Drug Approvals - D NDA 50-704/S-008 2/21/02 2/22/02 Daypro ALTA (oxaprozin potassium) Tablets, 600mg- Pharmacia Corporation NDA 20-776 10/17/02 10/21/02 11/19/02 - Daypro (Oxaprozin) Caplets, 600 mg G.DDaypro (oxyprozin) Caplets, 600 mg--- Pharmacia Corporation- NDA 18-841/S-020 4/9/03 4/16/03 4/16/03 DDAVP ...
http://www.fda.gov/cder/orange/appendix_a.txt 45, DIHYDROERGOTAMINE MESYLATE DACARBAZINE, DACARBAZINE DALGAN, DEZOCINE DALMANE, FLURAZEPAM HYDROCHLORIDE DANAZOL, DANAZOL DANOCRINE, DANAZOL DANTRIUM, DANTROLENE SODIUM DAPSONE, DAPSONE DARANIDE, DICHLORPHENAMIDE DARAPRIM, PYRIMETHAMINE DARBID, ISOPROPAMIDE IODIDE DARICON, OXYPHENCYCLIMINE HYDROCHLORIDE DARVOCET A500, ACETAMINOPHEN DARVOCET, ACETAMINOPHEN DARVOCET-N 100,...
C:\N20776\N20776APwFPL.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 20776 Pharmacia Corporation Attention: Susan Tegtmeyer Manager, Global Regulatory Affairs 4901 Searle Parkway Skokie, Illinois, 60077 Dear Ms
author: Nancy Halonen
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C:\N20776\N20776APwFPL.doc NDA 20776 Page 3 PHARMACIA Daypro ALTA ™ (oxaprozin potassium tablets) DESCRIPTION Daypro ALTA (oxaprozin potassium tablets) is a member of the propionic acid group of nonsteroidal antiinflammatory drugs (NSAIDs)Daypro ALTA, the potassium salt of oxaprozin, is a...
author: Nancy Halonen
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Specificity Table TOX.xls Tested (ng/ ml) Darvon Propoxyphene (Dextropropoxyphene) Narcotic analgesic 100,000 Darvon metabolite Propoxyphene metab.( Norpropoxyphene) Propoxyphene metabolite 100,000 Daypro Oxaprozin Anti- inflammatory 100,000 Death PMA (paraMethoxyamphetamine) Amphetamine analog 100,000 AMP 2,500 Decadron Dexamethasone Anti- inflammatory 100,000 Declinax Debrisoquin...
author: Biosite Incorporated
1997 Warning Letters and Notice of Violation Letters to Pharmaceutical Companies DDMAC 3/14/1997 Sporanox (itraconazole capsules) Janssen Pharmaceutica DDMAC 3/27/1997 Ultane (sevoflurane) Abbott Laboratories DDMAC 3/17/1997 April 1997 Androgel (Testosterone) Gel Unimed Pharmaceuticals DDMAC 4/25/1997 Caverject (alprostadil) for injection Pharmacia and Upjohn Company DDMAC 4/28/1997 Cutivate (Fluticasone Propionate) Cream Glaxo Wellcome DDMAC - Daypro (...
C:\N18841\S-020ApprovalLtr.doc NDA 18- 841/ S- 020 Page 3 Daypro ® oxaprozin caplets DESCRIPTION Daypro (oxaprozin) is a nonsteroidal anti- inflammatory drug (NSAID), chemically designated as 4,5- diphenyl2- oxazole- propionic acid, and has the following chemical structure: The empirical formula for oxaprozin is C18H15NO3, and the molecular weight is 293Daypro oral...
author: Nancy Halonen
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C:\Data\My Documents\18841S16&S12.doc 02/ 12F- 696 SEARLE Daypru® (oxaprozin) Caplets 604 mg DESCRIPTION Daypro (oxaprozin) is a nonstxroidal anti- inflammatory drug (NSAID), chemically designated as 4,5- diphenyl- 2 oxazole- propionie acid, and has the following chemical structure- O / 0 C H2 CH,- ON The empirical formula for oxaprozin iz ClaH1jNO3, and the molecular weight is 293
author: Carmen DeBellas
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author: Carmen DeBellas
http://www.fda.gov/cder/foi/label/2002/18841s12s16lbl.pdf January 25, 2002 1 SEARLE Daypro ® (oxaprozin) Caplets 600 mg DESCRIPTION Daypro (oxaprozin) is a nonsteroidal anti- inflammatory drug (NSAID), chemically designated as 4,5- diphenyl- 2- oxazole- propionic acid, and has the following chemical structure: The empirical formula for oxaprozin is C18H15NO3, and the molecular weight is 293Daypro ...
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FDA Drug Approvals List- January 1998 Dosage Form: INJECTABLE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): GONADOTROPIN, CHORIONIC OTC/RX Status: RX Application #: 020729 Labeling Supplement#: 002 To Original New Drug Application Approval Date: 21-JAN-98 Trade Name: UNIRETIC Dosage Form: TABLET Applicant: SCHWARZ PHARMA INC Active Ingredient(s): HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE OTC/RX Status...
DDPA April 1995 74-481 CAPTOPRIL INVAMED CAPTOPRIL 28-APR-95 (TABLET) DAYTON, NJ 12.5MG 08810 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-646 PERGONAL SERONO MENOTROPINS-- 05-APR-95 (INJECTABLE) BRAINTREE, MA FOLLICLE 02184 STIMULATING HORMONE 75IU/AMP LUTEINIZING HORMONE 75IU/AMP (LABELING REVISION -- ADVERSE REACTIONS) 17-646 PERGONAL...
DDPA February 1995 74-047 ZIDOVUDINE BARR ZIDOVUDINE 24-FEB-95 (C APSULE) POMONA, NY 100MG 10970 (ANTIVIRAL) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-970 NOLVADEX ZENECA PHARMS TAMOXIFEN CITRATE 01-FEB-95 (TABLET) WILMINGTON, DE EQ 10MG BASE 19850 (LABELING REVISION -- WARNINGS) 20-055 GLYBURIDE (MICRONIZED) HOECHST ROUSSEL GLYBURIDE 01-FEB-95 (TABLET) SOMERVILLE, NJ 1.5MG 08876 3MG (LABELING...
