Specificity Table TOX.xls Tested (ng/ ml) Combipress Chlorthalidone Diuretic 100,000 Compazine Prochlorperazine Antiemetic 100,000 Contralac Metergoline Prolactin inhibitor 100,000 Cordarone Amiodarone Antiarrhythmic 100,000 Cordran Flurandrenolide Glucocorticoid 100,000 Cortazac Hydrocortisone Glucocorticoid 100,000 Cortazac metabolite Hydrocortisone metab.( Cortol, ss-) Hydrocortisone metabolite 100,000...
author: Biosite Incorporated
Specificity Table TOX.xls page 7
author: Biosite Incorporated
Drug Approvals - A This newly approved or tentatively approved drug listing is an interim page intended to provide timely information on new drug products as a more comprehensive page is developed
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 OfficeAmcinonide) ...
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 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...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls Arthur Shaw CDER User $ ($) $ ($) $ ($) $ ($) $ $ () $ - () - $ $ () $ - () - -- -- $ ($) $ ($) $ ($) $ ($) / / // -- - - : : :: : () () () () () - $ $ () $ - () - $ $ () $ - : :: : 4Q2003 TYPE2ACTIVEEXCEL DMF # SUBMIT DATE HOLDER SUBJECT CENTRAL SOYA SOYBEAN STEROL PRODUCTS INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE ...
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, 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
Prescription and Over-the-Counter Drug Product List: 4/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL FIORICET -D- AB + NOVARTIS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN ACYCLOVIR CAPSULE; ORAL ACYCLOVIR -A- AB AAIPHARMA 200MG N74833 001 APR 22, 1997 APR CAHN -D- AB AESGEN 200MG N74833 001 APR 22, 1997...
author: AUTHOR
OGD, First Time Approvals - May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - May 2002 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1- IDARUBICIN HYDROCHLORIDE FOR INJECTION, USP 5 MG, 10 MG, AND 20 MG SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
ANDA Approvals May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - May 2002 - ANDA Number Drug Name Applicant Approval Date 1 65-036 IDARUBICIN HYDROCHLORIDE INJECTION 1 MG/ML; (5 MG/5 ML, 10 MG/10 ML, AND 20 MG/20 ML SINGLE-DOSE VIALS) GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
First-Time Generics - November 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - November 2002 - Generic Drug Name Generic Manufacturer Brand Name Product Approval Date 1 OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG KREMERS URBAN DEVELOPMENT COMPANY PRILOSEC DELAYED-RELEASE CAPSULES 11/1/02 2 AMCINONIDE LOTION 0.1% ALTANA INC
author: OGD
ANDA Drug Approvals - November 2002 -U.SAMCINONIDE LOTION 0.1% ALTANA INC
author: OGD
ANDA Approvals March 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - March 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 40-455 NOREPINEPHRINE BITARTRATE INJECTION, USP 1 MG (BASE)/ML, PACKAGED IN 4 MG (BASE)/4 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
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
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
Prescription and OTC Drug Product List 11/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;5MG N40478 001 NOV 08, 2002 NOV NEWA -A- AA 500MG;10MG N40473 001 NOV 06, 2002 NOV NEWA -A- AA 500MG;5MG N40477 001 NOV 06, 2002 NOV NEWA AMCINONIDE LOTION; TOPICAL -A- AMCINONIDE -A- AB ALTANA 0.1% N76329 001 NOV 06, 2002 NOV NEWA CYCLOCORT -D- +...
http://www.adis.com/files/newsletters/REA/Rxcov893.pdf 5 Enoxaparin sodium and aspirin: haemorrhagic events after renal transplant 4 Mumps virus vaccine: residual virulence 4 Olanzapine: reduced risk of extrapyramidal syndrome 4 Adverse Reaction Case Reports Acenocoumarol/ citalopram interaction: increased INR [ X S] 6 Alendronic acid: fatal oesophageal perforation [S] 6 Amcinonide: allergic contact dermatitis 6 Amiodarone: lung...
Medicines, Ethics and Practice page 2
Glossary: Amcinonide Amcinonide Amcinonide is a medicament. This substance belongs to the group of corticosteroids. It is mainly used in case of inflammatory skin diseases and psoriasis. It can be found in creams, lotions or ...
