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1996 and Older - New Drug Application (NDA)
New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
20195/S-002 5/20/96 8/2/99 Fragmin/dalteparin sodium Injection [1.5 MB] Pharmacia and Upjohn 020287/S005 9/24/1996 2/4/1998 Heptolite, Kit for the Preparation of Technetium Tc 99m Disofenin Merck 18467/ S-13 & S-14 12/29/1993 8/5...
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http://www.fda.gov/cder/orange/appendix_a.txt
3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
15258 23-Jan-01 ISOCHEM SA "EPAL-NCA AS MFG IN VERT-LE-PETIT, FRANCE" 15259 22-Jan-01 SANOFI CHIMIE "FONDAPARINUX SODIUM AS MFG IN SISTERON (CEDEX) AND NOTRE DAME DE BONDEVILLE, FRANCE" 15261 24-Jan-01 TEVA GROUP "AZITHROMYCIN AS MANUFACTURED IN BE'ER SHEVA AND PETACH TIQVA, ISRAEL" 15262 05-Feb-01 DIOSYNTH BV "RECOMBINANT HUMAN INSULIN AS MFG IN THE NETHERLANDS, FRANCE, AND ISRAEL."...
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http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
URSODEOXYCHOLIC ACID MEDIMPEX INC ALPHA METHYLDOPA USP XIX BULK AS MFG BY EGIS PHARMACEUT WORKS BUDAPEST ACRAF TRAZODONE HCL ROCHE COLORADO CORPORATION BUTOCONAZOLE NITRATE GEDEON RICHTER LTD NORETHISTERONE DINAMITE DIPHARMA SPA FUROSEMIDE USP SCHERING AG ESTRADIOL-VALERATE SCHERING AG TESTOSTERONE ENANTHATE PROQUINA SA PIPERAZINE ESTRONE SULFATE MERCK AG METHYL GLUCAMINE (PRODUCT ...
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Prescription and Over-the-Counter Drug Product List: 10/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 500MG/15ML;7.5MG/15ML N40520 001 OCT 30, 2003 OCT NEWA TABLET; ORAL ANEXSIA >D> AA MALLINCKRODT 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA >A> AA 750MG;10MG N40468 001 OCT 31, 2002 OCT CTNA ALBUTEROL SULFATE TABLET...
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ANDA Approvals - October 2003
- FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - October 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-416 WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5 MG, 3 MG 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG - UPSHER-SMITH LABORATORIES, INC
10/7/2003- 5 40-512 PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MG - BARR...
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Prescription and Over-the-Counter Drug Product List: 5/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
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ANDA Approvals January 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - January 2003 - ANDA Number- Generic Drug Name Applicant Approval Date 1 40-474 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MG ABLE LABORATORIES, INC
1/6/03 3 76-266 DOXAPRAM HYDROCHLORIDE INJECTION, USP 20 MG/ML (400 MG/20 ML) MULTIPLE- DOSE...
author: OGD
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Prescription and Over-the-Counter Drug Product List: 1/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE -A- SOLUTION; ORAL -A- ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE -A- + MIKART 325MG/15ML;50MG/15ML;40MG/15ML N40387 001 JAN 31, 2003 JAN NEWA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPAHTE -A- AA ANDRX PHARMS 300MG;15MG N40443 001 JAN 22, 2003 JAN NEWA -A- AA...
author: AUTHOR
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ANDA Approvals March 2003
Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-455 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
3/5/2003- 4 40-497 PHENTERMINE HYDROCHLORIDE...
author: OGD
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Prescription and Over-the-Counter Drug Product List: 3/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
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1997 Abbreviated New Drug Applications (Generic Drugs)
074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/Actuation
64136 9/30/96 4/13/99 Clomipramine Hydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
74-648 3/18/97 4/8...
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FDA Drug Approvals List August 2001
Active Ingredient(s): PROPRANOLOL HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 040427 Tentative Approval Date: 30-AUG-01 Trade Name: PHENTERMINE HYDROCHLORIDE Dosage Form: CAPSULE Applicant:ABLE LABORATORIES, INC
Active Ingredient(s): PHENTERMINE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application #: 040402...
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FDA Drug Approvals List January 2002
- Drug Approvals for January 2002 Definitions and Notes Original New Drug Applications Efficacy Supplemental New Drug Applications Application #: 020837 Efficacy Supplement #: 006 Type: SE5 to Original New Drug Application Approval Date: 30-JAN-02 Trade Name: XOPENEX Dosage Form: SOLUTION Applicant: SEPRACOR, INC Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE OTC/RX Status:...
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Prescription and OTC Drug Product List 8/2001
ACTHAR GEL -D- BC + AVENTIS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -D- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN -A- BC + QUESTCOR PHARMS 40 UNITS/ML N08372 006 FEB 06, 1956 AUG CAHN -A- BC + 80 UNITS/ML N08372 008 FEB 06, 1956 AUG CAHN DELAVIRDINE MESYLATE TABLET; ORAL RESCRIPTOR -D- + AGOURON 100MG N20705 001 APR 04, 1997 AUG CRLD -A- 100MG N20705 001 APR 04, 1997 AUG...
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Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA + WATSON LABS 325MG;7.5MG...
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Prescription and OTC Drug Product List 1/2002
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
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Microsoft Word - 40402ltr.doc
ANDA 40- 402 August 30, 2001 Able Laboratories Inc
Attention: Shashikant Shah 6 Hollywood Court South Plainfield, NJ 07080- 4295 Dear Sir: This is in reference to your abbreviated new drug application dated February 10, 2000, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Phentermine Hydrochloride Tablets USP, 37.5 mg
author: staufferp
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Microsoft Word - 40402ltr.doc page 1
author: staufferp
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Microsoft Word - 40403ltr.doc
ANDA 40- 403 August 30, 2001 Able Laboratories Inc
6 Hollywood Court South Plainfield, NJ 07080- 4295 Dear Sir: This is in reference to your abbreviated new drug application dated February 14, 2000, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Phentermine Hydrochloride Capsules USP, 30 mg
We have completed the review...
author: staufferp
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Microsoft Word - 40403ltr.doc page 1
author: staufferp
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ANDA 40-377 page 1
author: CDER USER
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SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric
Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
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Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 37
author: FDA
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Annual Comprehensive List of Guidance Documents at the Food and Drug Administration page 33
author: FDA
subject: 7/21/2000
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