http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROM YCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Paclitaxel to Rosiglitazone Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Paclitaxel to Rosiglitazone Generic Trade Name Paclitaxel TAXOL Pamidronate AREDIA Pancrelipase PANCREASE, VIOKASE Pancuronium PAVULON Papaverine PAVABID Paramethadione PARADIONE Paramethasone HALDRONE Pargyline EUTONYL Paromomycin HUMATIN Paroxetine PAXIL Penbutolol LEVATOL Penciclovir DENAVIR...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, ABBOKINASE to BUTAZOLIDIN Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS ABBOKINASE to BUTAZOLIDIN Trade Name Generic ABBOKINASE Urokinase ACCOLATE Zafirlukast ACCUPRIL Quinapril ACCUTANE Isotretinoin ACHROMYCIN V Tetracycline ACTHAR Corticotropin (ACTH) ACTIFED *Triprolidine ADALAT Nifedipine ADENOCARD Adenosine ADRIAMYCIN Doxorubicin ADVIL Ibuprofen AFRIN...
THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Paclitaxel to Rosiglitazone Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Paclitaxel to Rosiglitazone Generic Trade Name Paclitaxel TAXOL Pamidronate AREDIA Pancrelipase PANCREASE, VIOKASE Pancuronium PAVULON Papaverine PAVABID Paramethadione PARADIONE Paramethasone HALDRONE Pargyline EUTONYL Paromomycin HUMATIN Paroxetine PAXIL Penbutolol LEVATOL Penciclovir DENAVIR...
Esoterix, Inc. -- Test Menu vivax) 300523 Platelet Antibody, Direct 300521 Platelet Antibody Drug-Induced *** 300520 Platelet Antibody Screen, Indirect (HLA, Platelet Glycoprotein) 500679 Platelet Count 300504 Platelet Factor 4 300805 Platelet Neutralization Procedure 300524 Platelet Specific Antibody (GP IIb/IIIa) 300526 Platelet Specific Antigen PLA1 (HPA-1a) 300531 Platelet Specific Antigen-2 (PLA2)...
author: Esoterix, Inc.
What's new at CDER by Date - U.SPseudoephedrine HCI Extended-Release Tablets, Impax Laboratories, Tentative Approval News Along the Pike; January-February 2004 [ HTML ] or [ PDF ] Orange Book Query Warning Letters and Notice of Violation Letters to Pharmaceutical Companies February 26, 2004 Drug Shortages; Resolved:...
author: Paul Stauffer
Prescription and Over-the-Counter Drug Product List: 1/2004 ADULT >A> + AAIPHARMA LLC 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL ;15MG/VIAL;0.005MG/VIAL;0.6MG/VIAL; 40MG/VIAL;6MG/VIAL;3.6MG/VIAL;6MG/V IAL;1MG/VIAL;10MG/VIAL;0.15MG/VIAL N21625 001 JAN 30, 2004 JAN NEWA BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED; TOPICAL BETAMETHASONE DIPROPIONATE >A> AB ATRIX EQ 0.05% BASE N76603 001 JAN 23, 2004 JAN NEWA BUPROPION HYDROCHLORIDE TABLET, EXTENDED...
Drug Approvals - M ANDA 75-586 5/30/02 - - - Metaproterenol Sulfate Inhalation Solution USP, 0.6%, Rx Novex Pharma ANDA 75-403 2/28/01 3/6/01 - - Metaproterenol Sulfate Inhalation Solution USP, 0.4%, Rx Novex Pharma ANDA 75-402 2/28/01 3/6/01 - - Metaproterenol Sulfate Syrup USP, 10 mg/5 mL, Rx Novex Pharma ANDA 75-235 1/27/00 2/4/00 - - Metaxalone Tablets, 400mg, Rx Tentative...
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...
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 Ventolin Albuterol ...
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...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls PROSINTEX SPA ALLOPURINOL UPJOHN MANUFACTURING CO MOTRIN TAB NOVUS FINE CHEMICALS, LLC PSEUDOEPHEDRINE HCL, SULFATE, AND BASE BULK POWDER TEVA PHARMACEUTICAL FINE CHEMICALS S.R.LSULFATE FABBRICA ITALIANI SINTETICI SPA FUROSEMIDE DINAMITE DIPHARMA SPA TRIAMTERENE USP XIX/BP '73 DINAMITE...
http://www.fda.gov/cder/dmf/text/4Q2003NEWTEXT.txt PETERSBURG, FL." 16976 II 25-Nov-2003 TARO PHARMACEUTICAL INDUSTRIES LTD "ONDANSETRON HYDROCHLORIDE AS MANUFACTURED IN HAIFA BAY, ISRAEL." 16977 II 21-Nov-2003 CHENG FONG CHEMICAL CO LTD "PSEUDOEPHEDRINE HYDROCHLORIDE AS MANUFACTRUED IN TAO YUAN HSIEN, TAIWAN." 16978 II 19-Nov-2003 CARDINAL HEALTH "RISPERIDONE 0.5 MG AND 1.0 MG ORALLY DISINTEGRATING TABLETS AS MANUFACTURED IN...
http://www.fda.gov/cder/dmf/xls/4Q2003NEWEXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003NEWEXCEL DMF # Type SUBMIT DATE HOLDER SUBJECT IV COGNIS DEUTSCHLAND GMBH CO KG MYRITOL(R) 318 PH AS MANUFACTURED IN DUESSELDORF, GERMANYSULFATE, USP STERILE AS...
PMS International EXPORT DIVISION LICENSING DIVISION EASTERN EUROPE DIVISION EXPORT CATALOG (PDF - Sorted by System) EXPORT CATALOG (PDF - Alphabetically sorted) LICENSING CATALOG EASTERN EUROPE CATALOG - - The following products are presently supplied to the customers in Eastern Europe: PMS BRAND NAME OTHER NAME OR COMPOSITION - DOSAGE FORM - PACK SIZE - AMITRIPTYLIN Amitriptylin 10 mg or 25 mg - -...
Prescription and Over-the-Counter Drug Product List: 11/2003 ACTHAR GEL >D> BC + QUESTCOR PHARMS 80 UNITS/ML N08372 008 NOV CTEC >A> + 80 UNITS/ML N08372 008 NOV CTEC CYTARABINE INJECTABLE; INJECTION >D> CYTARABINE >D> AP + GENSIA SICOR PHARMS 100MG/VIAL N16793 001 NOV DISC >D> AP + 500MG/VIAL N16793 002 NOV DISC >D> AP + 1GM/VIAL N16793 003 DEC 21, 1987 NOV DISC >D> AP + 2GM/VIAL N16793 004 DEC 21, 1987 NOV DISC >A> @ SICOR PHARMS 100MG/VIAL...
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 SULFATE ...
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
CDER Template - Replace Title Here Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Tentative Approvals - July 2002 - ANDA Number Drug Name Applicant Tentative Approval- Date 1 75-706 LORATADINE AND PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS-------- 10 MG/240 MG (24-HOUR FORMULATION) ANDRX PHARMACEUTICALS, LLC 7/9/02 2 75-919 MOMETASONE FUROATE...
author: USERNAME
First-Time Generics - January 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - January 2003 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 STRONTIUM CHLORIDE Sr-89 INJECTION, USP 1 mCi/Ml BIO-NUCLEONICS PHARMA, INC
author: OGD
ANDA Approvals January 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - January 2003 - ANDA Number- Generic Drug Name Applicant Approval Date 1 40-474 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MG ABLE LABORATORIES, INC
author: OGD
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, INC
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
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
