http://www.fda.gov/cder/orange/appendix_a.txt PEDIATRIC, ASCORBIC ACID M.V.I.-12 LYOPHILIZED, ASCORBIC ACID M.V.I.-12, ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACROTEC, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT MAGNACORT, HYDROCORTAMATE HYDROCHLORIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE...
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 OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 11274 27-Dec-94 FUJI CHEMICAL INDUSTRIES LTD "DINOPROSTONE (PROSTAGLANDIN E2) MANUFACTURED IN TOYAMA, JAPAN." 11276 29-Dec-94 TAKASAGO INTERNATIONAL CORP "A-87172.0 MANUFACTURED IN SHIZUOKA PREFECTURE, JAPAN." 11280 04-Jan-95 PLIVA "MESALAZINE N MANUFACTURED IN SAVSKI MAROF, CROATIA" 11282 05-Jan-95 KANEKA CORP "KPM-1648 MANUFACTURED IN HYOGO, JAPAN" 11287 29-Dec-94 DOW CHEMICAL CO ...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATIONPROMETHAZINE HCL...
Prescription and Over-the-Counter Drug Product List: 6/2003 >D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN >D> AB WYETH...
author: AUTHOR
ANDAs Approvals - June 2000 40-372 PROMETHAZINE ABBOTT LABORATORIES 6/8/00 HYDROCHLORIDE INJECTION, USP 25 MG/ML (SYRINGE) 50 MG/ML (SYRINGE) 3MEPERIDINE HYDROCHLORIDE MALLINCKRODT INCHYDROCHLORIDE INJECTION 1 MG (BASE)/ML (VIALS) 5 MG (BASE)/ML (VIALS) 8HYDROCHLORIDE INJECTION 1 MG (BASE)/ML (VIALS) 5 MG...
author: USERNAME
ANDA Approvals - August 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - August 2002 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-452 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/30 MG ABLE LABORATORIES, INCHYDROCHLORIDE AND ACETAMINOPHEN TABLETS 25 MG (BASE)/650 MG AMIDE...
author: OGD
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/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
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...
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 6/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 6: June 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETOHEXAMIDE BLEOMYCIN SULFATE TABLET; ORAL INJECTABLE; INJECTION ACETOHEXAMIDE BLEOMYCIN - DLT - AB BARR 500MG N70870 001 - ADD - AP GENSIA SICOR PHARMS EQ 15 UNITS BASE/VIAL N65033 001 - DLT - FEB...
PDPL - ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/50-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON...
FDA Drug Approvals List June 2000 Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application # 075448 Approval Date: 19-JUN-00 Trade Name: ISOSORBIDE MONONITRATE Dosage Form: TABLET, EXTENDED RELEASE Applicant: ZENITH GOLDLINE PHARMACEUTICALS Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX Original Abbreviated Application # 075549 Approval Date: 13-JUN-00...
RLD_LABELING_ APPROVED_AUG_1999 19-452 S-015 Hill Derm 18-Aug-1999 EULEXIN Flutamide Capsules 18-554 S-015 Schering 19-Aug-1999 MEPERGAN Meperidine HCl/Promethazine HCl 11-730 S-023 Wyeth Ayerst Labs 19-Aug-1999 ALDOCLOR-250 Methyldopa/Chlorthiazide Tablets 16-016 S-070 Merck 22-Aug-1999 INDERAL Propranolol HCl Tablets 16-418 S-071 Wyeth Ayerst Labs 22-Aug-1999 INDERAL Propranolol HCl Injection 16-419 S...
