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,...
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf Barr Laboratories, Inc.
http://www.barrlabs.com/overview/annual/BRL_AR2001.pdf page 23
http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf Research and devel pment resulted in a rec rd number f new pr duct appr vals that expanded ur fferings in key therapeutic categ ries.
http://www.barrlabs.com/overview/annual/BRL_AR2002.pdf page 16
Drug Approvals - D ANDA 40-480 9/9/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx Abrika Pharmaceuticals ANDA 40-472 9/30/03 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx Watson Laboratories ANDA 40-456 5/6/03 - - -...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol ...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LISINOPRIL CRUDE AS MFG IN COURBEVOIE AND HAM FRANCE 14537 19-Nov-99 FUJISAWA PHARMACEUTICAL CO LTD FK8453 DRUG SUBSTANCE AS MFG IN HYOGO AND OSAKA JAPAN 14538 09-Nov-99 SICOR DE MEXICO SA DE CV AMCINONIDE AS MFG IN LERMA MEXICO 14539 18-Nov-99 "UQUIFA ITALIA, S.P.A." CLINDAMYCIN HYDROCHLORIDE USP AS MFG IN MILAN ITALY 14540 18-Nov-99 DIOSYNTH BV TESTOSTERONE UNDECANOATE AS MFG IN...
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 ...
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, INCDEXTROAMPHETAMINE TABLETS ...
Prescription and Over-the-Counter Drug Product List: 9/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG;10MG...
author: AUTHOR
ANDA Approvals May 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - May 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 75-681 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/ML COPLEY PHARMACEUTICAL, INCDEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 5 MG, 10 MG, AND 15 MG MALLINCKRODT INC...
author: OGD
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
Prescription and Over-the-Counter Drug Product List: 7/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL PROPOXYPHENE HCL AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 650MG;65MG N40507 001 JUL 30, 2003 JUL NEWA ACYCLOVIR TABLET; ORAL ACYCLOVIR >D> AB CLONMEL HLTHCARE 400MG N74834 001 APR 24, 1997 JUL DISC >A> @ 400MG N74834 001 APR 24, 1997 JUL DISC >D> AB 800MG N74834 002 APR 24,...
author: AUTHOR
ANDA Approvals February 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - February 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-810 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) BARR LABORATORIES, INC
author: USERNAME
ANDA Drug Approvals - October 2002 -U.S
author: OGD
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
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
FDA Drug Approvals List October 2001 - Drug Approvals for October 2001 Definitions and Notes Original New Drug Applications Original Application #: 021356 Approval Date: 26-OCT-01 Trade Name: VIREAD Chemical Type: 1 Therapeutic Potential: P Dosage Form: TABLET Applicant: GILEAD SCIENCES INC Active Ingredient(s): TENOFOVIR DISOPROXIL FUMARATE OTC/RX Status: RX Indication(s): For use in combination with other...
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: RX...
Prescription and OTC Drug Product List 10/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE -D- AA MIKART 356.4MG;30MG;16MG N40109 001 AUG 26, 1997 OCT CRLD -A- + 356.4MG;30MG;16MG N40109 001 AUG 26, 1997 OCT CRLD DHC PLUS -D- AA + PURDUE FREDERICK 356.4MG;30MG;16MG N88584 001 MAR 04, 1986 OCT DISC -A-...
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
Prescription and OTC Drug Product List 9/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG...
Prescription and OTC Drug Product List 8/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001 AUG...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN -D- @...
