http://www.fda.gov/cder/orange/appendix_a.txt 1/35 28, ETHINYL ESTRADIOL NABUMETONE, NABUMETONE NADOLOL, NADOLOL NAFAZAIR, NAPHAZOLINE HYDROCHLORIDE NAFCILLIN SODIUM, NAFCILLIN SODIUM NAFTIN, NAFTIFINE HYDROCHLORIDE NALBUPHINE HCL, NALBUPHINE HYDROCHLORIDE NALBUPHINE, NALBUPHINE HYDROCHLORIDE NALFON 200, FENOPROFEN CALCIUM NALFON, FENOPROFEN CALCIUM NALIDIXIC ACID, NALIDIXIC ACID APPENDIX A PRODUCT NAME INDEX NALLPEN IN PLASTIC...
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...
First-Time Generics - February 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - February 2003 - Generic Drug Name Generic Manufacturer Brand Name- Approval Date 1 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG/ML AND 50 MG/5 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INCNAVELBINE INJECTION 2/3...
author: OGD
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
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 Trade...
FDA Drug Approvals List May 2000 Dosage Form: INJECTABLE Applicant: ASTRAZENECA UK LTD Active Ingredient(s): MEROPENEM OTC/RX Status: RX Application #: 020073 Labeling Supplement#: 010 To Original New Drug Application Approval Date: 22-MAY-00 Trade Name: ROMAZICON Dosage Form: INJECTABLE Applicant: HLR TECHNOLOGY Active Ingredient(s): FLUMAZENIL OTC/RX Status: RX Application #: 020760 Labeling Supplement#: 006 To...
FDA Drug Approvals List- January 1998 Dosage Form: INJECTABLE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): GONADOTROPIN, CHORIONIC OTC/RX Status: RX Application #: 020729 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 21-JAN-98 Trade Name: UNIRETIC Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX Status...
FDA Drug Approvals List November 2000 Active Ingredient(s): VINORELBINE TARTRATE OTC/RX Status: RX Application #: 018936 Labeling Supplement #: 063 To Original New Drug Application Approval Date: 28-NOV-00 Trade Name: PROZAC Dosage Form: CAPSULE Applicant: LILLY RESEARCH LABORATORIES DIV ELI LILLY AND CO Active Ingredient(s): FLUOXETINE HYDROCHLORIDE OTC/RX Status: RX Application #: 018936 Labeling Supplement...
DDPA May 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 50-521 CECLOR ELI LILLY CEFACLOR 01-MAY-96 (CAPSULE) INDIANAPOLIS, IN EQ 250MG BASE 46285 EQ 500MG BASE (LABELING REVISION -- CLINICAL PHARMACOLOGY; ADVERSE REACTIONS) 50-522 CECLOR ELI LILLY CEFACLOR 01-MAY-96 (POWDER INDIANAPOLIS, IN EQ 125MG BASE/5ML FOR RECONSTITUTION) 46285 EQ 187MG BASE/5ML EQ 250MG BASE/5ML EQ 375MG BASE/5ML ...
DDPA February 1996 THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS FOR FEBRUARY 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-123 OMNIS CAN NYCOMED GADODIAMIDE 05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML 19087 (LABELING REVISION -- INDICATIONS AND USAGE; DOSAGE AND ADMINISTRATION) 19-099 DOPAMINE HCL AND MCGAW DOPAMINE HYDROCHLORIDE 07-FEB-96 DEXTROSE 5% IRVINE, CA...
Drug Approvals for August 1997 Drug Approvals for August 1997 Definitions and Notes August 1997 Original New Drug Applications Original Application #: 020808 Approval Date: 29-AUG-97 Trade Name: VISIPAQUE Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): IODIXANOL OTC/RX Status: RX Indication(s): Intra-arterial - for visceral intra-arterial digital...
Forum - Read Topic Ktze 95% HPLC Polyphenols Oyster Extract Oyster 10% HPLC Taurine Paeonia suffruticosa Extract Paeonia suffruticosa 99% UV-VIS Paeonol Papaya Extract papaw Carica papaya 60,000U/G a-acetolactate Sub-enzyme Papain Passion flower Extract Passiflora incarnata L 5% HPLC flavonoid Peony Root Extract Paeonia officinalis L 8% HPLC Paeoniflorin Peppermint Extract Mentha piperita 95% HPLC...
Cedra Corp. Methods List April 2004.xls Humor 0.025 mL 1 250 ng/ mL Tizanidine Human Heparin Plasma 0.5 mL 0.1 – 50 ng/ mL Tolterodine Human Heparin Plasma 0.5 mL 0.5 – 50 ng/ mL Tramadol* and 5- 200 ng/ mL M1* 1- 40 ng/ mL Tramadol* and 1 250 ng/ mL M1* 0.5 125 ng/ mL 10- 400 ng/ mL 10- 400 ng/ mL Tramadol* and 10 – 1000 ng/ mL O- Desmethyltramadol* 10 – 1000 ng/ mL N- Desmethyltramadol* 10 – 1000...
author: Information Systems
Cedra Corp. Methods List April 2004.xls page 11
author: Information Systems
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, 2003 DEC CTNA...
Cedra Corp. Methods List January 2004.xls page 10
author: Information Systems
Cedra Corp. Methods List January 2004.xls Humor LC- MS- MS 0.1 250 ng/ mL Tizanidine Human Heparin Plasma LC- MS- MS 0.1 – 50 ng/ mL Tolterodine Human Heparin Plasma LC- MS- MS 0.5 – 50 ng/ mL Tramadol* and 5- 200 ng/ mL M1* 1- 40 ng/ mL Tramadol* and 1 250 ng/ mL M1* 0.5 125 ng/ mL 10- 400 ng/ mL 10- 400 ng/ mL Tramadol* and 10 – 1000 ng/ mL O- Desmethyltramadol* 10 – 1000 ng/ mL N- Desmethyltramadol* 10...
author: Information Systems
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...
ANDA Approvals June 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - June 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-453 DIHYDROERGOTAMINE MESYLATE INJECTION, USP 1 MG/ML PACKAGED IN 1 ML SINGLE-DOSE VIALS - BEDFORD LABORATORIES 6/9/2003- 2 75-992 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN...
author: OGD
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
Tentative Approvals - September 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - September 2002 - ANDA Number Generic- Drug Name APPLICANT Tentative Approval Date 1 76-138 CIPROFLOXACIN TABLETS, USP 250 MG, 500 MG, AND 750 MG TECHNILAB PHARMA, INCVINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML PACKAGED IN 10 MG...
author: OGD
ANDA Approvals February 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - February 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-028 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG/ML AND 50 MG/5 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
Efficacy Supplements Approved in Calendar Year 2002 (SE1-SE7 AND SE8s ----------- This list is updated quarterly.- Updated through 12/31/02 -------------------- Top of Page ---------- EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2002 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER SUPP TYPE SUPP NUMBER RECEIPT DATE APPROVAL DATE PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ABACAVIR SULFATE, LAMIVUDINE, AND ZIDOVUDINE GLAXOSMITHKLINE 21-205 SE8...
author: Darlene Norris
Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) -------------------- Top of Page -------- Last Updated on 1/28/02 ---- --- By CDER.USER EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2001 (SE8)* Top of Page GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPP TYPE SUPP NUMBER PRIORITY REVIEW TOTAL APPROVAL TIME (MONTHS) ADENOSINE FUJISAWA HLTHCARE 20-059 11-Aug-99 31-Aug-01 SE8 007 N 24.7 ATORVASTATIN CALCIUM PFIZER...
author: Darlene Norris
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
