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,...
Prescription and Over-the-Counter Drug Product List: 8/2003 4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >D> AB2 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >D> TRANSDERM-NITRO >D> AB2 + NOVARTIS 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >A> @ 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >D> AB2 + 0.2MG/HR N20144 002 FEB 27, 1996 AUG DISC >A> @ 0.2MG...
author: AUTHOR
FDA Drug Approvals List April 2002 - Drug Approvals for April 2002 Definitions and Notes Original New Drug Applications Original Application #: 021310 Approval Date: 05-APR-02 Trade Name: ALORA Chemical Type: 3 Therapeutic Potential: S Dosage Form: PATCH, CONTROLLED RELEASE Applicant: WATSON LABORATORIES INC Active Ingredient(s): ESTRADIOL OTC/RX Status: RX Indication(s): For the prevention of postmenopausal...
Prescription and OTC Drug Product List 1/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA KV PHARM 500MG/15ML;7.5MG/15ML N40366 001 JAN 23, 2002 JAN NEWA AMPHOTERICIN B INJECTABLE, LI COMPLEX; INJECTION ABELCET -A- + ELAN PHARMS 5MG/ML N50724 001 NOV 20, 1995 JAN CAHN -D- + LIPOSOME 5MG/ML N50724 001 NOV 20, 1995 JAN...
Prescription and OTC Drug Product List 8/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 8: August 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE TABLET; ORAL TABLET; ORAL - ADD - BUTALBITAL, ACETAMINOPHEN AND CAFFEINE MODURETIC 5-50 - ADD - AB...
Prescription and OTC Drug Product List 11/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 11: November 1999 [ Prescription - OTC ] - ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE BUPROPION HYDROCHLORIDE SOLUTION; INHALATION TABLET; ORAL ALBUTEROL SULFATE - ADD - BUPROPION HCL - ADD - AN MORTON GROVE EQ 0.083% BASE N75394 001 - ADD - AB TEVA...
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...
Some Trade Names of Generic 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 - Some Trade Names of...
Specificity Table TOX.xls page 26
author: Biosite Incorporated
D:\WPFILES\NDA\TIGAN PRODUCTS\N17-531 Tigan Capsules\S-10 AP ltr 12\ -6-01.doc NDA 17- 531/ S- 010 Tigan ® (trimethobenzamide hydrochloride) Capsules/ Suppositories/ Injectable DESCRIPTION Chemically, trimethobenzamide HCl is N-[ p-[ 2-( dimethylamino) ethoxy] benzyl]- 3,4,5- trimethoxybenzamide monohydrochlorideTigan" and an opaque purple body marked "M079"
author: Melaine Shin
D:\WPFILES\NDA\TIGAN PRODUCTS\N17-531 Tigan Capsules\S-10 AP ltr 12\ -6-01.doc page 3
author: Melaine Shin
Tigan NDA 17- 531/ S- 010 Tigan ® (trimethobenzamide hydrochloride) Capsules/ Suppositories/ Injectable DESCRIPTION Chemically, trimethobenzamide HCl is N-[ p-[ 2-( dimethylamino) ethoxy] benzyl]- 3,4,5- trimethoxybenzamide monohydrochlorideTigan" and an opaque purple body marked "M079"
author: FDA.CDER
Tigan page 3
author: FDA.CDER
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt TRIMETHOBENZAMIDE HCLHYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE" 13282 15-Oct-98...
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 CORPORATION
Paddock Laboratories, Inc. - Other RX's BACITRACIN USP STERILE BELLADONNA & OPIUM SUPPOSITORIES COLISTIN SULFATE USP POWDER COLOCORT® Hydrocortisone Rectal Suspension, USP (Retention) COMPRO™ Prochlorperazine Suppositories, USP 25mg DEXAMETHASONE SODIUM PHOSPHATE USP POWDER HYDROCORTISONE ACETATE USP MICRONIZED POWDER HYDROCORTISONE ACETATE SUPPOSITORIES (Hemorrhoidal HC Suppositories) HYDROCORTISONE USP...
Paddock Laboratories, Inc. - Master Product List USP (Enteric-Coated Yellow) OTC 0004-01 0004-10 0004-11 5 mg - 100's 5 mg - 1000's 5 mg - U/D 100's - - - [C]--PRODUCTS-- Rx or OTC NDC 0574- Strength / Size MSDS Secundum Artem Issues Biblio- graphy Listing CASTOR OIL USP OTC 3312-02 2 oz Vol 3 No 4 ; Vol 5 No 3 ; Vol 10 No 2 - COLISTIN SULFATE USP POWDER Rx 0417-01 1 BU ** - - COLLODION, FLEXIBLE USP OTC 0560-04 4 oz - - - COLOCORT...
ANDA Approvals - August 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - August 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-080 AMOXICILLIN TABLETS FOR ORAL SUSPENSION 200 MG AND 400 MG - RANBAXY LABORATORIES LIMITED 8/11/2003- 2 76-134 LORATADINE TABLETS (OTC) 10 MG - RANBAXY LABORATORIES LIMITED 8/18/2003- 3 76-453 LIDOCAINE...
Paddock Laboratories, Inc. - Suppositories ASPIRIN SUPPOSITORIES USP BELLADONNA & OPIUM SUPPOSITORIES BISACODYL SUPPOSITORIES USP COMPRO™ Prochlorperazine Suppositories, USP 25mg ENCORT™ (Hydrocortisone Acetate Suppositories) 30mg HYDROCORTISONE ACETATE SUPPOSITORIES (Hemorrhoidal HC Suppositories) HYDROMORPHONE HCL SUPPOSITORIES MORPHINE SULFATE SUPPOSITORIES PHENADOZ (Promethazine HCl Suppositories USP)...
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 325MG;7.5MG...
Prescription and OTC Drug Product List 2/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST AMOXICILLIN; CLAVULANATE POTASSIUM FOR SUSPENSION; ORAL AUGMENTIN '400' -D- + GLAXOSMITHKLINE 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD -A- 400MG/5ML;EQ 57MG BASE/5ML N50725 002 MAY 31, 1996 FEB CRLD AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET; ORAL ...
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 25 Iu Somatropin Pituitary & Recombinant 0.20 ru Soybean Oil Emulsion 3.13 mL Spectinomycin HCl 57.00 mg Streptokinase 21428.00 IU Streptokinase- Streptodornase (Local) Streptokinase- Streptodornase 0 Streptomycin Sulfate Streptozocin Succinylcholine Chloride Sufentanil citrate Invert Sugar Invert Sugar in Sodium Chloride Sulbactam Sodium Sulfadiazine Sodium Sulfamethoxazole &...
author: FDA / CBER
subject: December 1987 Guideline
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 page 9
author: FDA / CBER
subject: December 1987 Guideline
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf M e t h a d o n e: Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered ...
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf page 2 PERFORMANCE CHARACTERISTICS A. Accuracy For each individual drug screen assay, approximately 60 urine samples of specific drugs were obtained form clinical laboratories. The concentration of drug present in the samples was determined by either GC/ MS or commercial kits. Each sample was then ...
