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 OTC Drug Product List 3/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 3: March 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST LIST 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 3 / JAN'2000 - MAR'2000 ACETAMINOPHEN; BUTALBITAL AMINOPHYLLINE CAPSULE; ORAL TABLET; ORAL...
FDA Drug Approvals List October 2000 - Drug Approvals for October 2000 Definitions and Notes Original New Drug Applications Original Application #: 020958 Approval Date: 16-OCT-00 Trade Name: PEPCID COMPLETE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET, CHEWABLE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): CALCIUM CARBONATE, PRECIPITATED; FAMOTIDINE; MAGNESIUM HYDROXIDE...
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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt PETERSBURG, FL" 12840 02-Feb-98 GRUPPO LEPETIT SPA "OXYBUTYNIN CHLORIDE, MANUFACTURED IN GARESSIO,ITALY" 12848 05-Feb-98 JOHNSON MATTHEY INC "HYDROCODONE BITARTRATE, USP MANUFACTURED IN WEST DEPTFORD, NEW JERSEY." 12851 05-Feb-98 PFANSTIEHL LABORATORIES INC "DECITABINE, MANUFACTURED IN WAUKEGAN,IL." 12854 10-Feb-98 YAMANOUCHI PHARMACEUTICAL CO LTD "YM087 DRUG SUBSTANCE, MANUFACTURED...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls KG DOPAMINE HYDROCHLORIDE KYOWA HAKKO KOGYO CO LTD AMINO ACIDS MANUFACTURED AT UBE CITY PLANT JAPAN FABBRICA ITALIANI SINTETICI SPA INDOMETHACIN, USP FRANCIS INDUSTRIA CLIMICA PRODOTTI TOLBUTAMIDE RHONE POULENC PHARMACEUTICALS RP INC BULK ACETAMINOPHEN AS MANUFACTURED AT THE BARTON PLANT IN LULING, LA SYNTEX USA INC FLUNISOLIDE AS MANUF AT THE GRAND BAHAMA AND GUERNAVACA...
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, INCACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/60 MG ABLE LABORATORIES,...
author: OGD
1997 Abbreviated New Drug Applications (Generic Drugs) 040109 8/26/1997 4/27/1998 Acetaminophen -Codeine Phosphate Purepac Pharmaceutical 086683 -05/11/1979 8/4/2003 Acetaminophen -Codeine Phosphate Purepac Pharmaceutical 086681 -05/11/1979 8/4/2003 Acetazolamide Tablets USP, 125 mg and 250 mgAcetaminophen Tablets 5mg/500 mg and 7.5 mg/750 mg [1.2 MB] Halsey Drug...
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 +...
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...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG...
ranbaxy - - - - - - You are here :- Home - Products - - Dosage Forms - INDIA DOSAGE FORMS LIST- (Updated Jan 2002) Anti-infectives G.I. & Nutritionals CVS & Diabetes CNS NSAID & related Anti-allergants ...
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 ...
Prescription and OTC Drug Product List 9/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 9: September 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE ATENOLOL CAPSULE; ORAL TABLET; ORAL - DLT - BUTALBITAL, ACETAMINOPHEN, CAFFEINE ATENOLOL - DLT - AB GRAHAM DM 325MG;50MG;40MG N88758 001 - ADD -...
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock...
http://www.fda.gov/cder/foi/appletter/2000/74699ltr.pdf ANDA 74- 699 March 24, 2000 Watson Laboratories, IncPentazocine Hydrochloride and Acetaminophen Tablets, 25 mg (base)/ 650 mg
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C:\Data\My Documents\daccadp\n18458ap.012.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 18- 458/ S- 012 Sanofi- Synthelabo 90 Park Avenue New York, NY 10016 Attention: Eileen De Micco, MA Regulatory Specialist Dear Ms
author: Parinda Jani
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author: Parinda Jani
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