http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
HYDROCODONE ACETAMIN! page 1
author: Jamie Dorgan
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...
Prescription and Over-the-Counter Drug Product List: 12/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001 SEP 10,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt INC-MAYAQUEZ, P.R." 4884 15-Mar-83 MALLINCKRODT CHEMICAL INC "HYDROCODONE BITARTRATE -MFGR STHYDROCODONE BITARTRATE AS MFGHYDROCODONE ...
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 ...
ANDA Approvals - December 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - December 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-161 AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE) 200 MG/28.5 MG (BASE) AND 400 MG/57 MG (BASE) - RANBAXY LABORATORIES LIMITED 12/3/2003- 2 76-656 FENOLDOPAM MESYLATE INJECTION, USP 10 MG...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - TABLET; ORAL Approved 2/28/2003- BACLOFEN 10 mg, 20 mg - 02P-0078/CP1 KLEINFELD, KAPLAN & BECKER - ORALLY DISINTEGRATING TABLETS Approved 2/5/2003- OXYCODONE 5mg, 7.5mg, 10mg ACETAMINOPHEN 300mg - 02P-0105/CP1 LACHMAN CONSULTANT SERVICES - TABLETS Approved 8/6/2002- CARISOPRODOL 350 mg - 02P-0138/CP1 LACHMAN CONSULTANT SERVICES - ORALLY DISINTEGRATING TABLETS Withdrawn 7/25...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - TABLET; ORAL Withdrawn 1/2/2002- HYDROCODONE BITARTRATE 10 MG/15 ML ACETAMINOPHEN 300 MG/15 ML - 01P-0524/CP1 LACHMAN CONSULTANT SERVICES - SOLUTION; ORAL Approved 8/6/2002- HYDROCODONE BITARTRATE 5 mg ACETAMINOPHEN 500 mg - 02P-0233/CP1 KLEINFELD, KAPLAN AND BECKER - ORALLY DISINTEGRATING TABLETS Approved 2/5/2003- HYDROCODONE ...
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,...
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, INCHYDROCODONE BITARTRATE AND ...
ANDA Approvals - September 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - September 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-220 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - RANBAXY LABORATORIES LIMITED 9/2/2003- 2 76-093 OFLOXACIN TABLETS 200 MG, 300 MG, AND 400 MG - PAR PHARMACEUTICAL, INC
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...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML...
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, INCHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/500 MG ABLE...
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 ...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 4/2003 45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10, 2003 APR...
author: AUTHOR
ANDA Approvals - August 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - August 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-080 AMOXICILLIN TABLETS FOR ORAL SUSPENSION 200 MG AND 400 MG - RANBAXY LABORATORIES LIMITED 8/11/2003- 2 76-134 LORATADINE TABLETS (OTC) 10 MG - RANBAXY LABORATORIES LIMITED 8/18/2003- 3 76-453 LIDOCAINE...
ANDAs Approvals - May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals May 2000 - 1
author: USERNAME
ANDAs Approvals - July 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals - July 2000 1
author: USERNAME
ANDAs Approvals - September 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals- September 2000 Page: 1 Friday, October 06, 2000 1HYDROCODONE BITARTRATE MALLINCKRODT, INCACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG 2
author: USERNAME
ANDAs Approvals - October 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals - October 2000 Page: 1 1ACETAMINOPHEN CAPSULES, USP 5 MG/500 MG 2
author: USERNAME
ANDA Drug Approvals - October 2002 10/21/02 13 40-464 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG, AND 10 MG/325 MG ABLE LABORATORIES, INCHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/650 MG ABLE LABORATORIES, INC
author: OGD
ANDA Drug Approvals - November 2002 -U.SHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/500 MG ABLE LABORATORIES, INCHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/500 MG ABLE LABORATORIES, INC
author: OGD
