1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information OfficeBenzedrine (Amphetamine Sulate) Tablets , 5 mg & 10 mg Smith Kline & French Laboratories 83900 2/26/1976 12/6/2001 Biaxin (Clarithromycin) Tablets [783 KB] Abbott Laboratories...
83-900_Benzedrine (Amphetamine Sulfate) Tablets Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Benzedrine ( Amphetamine Sulfate) Tablets Company:--SmithKline & French Laboratories Application No.:--83-900 Approval Date:-2/26/1976 - Approval Letter(s) - Printed Labeling - Chemistry Review(s) - Bioequivalence Review(s) Administrative Document(s) - Correspondence ...
author: Paul Stauffer
1997 Abbreviated New Drug Applications (Generic Drugs) Generic Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information OfficeBenzedrine (Amphetamine Sulfate) Tablets SmithKline & French Laboratories 83-900 2/26/1976 12/17/2001 Benztropine Mesylate Tablets [10.9 MB] Rosemont Pharmaceutical Corp
Drugs of Abuse Reference Guide for pdf.indd LabCorp LabCorp Standard Standard GC/ MS Screening Confi rmation Drug Cut- off Level Cut- off Level Detection Time in Urine Stimulants Amphetamine/ Methamphetamine 1000 ng/ mL 500 ng/ mL 1 to 2 days Also known as: speed, ice, crystal, crank, eve (MDEA) Pharmaceutical Names: Dexedrine, Benzedrine, Desoxyn, Methedrine Methylenedioxymethamphetamine (MDMA) 500 ng/ mL 250 ng/...
author: willid2
Drug Testing Quarterly - Spring 2000 - [ Why Test For CreatinineAmphetamine & Methamphetamine - Classification: Stimulant Background: Methamphetamine and amphetamine belong to a group of structurally related drugs called sympathomimetic amines (SMAs) that are brain stimulantsAmphetamine was first introduced in...
Norchem Methamphetamine/Amphetamine Fact Sheet URINE DRUG TEST FACT SHEET METHAMPHETAMINE / AMPHETAMINE Classification: Stimulant Background: Methamphetamine and amphetamine belong to a group of structurally related drugs called sympathomimetic amines (SMAs) that are central nervous system stimulantsAmphetamine: Dexedrine, Benzedrine, ...
author: indigo8 - http://www.indigo8.com
Norchem Drug Testing - Drug Index Drug Index List of Abused Drugs - Stimulants Drug Name Trade Names Amphetamine Benzedrine, Dexedrine - - Methamphetamine Desoxyn, Methedrine, Gradumet - - Cocaine None - - Hallucinogens - Drug Name Trade Names Cannaboids Dronabinol, Marinol (Marijuana, THC) - - - LSD None (Lysergic Acid Diethylamide) - - - Mescaline None (Peyote) - - - Phencyclidine None (PCP) - - -...
author: indigo8 - http://www.indigo8.com
NUMERICAL INDEX NUMERICAL INDEX 000455 see Thyroid Panel 000620 see Thyroid Panel With TSH 000679 see Hemoglobinopathy Profile 000703 see Renin Activity and Aldosterone 000810 see Vitamin B12 and Folates 001016 see Calcium, Serum 001024 see Phosphorus, Serum 001032 see Glucose, Serum 001040 see Urea Nitrogen, Serum 001057 see Uric Acid, Serum 001065 see Cholesterol, Total 001073 see Protein, Total,...
Drug Approvals - D ANDA 76-137 1/18/02 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx Mutual Pharmaceutical CoAmphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, Rx Abrika Pharmaceuticals ANDA 40-472 9/30...
Drug Approvals - A ANDA 75-382 4/30/99 5/4/99 - - ADDERALL (Mixed Salts of a Single-Entity Amphetamine Product) Tablets, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg TabletsAmphetamine Product) Tablets, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg, Rx Shire Pharmaceutical Development...
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/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,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 15258 23-Jan-01 ISOCHEM SA "EPAL-NCA AS MFG IN VERT-LE-PETIT, FRANCE" 15259 22-Jan-01 SANOFI CHIMIE "FONDAPARINUX SODIUM AS MFG IN SISTERON (CEDEX) AND NOTRE DAME DE BONDEVILLE, FRANCE" 15261 24-Jan-01 TEVA GROUP "AZITHROMYCIN AS MANUFACTURED IN BE'ER SHEVA AND PETACH TIQVA, ISRAEL" 15262 05-Feb-01 DIOSYNTH BV "RECOMBINANT HUMAN INSULIN AS MFG IN THE NETHERLANDS, FRANCE, AND ISRAEL."...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls BISACODYL ROCHE DIAGNOSTICS GMBH DIGOXIN PRODUCTS SOLMAG S.P.A DICYCLOMINE HYDROCHLORIDE CHATTEM CHEMICALS INC AMPHETAMINE BULK AND DEXTRO DESOXYEPHEDRINE TAKEDA CHEMICAL INDUSTRIES LTD FOLIC ACID AVENTIS PHARMA SA NORGESTERAL ACETATE OXIME INDUSTRIA CHIMICA MILANESE SPA PROCHLORPERAZINE BASE,PROCHLORPERAZINE MALEATE ANTIBIOTICOS SPA GLIPIZIDE, BULK STARKS ASSOCIATES INC...
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 ...
510(k)s Final Decisions Rendered for October 2003 FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH 510(k)s Final Decisions Rendered for October 2003 Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities
author: CDRH/ODE
ANDA Approvals - October 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - October 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-416 WARFARIN SODIUM TABLETS, USP 1 MG, 2 MG, 2.5 MG, 3 MG 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG - UPSHER-SMITH LABORATORIES, INCAMPHETAMINE AND DEXTROAMPHETAMINE TABLETS ...
Prescription and Over-the-Counter Drug Product List: 9/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG;10MG...
author: AUTHOR
ANDA Approvals May 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - May 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 75-681 MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/ML COPLEY PHARMACEUTICAL, INCSULFATE EXTENDED-RELEASE CAPSULES 5 MG, 10 MG, AND 15 MG MALLINCKRODT INC
author: OGD
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
ANDA Approvals February 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - February 2002 - ANDA Number Drug Name Applicant Approval Date 1 75-810 FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) BARR LABORATORIES, INC
author: USERNAME
Prescription and Over-the-Counter Drug Product List: 1/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE -A- SOLUTION; ORAL -A- ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE -A- + MIKART 325MG/15ML;50MG/15ML;40MG/15ML N40387 001 JAN 31, 2003 JAN NEWA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPAHTE -A- AA ANDRX PHARMS 300MG;15MG N40443 001 JAN 22, 2003 JAN NEWA -A- AA...
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
NDA Approvals for Calendar Year 2001 Braun 5 S 21-Feb-01 21-235 Prozac Weekly Fluoxetine Hydrochloride Eli Lilly 3 S 26-Feb-01 21-169 Reminyl Galantamine Hydrobromide Janssen Research 1 S 28-Feb-01 21-082 Tavist Allergy/Sinus/Headache Acetaminophen/Clemastine Fumarate/Pseudoephedrine Hydrochloride Novartis 4 S 01-Mar-01 21-257 Travatan Travoprost Alcon 1 P 16-Mar-01 21-262 Alphagan P Brimonidine Tartrate Allergan 3 S 16...
author: Brenda Harmon
FDA Drug Approvals List October 2001 - Drug Approvals for October 2001 Definitions and Notes Original New Drug Applications Original Application #: 021356 Approval Date: 26-OCT-01 Trade Name: VIREAD Chemical Type: 1 Therapeutic Potential: P Dosage Form: TABLET Applicant: GILEAD SCIENCES INC Active Ingredient(s): TENOFOVIR DISOPROXIL FUMARATE OTC/RX Status: RX Indication(s): For use in combination with other...
