http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 11863 14-Feb-96 BROOKHAVEN NATIONAL LAB "CU-67 BULK RADIOISOTOPIC PRODUCT MANUFACTURED IN UPTON, NEW YORK." 11866 27-Feb-96 ESTEVE QUIMICA SA "ENALAPRIL MALEATE MANUFACTURED IN BARCELONA, SPAIN." 11876 28-Feb-96 GIULINI CHEMIE GMBH "SUCRALFATE POWDER MANUFACTURED IN LUDWIGSHAFEN/RHEIN, GERMANY." 11877 04-Mar-96 CILAG AG "ARTICAINE HYDROCHLORIDE MANUFACTURED IN...
NMEs Approved in CY 2000 NMEs Approved in Calendar Year 2000 NDA Number Generic Name- Trade Name Dosage Form Applicant - --- Classification- Approval Date 20-989 Cevimeline HCl Evoxac Capsule Snowbrand 1S 01-11-2000 21-014 Oxcarbazepine Trileptal Tablet Novartis Pharms 1S 01-14-2000 20-987 Pantoprazole Sodium Protonix Tablet Wyeth Ayerst 1S 02-02-2000 21-107 Alosetron HC1 Lotronex Tablet Glaxo Wellcome 1P 02...
author: Susan Daugherty
20-971_Septocaine Food and Drug Administration • Center for Drug Evaluation and Research Title Search Septocaine (Articaine Hydrochloride w/Epinephrine) Injection- Company:--Deproco, Inc
author: USERNAME
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: 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...
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...
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
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7...
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...
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...
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
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Bulk, Group C Meningococcal Polysaccharide Vaccine Group A Meningococcal Polysaccharide Vaccine Group C Meningococcal Polysaccharide Vaccine Group A and C Menotropin Meperidine HCl Injection Mephentermine Sulfate Mepivacaine HCl Mepivacaine HCl and Levonordefrin Meprobamate Injection Meprylcaine HCI and Epinephrine Mercaptomerin Sodium Mersalyl with theophylline Merethoxylline...
author: FDA / CBER
subject: December 1987 Guideline
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...
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
Prescription and OTC Drug Product List 11/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 11: November 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CLOBETASOL PROPIONATE TABLET; ORAL OINTMENT; TOPICAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN EMBELINE - ADD - ENDO PHARMS 400MG;5MG N40288 001 ...
