/VIAL
FOLIC ACID
140MCG/VIAL
NIACINAMIDE
17MG/VIAL
PHYTONADIONE
200MCG/VIAL
PYRIDOXINE HYDROCHLORIDE
EQ 1MG BASE/VIAL
RIBOFLAVIN PHOSPHATE SODIUM
EQ 1.4MG BASE/VIAL
THIAMINE HYDROCHLORIDE
EQ 1.2MG BASE/VIAL
VITAMIN A
0.7MG/VIAL
VITAMINE E
7MG/VIAL
(LABELING REVISION --
ADVERSE REACTIONS)
16-832 CYLERT ABBOTT PEMOLINE
11-APR-96 (TABLET) ABBOTT PARK, IL 18.75MG
60064 37.5MG
75MG
(LABELING REVISION --
OVERDOSAGE)
17-703 CYLERT ABBOTT PEMOLINE
11-APR-96 (TABLET, CHEWABLE) ABBOTT PARK, IL 37.5MG
60064 (LABELING REVISION --
OVERDOSAGE)
* - Not Marketed At This Time
19-885 ACCUPRIL PARKE DAVIS QUINAPRIL HYDROCHLORIDE
12-APR-96 (TABLET) MORRIS PLAINS, NJ EQ 5MG BASE
07950 EQ 10MG BASE
EQ 20MG BASE
EQ 40MG BASE
(LABELING REVISION --
INDICATIONS AND USAGE;
WARNINGS;
ADVERSE REACTIONS)
09-053 PURINETHOL GLAXO WELLCOME MERCAPTOPURINE
15-APR-96 (TABLET) RES TRIANGLE PK, NC 50MG
27709 (LABELING REVISION --
WARNINGS)
19-810 PRILOSEC ASTRA MERCK OMEPRAZOLE
15-APR-96 (CAPSULE, WAYNE, PA 10MG
DELAYED RELEASE 19087 20MG
GRANULES) (LABELING REVISION --
CLINICAL PHARMACOLOGY;
INDICATIONS AND USAGE;
CONTRAINDICATIONS;
PRECAUTIONS;
ADVERSE REACTIONS;
DOSAGE AND ADMINISTRATION)
19-084 NIZORAL JANSSEN KETOCONAZOLE
16-APR-96 (CREAM) TITUSVILLE, NJ 2%
08569 (LABELING REVISION --
ADVERSE REACTIONS)
19-453 DRIXORAL SCHERING PLOUGH ACETAMINOPHEN
16-APR-96 (TABLET, MEMPHIS, TN 500MG
EXTENDED RELEASE) 38151 DEXBROMPHENIRAMINE MALEATE
3MG
PSEUDOEPHEDRINE SULFATE
60MG
(LABELING REVISION --
PATIENT LABELING)
(OTC)
19-576 NIZORAL JANSSEN KETOCONAZOLE
16-APR-96 (CREAM) TITUSVILLE, NJ 2%
08569 (LABELING REVISION --
ADVERSE REACTIONS)
19-648 NIZORAL JANSSEN KETOCONAZOLE
16-APR-96 (CREAM) TITUSVILLE, NJ 2%
08569 (LABELING REVISION --
ADVERSE REACTIONS)
18-276 XANAX UPJOHN ALPRAZOLAM
18-APR-96 (TABLET) KALAMAZOO, MI 0.25MG
49001 0.5MG
1MG
2MG
(LABELING REVISION --
CLINICAL PHARMACOLOGY;
CONTRAINDICATIONS;
WARNINGS; PRECAUTIONS)
50-662 BIAXIN ABBOTT CLARITHROMYCIN
18-APR-96 (TABLET) ABBOTT PARK, IL 250MG
60064 500MG
(LABELING REVISION --
INDICATIONS AND USAGE)
20-280 GENOTROPIN PHARMACIA SOMATROPIN, BIOSYNTHETIC
19-APR-96 (INJECTABLE) COLUMBUS, OH 1.5MG/VIAL
43216 5.8MG/VIAL
(LABELING REVISION --
HOW SUPPLIED)
18-731 BUSPAR BRISTOL MYERS SQUIBB BUSPIRONE HYDROCHLORIDE
22-APR-96 (TABLET) WALLINGFORD, CT 5MG
06492 10MG
15MG
30MG*
(LABELING REVISION --
DESCRIPTION;
ADVERSE REACTIONS;
OVERDOSAGE;
DOSAGE AND
ADMINISTRATION;
HOW SUPPLIED)
19-279 DIMETANE WYETH AYERST BROMPHEMIRAMINE MALEATE
22-APR-96 (SYRUP) PHILADELPHIA, PA 2MG/5ML
19101 DEXTROMETHORPHAN
HYDROBROMIDE
10MG/5ML
PSEUDOEPHEDRINE
HYDROCHLORIDE
30MG/5ML
(LABELING REVISION --
CONTRAINDICATIONS;
PRECAUTIONS)
* - Not marketed at this time
19-010 LUPRON TAP LEUPROLIDE ACETATE
24-APR-96 (INJECTABLE) DEERFIELD, IL 1MG/0.2ML
60015 (LABELING REVISION --
HOW SUPPLIED)
20-186 ZIAC LEDERLE BISOPROLOL FUMARATE
24-APR-96 (TABLET) PHILADELPHIA, PA 2.5MG
19101 HYDROCHLOROTHIAZIDE
6.25MG
(LABELING REVISION --
OVERDOSAGE)
20-186 ZIAC LEDERLE BISOPROLOL FUMARATE
24-APR-96 (TABLET) PHILADELPHIA, PA 5MG
19101 HYDROCHLOROTHIAZIDE
6.25MG
(LABELING REVISION --
OVERDOSAGE)
20-186 ZIAC LEDERLE BISOPROLOL FUMARATE
24-APR-96 (TABLET) PHILADELPHIA, PA 10MG
19101 HYDROCHLOROTHIAZIDE
6.25MG
(LABELING REVISION --
OVERDOSAGE)
19-927 NIZORAL JANSSEN KETOCONAZOLE
25-APR-96 (SHAMPOO) TITUSVILLE, NJ 2%
08569 (LABELING REVISION --
OVERDOSAGE)
50-708 PROGRAF FUJISAWA TACROLIMUS
25-APR-96 (CAPSULE) DEERFIELD, IL EQ 1MG BASE
60015 EQ 5MG BASE
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
50-709 PROGRAF FUJISAWA TACROLIMUS
25-APR-96 (INJECTABLE) DEERFIELD, IL EQ 5MG BASE/ML
60015 (LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
18-702 ACLOVATE GLAXO WELLCOME ALCLOMETASONE DIPROPIONATE
26-APR-96 (OINTMENT) RES TRIANGLE PK, NC 0.05%
27709 (LABELING REVISION --
CLASS LABELING UPDATE;
PRECAUTIONS)
18-707 ACLOVATE GLAXO WELLCOME ALCLOMETASONE DIPROPIONATE
26-APR-96 (CREAM) RES TRIANGLE PK, NC 0.05%
27709 (LABELING REVISION --
CLASS LABELING UPDATE;
PRECAUTIONS)
19-680 DEPAKOTE ABBOTT DIVALPROEX SODIUM
26-APR-96 (CAPSULE, ABBOTT PARK, IL EQ 125MG VALPROIC ACID
DELAYED RELEASE 60064 (LABELING REVISION --
PELLETS) SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-363 FAMVIR SMITHKLINE BEECHAM FAMCICLOVIR
26-APR-96 (TABLET) PHILADELPHIA, PA 125MG
19101 250MG
500MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
19-670 CLARITIN-D SCHERING LORATADINE
29-APR-96 (TABLET, KENILWORTH, NJ 5MG
EXTENDED RELEASE) 07033 PSEUDOEPHEDRINE SULFATE
120MG
(LABELING REVISION --
SECTION(S) OF LABELING
REVISED NOT SPECIFIED
IN APPROVAL LETTER)
20-364 LOTREL CIBA GEIGY AMLODIPINE BESYLATE
29-APR-96 (CAPSULE) SUMMIT, NJ EQ 2.5MG BASE
07901 BENAZEPRIL HYDROCHLORIDE
10MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
20-364 LOTREL CIBA GEIGY AMLODIPINE BESYLATE
29-APR-96 (CAPSULE) SUMMIT, NJ EQ 5MG BASE
07901 BENAZEPRIL HYDROCHLORIDE
10MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
20-364 LOTREL CIBA GEIGY AMLODIPINE BESYLATE
29-APR-96 (CAPSULE) SUMMIT, NJ EQ 5MG BASE
07901 BENAZEPRIL HYDROCHLORIDE
20MG
(LABELING REVISION --
INDICATIONS AND USAGE;
PRECAUTIONS;
ADVERSE REACTIONS)
10-799 DIMETAPP ALLERGY WHITEHALL BROMPHENIRAMINE MALEATE
30-APR-96 (TABLET, MADISON, NJ 12MG
EXTENDED RELEASE) 07940 (LABELING REVISION --
PATIENT LABELING)
(OTC)
***BIOLOGICAL PRODUCT LICENSES ISSUED***
1201 NONE CANGENE SOURCE PLASMA
02-APR-96 (INJECTABLE) WINNIPEG, MANITOBA (A,B)
CANADA
1138 REVERSE-CYTE DADE AG REAGENT RED BLOOD CELLS
03-APR-96 (INJECTABLE) SWITZERLAND (B)
0226 NONE BLOOD BANK PLATELETS
25-APR-96 (INJECTABLE) SAN BERNARDINO AND (B)
RIVERSIDE COUNTIES
SAN BERNARDINO, CA
92412
(A) Establishment License Issued
(B) Product License Issued
***BIOLOGICAL PRODUCT DEVICE APPROVALS***
BK960012 CYTO-THERM-S PHOTO THERM PLASMA THAWER
15-APR-96 TRENTON, NJ (C)
08610
BK960013 MTS CENTRIFUGE MICRO TYPING SYS CENTRIFUGE
15-APR-96 MODEL #9310 POMPANO BEACH, FL (C)
33069
BK950033 HAEMONETICS PCS2 HAEMONETICS APHERESIS HARDWARE
16-APR-96 BRAINTREE, MA AND DISPOSABLE COLLECTION
02184 SET
(C)
(C) Substantially Equivalent
***BIOLOGICAL PRODUCT NDA APPROVAL***
83-071508 PROMIT MEDISAN PHARMA DEXTRAN 1
15-APR-96 PARSIPPANY, NJ (D)
07054
(D) Approved
***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
P940005 ULTRAMARK 9 ADVANCED TECHNOLOGY AN ADJUNCT TO
04/11/96 HIGH DEFINITION LABORATORIES MAMMOGRAPHY AND PHYSICAL
IMAGING (HDI) BOTHELL, WA BREAST EXAMINATION, TO
ULTRASOUND SYSTEM 98041-3003 DIFFERENTIATE BENIGN
WITH L10-5 FROM MALIGNANT OR
SCANHEAD SUSPICIOUS BREAST
LESIONS
P940042 SOLO-CARE CIBA VISION CORP FOR CLEANING, RINSING,
04/25/96 DULUTH, GA DISINFECTING AND STORING
30136-1518 SOFT (HYDROPHILIC)
CONTACT LENSES AND FOR
DISSOLVING ENZYME
TABLETS
***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
N17786/S024 ALLERGAN ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 HYDROCARE IRVINE, CA STERILIZATION SITE,
CLEANING AND 92713-9534 ISOTRON IRELAND LTD.,
DISINFECTING OFFALY, IRELAND, AND
SOLUTION USE OF 100% ETHYLENE
OXIDE TO STERILIZE
PLASTIC BOTTLES,
TIPS, AND CAPS
N18020/S039 ALLERGAN HYDROCARE ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 PRESERVED SALINE IRVINE, CA STERILIZATION SITE,
SOLUTION, 92713-9534 ISOTRON IRELAND LTD.,
SORBICARE SALINE, OFFALY, IRELAND, AND
AND PRESERVED USE OF 100% ETHYLENE
SALINE OXIDE TO STERILIZE
PLASTIC BOTTLES,
TIPS, AND CAPS
N50510/S070 VITEK SYSTEMS BIOMERIEUX VITEK, INC ADDITION OF A
04/22/96 "GENERAL HAZELWOOD, MO LIMITATION STATEMENT
SUSCEPTIBILITY 63042-2395 REQUIRING AN ALTERNATE
CARD" METHOD OF TESTING FOR
PIPERACILIN IN
SUSCEPTIBILITY TESTING
OF PSEUDOMONAS
AERUGINOSA
P790002/S016 EBI BONE ELECTRO-BIOLOGY, INC LABELING CHANGES TO
04/09/96 HEALING SYSTEM PARSIPPANY, NJ PHYSICIAN INSTRUCTION
07054-1079 AND PATIENT MANUALS
P790017/S052 USCI GRUNTZIG, C.R. BARD, INC STERILIZATION SITE
04/18/96 FORCE, SPRINT, BILLERICA, MA CHANGE AND A CHANGE
AND SOLO BALLOON 01821 IN THE STERILIZATION
DILATATION CATHETER CYCLE
WITH PRO/PEL COATING
P790024/S024 EASYCLEAN/GP, ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 LC-65, LENS CLEAR, IRVINE, CA STERILIZATION SITE
AND LENS PLUS, 92715-9534 ISOTRON IRELAND LTD.,
DAILY CLEANERS OFFALY, IRELAND, AND USE
OF 100% ETHYLENE OXIDE
TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P800065/S014 LENS-WET ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 LUBRICATING AND IRVINE, CA STERILIZATION SITE
REWETTING SOLUTION 92713-9534 ISOTRON IRELAND LTD.,
AND LENS FRESH OFFALY, IRELAND, AND
LUBRICATING AND USE OF 100% ETHYLENE
REWETTING DROPS OXIDE TO STERILIZE
PLASTIC BOTTLES, TIPS,
AND CAPS
P820018/S067 AUTIMA/AURORA TELECTRONICS PACING APPROVAL FOR
04/23/96 CARDIAC PACING SYSTEMS SUBSTRATE DESIGN
SYSTEM ENGLEWOOD, CO CHANGES
80112
P830026/S064 COSMOS FAMILY INTERMEDICS, INC. ALTERNATE
04/01/96 OF PULSE GENERATORS ANGLETON, TX STERILIZATION PROCESS
77515
P830056/S075 POSTERIOR CHAMBER MENTOR CORP. APPROVAL FOR MODELS
04/02/96 INTRAOCULAR LENSES SANTA BARBARA, CA C420P, C540U, C445F,
(IOLS) 93111 C840U, U240F0, C540MC,
U211F, AND U241FO
POSTERIOR CHAMBER
INTRAOCULAR LENSES
VIA TIER A
P840008/S053 DORNIER DORNIER MEDICAL NEW MODEL LITHOTRIPTER
04/11/96 LITHOTRIPTER MOBILE SYSTEMS, INC. INDICATED FOR THE
KENNESAW, GA FRAGMENTATION OF 5 TO 25
30144 MILLIMETER KIDNEY STONES
SUCH AS RENAL CALYX AND
AND RENAL PELVIC STONES
P840024/S061 NUCLEUS 22 COCHLEAR CORP. MODIFICATIONS TO THE
04/04/96 CHANNEL COCHLEAR ENGLEWOOD, CO AUDIO INPUT SELECTOR
IMPLANT SYSTEM 80112 (AIS), AN OPTIONAL
ACCESSORY FOR THE
NUCLEUS 22 CHANNEL
COCHLEAR IMPLANT DEVICE
P840068/S026 VISTA 4, 6, AND T; GUIDANT CORP. REPLACEMENT OF THE
04/16/96 DELTA T AND TRS; ST. PAUL, MN CURRENT CONNECTOR
VISTA DDD; AND 55112-5798 TOP MATERIAL
VIGOR DDD
P850088/S033 OXYSEPT 1 ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 AND ULTRACARE IRVINE, CA STERILIZATION SITE
DISINFECTING 92713-9534 ISOTRON IRELAND LTD.,
SOLUTIONS AND OFFALY, IRELAND, AND USE
OXYSEPT 2 OF 100% ETHYLENE OXIDE
NEUTRALIZING TO STERILIZE PLASTIC
SOLUTION BOTTLES, TIPS, AND CAPS
P870007/S010 SORBIC ACID OPTOPICS LABORATORIES TRANSFER OF PROCESSING
04/22/96 PRESERVED STERILE CORP. SITE FOR 100% ETHYLENE
SALINE FOR SOFT FAIRTON, NJ OXIDE STERILIZATION
CONTACT LENSES 08320-0210 (GLEN FALLS, NY)
P870026/S006 RESOLVE/GP ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 DAILY CLEANER IRVINE, CA STERILIZATION SITE
92715-9534 ISOTRON IRELAND LTD.,
OFFALY, IRELAND AND USE
OF 100% ETHYLENE OXIDE
TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P870036/S036 VERSAFLEX MEDTRONICS REVISED LABELING
04/08/96 BUCHBINDER INTERVENTIONAL
OMNIFLEX PTCA SAN DIEGO, CA
CATHETER SYSTEM 92121-2256
MEDTRONIC 18K, 14K,
EVERGREEN, FALCON,
PANTHER, AND
PTCA CATHETERS
P870037/S007 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 PLUS WETTING AND IRVINE, CA STERILIZATION SITE
SOAKING SOLUTION 92715-9534 ISOTRON IRELAND LTD.,
OFFALY, IRELAND AND USE
OF 100% ETHYLENE OXIDE
TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P880003/S053 CORDIS CORDIS CORP. DEVICE MODIFICATION;
04/12/96 PERCUTANEOUS MIAMI, FL NEW TRADE NAME: CORDIS
TRANSLUMINAL 33102-5700 THOR PTCA CATHETER
CORONARY ANGIOPLASTY
(PTCA) DILATATION
CATHETERS
P880003/S055 CORDIS PTCA CORDIS CORP. DEVICE MODIFICATION;
04/23/96 DILATATION CATHETER MIAMI, FL NEW TRADE NAME: CORDIS
AND CORDIS VALOR 33102-5700 VALOR AND VALOR XL PTCA
AND VALOR XL PTCA CATHETERS
DILATATION CATHETERS
P880003/S056 CORDIS PTCA CORDIS CORP. ADDITIONAL BALLOON SIZES
04/23/96 DILATATION CATHETERS MIAMI, FL FOR THE THOR PTCA
AND CORDIS THOR PTCA 33102-5700 DILATATION CATHETERS
DILATATION CATHETERS (2.75MM,3.25MM, AND
AND 3.75MM DIAMETERS
AND 30MM LENGTHS)
P880031/S009 AMO VITRAX ALLERGAN MEDICAL NEW STERILIZATION SITE
04/09/96 VISCOELASTIC OPTICS (GRIFFITH MICRO SCIENCE,
SOLUTION IRVINE, CA GLEN FALLS, NY)
92713-9534 NEW STERILIZATION
PROCESS (100% ETHYLENE
OXIDE) FOR AMO VITRAX
(SODIUM HYALURONATE)
IN FINAL PACKAGING
P880031/S010 AMO VITRAX ALLERGAN MEDICAL USE OF
04/08/96 (SODIUM OPTICS "PHARMACEUTICAL
HYALURONATE) IRVINE, CA GRADE" SODIUM
92713-9534 HYALURONATE POWDER
FROM ALTERNATE SUPPLIER
P880072/S039 MODEL PA48A-OUV MEDICAL DEVELOPMENT MODELS PA48A-OUV VIA
04/08/96 ULTRAVIOLET- RESEARCH, INC. TIER A MODIFICATION
ABSORBING ST. PETERSBURG, FL
POSTERIOR CHAMBER 33716
INTRAOCULAR LENS
(IOL)
P880072/S040 MODELS GL65C-OUV MEDICAL DEVELOPMENT MODELS GL65C-OUV AND
04/17/96 AND PS50D-OUV RESEARCH, INC. PS50D-OUV VIA TIER A
ULTRAVIOLET- ST. PETERSBURG, FL MODIFICATION
ABSORBING 33716
POSTERIOR CHAMBER
INTRAOCULAR
LENSES (IOLS)
P880072/S042 POSTERIOR CHAMBER MEDICAL DEVELOPMENT APPROVAL FOR TIER A
04/24/96 INTRAOCULAR LENSES RESEARCH, INC. POSTERIOR CHAMBER
MODELS PA38E-OUV ST. PETERSBURG, FL INTRAOCULAR LENSES
AND PL52A-OUV 33716 MODELS PA38E-OUV
AND PL52A-OUV
P880098/S009 SF-P MENICON CO., LTD. LABELING CHANGES
04/03/96 (MELAFOCON A) WASHINGTON, D.C. ADDITION OF ALLERGAN,
RIGID GAS PERMEABLE 20005 INC.'S DESTAT 4 SYSTEM
CONTACT LENS FOR AND ALCON LABORATORIES,
EXTENDED WEAR INC.'S OPTI-SOAK SYSTEM
P890025/S009 TDX/TDXFLX ABBOTT LABORATORIES NEW PROBE CLEANING
04/01/96 CYCLOSPORINE ABBOTT PARK, IL PROCEDURE
MONOCLONAL 60064-3500
WHOLE BLOOD
P890027/S030 NUCLEUS 22 COCHLEAR CORP. MODIFICATIONS TO THE
04/04/96 CHANNEL COCHLEAR ENGLEWOOD, CO AUDIO INPUT SELECTOR
IMPLANT 80112 (AIS), AN OPTIONAL
ACCESSORY FOR THE
NUCLEUS 22 CHANNEL
COCHLEAR IMPLANT DEVICE
P900009/S002 SONIC ACCELERATED EXOGEN, INC. NEW MANUFACTURING
04/02/96 FRACTURE HEALING PISCATAWAY, NJ FACILITY WHICH IS
SYSTEM MODEL 2A 08855 OWNED AND OPERATED BY
HI-TRONICS DESIGNS,
INC., AND LOCATED AT
HACKETTSTOWN, NJ
P900047/S003 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 REWETTING DROPS IRVINE, CA STERILIZATION SITE
92713-9534 ISOTRON IRELAND LTD.,
OFFALY, IRELAND, AND USE
OF 100% ETHYLENE OXIDE
TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P900056/S015 ROTABLATOR HEART TECHNOLOGY, INC. ELIMINATION OF THE
04/23/96 ROTATIONAL REDMOND, WA USP MOUSE SAFETY TEST
ANGIOPLASTY SYSTEM 98052-3376 AS A STERILIZATION
LOAD RELEASE CRITERIA
P900061/S013 MODEL 7219 B/D/E MEDTRONIC, INC. APPROVAL FOR MODEL
04/15/96 JEWEL, MODEL 7202 MINNEAPOLIS, MN 7219 B/D/E JEWEL,
D/E JEWEL, MODEL 55432-3576 MODEL 7202 D/E/
7220 B/D/E JEWEL JEWEL, MODEL 7220
PLUS DEVICE USED B/D/E JEWEL PLUS
WITH CPI ENDOTAK DEVICE WITH ENDOTAK
SERIES LEADS SERIES LEADS
P910023/S016 CADENCE TIERED VENTRITEX, INC. APPROVAL TO STERILIZE
04/26/96 THERAPY SUNNYVALE, CA VENTRITEX PRODUCTS AT
DEFIBRILLATOR 94086-6527 SOREX MEDICAL, INC.,
SYSTEM USING CHAMBER 9
P910073/S016 ENDOTAK SQ LEAD GUIDANT CORP. ALTERNATIVE
04/04/96 ARRAY MODEL 0048 ST. PAUL, MN MANUFACTURING SITE:
AND ENDOTAK SQ 55112-5798 CARDIAC PACEMAKERS,
LEAD PATCH INC., DEL CARIBE,
MODEL 0063 ROAD 698 LOT NO. 12,
DORADO, PUERTO RICO
00646
P910073/S018 LEAD ADAPTER GUIDANT CORP. APPROVAL FOR LEAD
04/02/96 MODELS 6024, ST. PAUL, MN ADAPTER MODELS 6024,
6833, AND 6931 55112-5798 6833, 6931
P910073/S019 MODEL 6952 LEAD GUIDANT CORP. MODEL 6952 LEAD
04/01/96 EXTENDER ST. PAUL, MN EXTENDER
55112-5798
P910075/S005 COMPLETE BRAND ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 MULTI-PURPOSE IRVINE, CA STERILIZATION SITE
SOLUTION AND 92713-9534 ISOTRON IRELAND LTD.,
COMPLETE BRAND OFFALY, IRELAND, AND USE
LUBRICATING AND OF 100% ETHYLENE OXIDE
REWETTING DROPS TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P920014/S003 TCI HEARTMATE THERMO CARDIOSYSTEMS, CHANGE IN THE DESIGN
04/12/96 IP LVAS INC. OF THE NON-BLOOD
WOBURN, MA CONTACTING TITANIUM
01888-2697 COMPONENTS USED IN
THE INFLOW AND
OUTFLOW VALVE CONDUITS
AND IN THE OUTFLOW
GRAFT CONDUIT
P920015/S009 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR THE
04/08/96 MODEL 6707 MINNEAPOLIS, MN MODEL 6707 ADAPTER
ADAPTER 55432-3576
P920032/S002 MICRO-PACE PACE MEDICAL, INC. APPROVAL FOR THE
04/26/96 MODEL 4553 WALTHAM, MA PACESETTER, INC.,
DUAL DDD 02154 MODEL 3070B PRIVATE
CHAMBER TEMPORARY LABEL VERSION OF THE
CARDIAC PACEMAKER PACE MEDICAL MODEL 4575
P930012/S001 PROGRESSIVE PROGRESSIVE USE OF 100% ETHYLENE
04/02/96 ANGIOPLASTY ANGIOPLASTY SYSTEMS OXIDE STERILIZATION
SYSTEMS (PAS) MENLO PARK, CA TO BE PERFORMED AT
LACROSSE PTCA 94025 MEDICAL MANUFACTURING
CORONARY CORP., ERIE, PA
DILATATION CATHETER
P930012/S002 PROGRESSIVE PROGRESSIVE ADDITION OF 1.5MM
04/16/96 ANGIOPLASTY ANGIOPLASTY SYSTEMS DIAMETER, 20 MM
SYSTEMS (PAS) MENLO PARK, CA LENGTH BALLOON;
LACROSSE PTCA 94025-1516 ADDITION OF 2.5MM,
CORONARY 3.0MM, AND 4.0MM
DILATATION CATHETER BALLOONS
P940034/S001 GENPROBE GEN-PROBE INC. COMPONENT, SHELF
04/23/96 AMPLIFIED SAN DIEGO, CA LIFE, AND LABELING
MYCOBACTERIUM 92121 CHANGES; NEW VENDOR
TUBERCULOSIS OF REVERSE
DIRECT (MTD) TEST TRANSCRIPTASE
P950009/S001 AUTOPAP 300 QC NEOPATH, INC. CHANGE IN MANUAL TO
04/25/96 SYSTEM REDMOND, WA IMPROVE HOW THE REPORT
98052 FORMS WILL LOOK, FOR
CLARITY
***ORIGINAL VETERINARY NADAs***
141-043 SYNOVEX PLUS CATTLE SYNTEX AN HLTH ESTRADIOL BENZOATE
22-FEB-96 (EAR IMPLANT) PALO ALTO, CA 2.5MG
94304 TRENBOLONE ACETATE
25MG
***ORIGINAL ABBREVIATED VETERINARY NADAs***
200-170 NICARMIX 25 BROILER PLANALQUIMICA IND LTDA LINCOMYCIN
02-APR-96 3-NITRO CHICKENS SAO PAULO, BRAZIL HYDROCHLORIDE
LINCOMIX 4,20,50GM/LB
(TYPE A MEDICATED NICARBAZIN
ARTICLES) 113.5GM/LB
ROXARSONE
10,20,50,80%
200-171 NICARMIX 25 BROILER PLANALQUIMICA IND LTDA LINCOMYCIN
02-APR-96 LINCOMIX CHICKENS SAO PAULO, BRAZIL HYDROCHLORIDE
(TYPE A MEDICATED 4,20,50GM/LB
ARTICLES) NICARBAZIN
113.5GM/LB
200-172 NICARMIX 25 BROILER PLANALQUIMICA IND LTDA NICARBAZIN
02-APR-96 3-NITRO CHICKENS SAO PAULO, BRAZIL 113.5GM/LB
(TYPE A MEDICATED ROXARSONE
ARTICLES) 10,20,50,80%
***SUPPLEMENTAL VETERINARY NADAs***
140-971 HEARTGARD-300 PLUS DOGS MERCK IVERMECTIN
15-FEB-96 (TABLET) RAHWAY, NJ 68MCG
07065 PYRANTEL PAMOATE
57MG
Date created: July 11, 1996; last updated: June 20, 2005 |
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