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Drug Approvals - D
NDA 21-333 9/16/02 9/20/02 9/17/02 - Desogestrel & Ethinyl Estradiol Tablets, Rx Barr Laboratories ANDA 76-455 2/24/04 4/15/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively, Rx Tentatively Approved Duramed Pharmaceuticals ANDA 75-863 11/29/01 4/15/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively Duramed Pharmaceuticals ANDA 75-256/S7 06...
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TEXT
http://www.fda.gov/cder/orange/appendix_a.txt
45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...

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TEXT
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...

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DOC
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...

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ANDA Approvals: March, 2002
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-385 BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG ZENITH GOLDLINE PHARMACEUTICALS, INC
3/1/02 2 75-610 FAMOTIDINE TABLETS, USP (OTC) 10 MG TORPHARM 3/12/02 3 75-824 BUTORPHANOL TARTRATE NASAL...
author: AmesT
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Alefacept (Amevive) Clinical Review page 64


author: CBER FDA subject: dob062703
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Galderma
September 25, 2003-- - Acne Rosacea Skin Care Topical Steroids Hair & Scalp Desowen ® Product Insert Information DESOWEN® (desonide cream, ointment and lotion) cream 0.05%, ointment 0.05%, and lotion 0.05% FOR DERMATOLOGIC USE ONLY NOT FOR OPTHALMIC USE DESCRIPTION: DESOWEN ® Cream 0.05%, Ointment 0.05%, and Lotion 0.05% contain desonide (Pregna-1,4-diene-3, 20-dione,11...
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FDA Drug Approvals List March 2001
Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever,...
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FDA Drug Approvals List March 2002
- Drug Approvals for March 2002 Definitions and Notes Original New Drug Applications Original Application #: 020855 Approval Date: 21-MAR-02 Trade Name: MESNA Chemical Type: 3 Therapeutic Potential: S Dosage Form: TABLET Applicant: ASTA MEDICA AG Active Ingredient(s): MESNA OTC/RX Status: RX Indication(s): For the use as a prophylactic agent in reducing the incidence of ifosfamide...
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Prescription and OTC Drug Product List 3/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE AEROSOL, METERED; INHALATION PROVENTIL-HFA -D- + 3M EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20503 001 AUG 15, 1996 MAR CTEC VENTOLIN HFA -D- + GLAXOSMITHKLINE EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC -A- BX + EQ 0.09MG BASE/INH N20983 001 APR 19, 2001 MAR CTEC...
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Farmacie Petrone Pharmaceuticals Supply
HYALECTIN), ACIDO IOPANOICO, ACIDO IOTALAMICO (SALE DI MEGLUMINA), ACIDO IOTALAMICO (SALE SODICO), ACIDO IOXAGLICO (SALE SODICO, ACIDO LATTICO, ACIDO LINOLEICO, ACIDO MA, ACIDO MALICO, ACIDO MECLOFENAMICO, ACIDO MECLOFENAMICO (SALE SODICO), ACIDO MEFENAMICO, ACIDO NALIDIXICO, ACIDO NIFLUMICO, ACIDO OROTICO, ACIDO PALMITICO, ACIDO PAMIDRONICO (SALE DISODICO), ACIDO PIPEMIDICO, ACIDO...
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Medicines, Ethics and Practice page 8


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http://www.fda.gov/cder/foi/appletter/2001/75751ltr.pdf
ANDA 75- 751 March 12, 2001 Altana Inc
Attention: Virginia Carman 60 Baylis Road Melville, NY 11747 Dear Madam: This is in reference to your abbreviated new drug application dated December 7, 1999, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Desonide Ointment, 0.05%
Accordingly the application is approved
The Division of...

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http://www.fda.gov/cder/foi/appletter/2001/75751ltr.pdf page 1


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Prescription and OTC Drug Product List 9/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 9: September 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE ATENOLOL CAPSULE; ORAL TABLET; ORAL - DLT - BUTALBITAL, ACETAMINOPHEN, CAFFEINE ATENOLOL - DLT - AB GRAHAM DM 325MG;50MG;40MG N88758 001 - ADD - MYLAN 25MG...
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Prescription and OTC Drug Product List 3/2001
Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 3: January-March 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE ATORVASTATIN CALCIUM CAPSULE; ORAL TABLET; ORAL - ADD - BUTALBITAL; ACETAMINOPHEN; AND CAFFEINE WITH CODEINE LIPITOR - ADD - PHOSPHATE ...
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FARMACIE PETRONE S.r.l. - NAPOLI ITALY
HYALECTIN), ACIDO IOPANOICO, ACIDO IOTALAMICO (SALE DI MEGLUMINA), ACIDO IOTALAMICO (SALE SODICO), ACIDO IOXAGLICO (SALE SODICO, ACIDO LATTICO, ACIDO LINOLEICO, ACIDO MA, ACIDO MALICO, ACIDO MECLOFENAMICO, ACIDO MECLOFENAMICO (SALE SODICO), ACIDO MEFENAMICO, ACIDO NALIDIXICO, ACIDO NIFLUMICO, ACIDO OROTICO, ACIDO PALMITICO, ACIDO PAMIDRONICO (SALE DISODICO), ACIDO PIPEMIDICO, ACIDO...
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DDPA June 1995
74-423 CAPTOPRIL MOVA CAPTOPRIL 07-JUN-95 (TABLET) CAGUAS, PR 12.5MG 00725 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-911 CLINORIL MERCK SULINDAC 01-JUN-95 (TABLET) WEST POINT, PA 150MG 19486 200MG (LABELING REVISION -- PRECAUTIONS; ADVERSE REACTIONS) 16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE 02-JUN-95 (TABLET) PALO...
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DDPA 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)...
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WORDPERFECT
http://www.fda.gov/cder/da/ddpa92.wpd
20 005 CARDENE SR SYNTEX NICARDIPINE HYDROCHLORIDE 01 23 92 (CAPSULE, PALO ALTO, CA 30MG EXTENDED RELEASE) 94304 45MG 60MG (CALCIUM ION INFLUX INHIBITOR) [HYPERTENSION] 73 243* LOPERAMIDE HCL PERRIGO LOPERAMIDE HYDROCHLORIDE 01 21 92 (SOLUTION) ALLEGAN, MI 1MG/5ML 49010 (ANTIDIARRHEAL) (OTC) 81 264 BENZTROPINE MESYLATE MUTUAL PHARM BENZTROPINE MESYLATE 01 23 92 (TABLET) PHILADELPHIA,...

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