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,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt INC-MAYAQUEZ, P.R." 4884 15-Mar-83 MALLINCKRODT CHEMICAL INC "HYDROCODONE BITARTRATE -MFGR STHOMATROPINE METHYLBROMIDE AT INGELHEIM AM RHEIN PLANT 5477 24-Jul-84 AAIPHARMA LLC "PROPOXYPHENE NAPSYLATE PRODUCED BY TIPPECANOE LABS IN LAFAYETTE, IN." 5478 19-Jul-84 DINAMITE DIPHARMA SPA NAPROXEN SODIUM AS MFG IN THE MILANO FACILITIES 5487 13-Jun-84 UPJOHN CO ...
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 ...
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-...
author: AUTHOR
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 +...
Hycodan 6479-03 Tabs/Syr page 1
author: John J. Carmody
Prescription and OTC Drug Product List 12/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 12: December 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - ADD - BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE TABLET; ORAL - ADD - GEL; TOPICAL OXYCODONE AND ACETAMINOPHEN - ADD - BENZACLIN - ADD - AA WATSON LABS...
ANDA Approvals December 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals December 2000 - ANDA Number-- DRUG NAME APPLICANT Approval DATE 1 - 40-295 HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE TABLETS 5 MG/1.5 MG AMIDE PHARMACEUTICAL, INC
author: USERNAME
FDA Drug Approvals List December 2000 - Drug Approvals for December 2000 Definitions and Notes Original New Drug Applications Original Application #: 021228 Approval Date: 22-DEC-00 Trade Name: DETROL LA Chemical Type: 3 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: PHARMACIA AND UPJOHN CO Active Ingredient(s): TOLTERODINE TARTRATE OTC/RX Status: RX Indication(s): For the treatment of overactive bladder with...
ANDA 40-295 ANDA 40- 295 December 1, 2000 Amide Pharmaceutical, IncHydrocodone Bitartrate and Homatropine ...
author: CDER User
ANDA 40-295 page 1
author: CDER User
FDA Drug Approvals List July 1999 Drug Approvals for July 1999 Definitions and Notes Original New Drug Applications Original Application #: 021057 Approval Date: 29-JUL-99 Trade Name: ANTAGON Chemical Type: 1 Therapeutic Potential: P Dosage Form: INJECTABLE Applicant: ORGANON INC Active Ingredient(s): GANIRELIX ACETATE OTC/RX Status: RX Indication(s): Provides for the inhibition of premature LH surges in women...
40285.AP.DOC ANDA 40- 285 July 19, 1999 Halsey Drug Company, IncHydrocodone Bitartrate and Homatropine Methylbromide Syrup, 5 mg and 1.5 mg,...
author: Unknown
40285.AP.DOC page 1
author: Unknown
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
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP 04,...
