http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
EFFICACY SUPPLEMENTS APPROVED IN CALENDAR YEAR 2003 *Supplement Type Description for SE1 - SE7 N (Chemical Type 6) SE1 SE2 SE3 SE4 SE5 SE6 SE7 NDA Type 6 - New Indication New or modified indication New dosage regimen New route of administration Comparative efficacy claim Patient population altered Change the marketing status from prescription to over the counter use Complete the traditional approval of a product originally approved...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4Q2003 TYPE2ACTIVETEXT DMF # SUBMIT DATE HOLDER SUBJECT 131 01-Jan-40 CENTRAL SOYA SOYBEAN STEROL PRODUCTS 183 29-Feb-52 INTERNATIONAL SPECIALTY PRODUCTS POLYVINYL PYRROLIDONE-IODINE 10 191 24-Jan-56 MALLINCKRODT CHEMICAL INC PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) 240 11-Jan-57 PHARMACIA & UPJOHN 19-NOR-ETHINYLTESTOSTERONE 281 21-Nov-57 UNIMED PHARMACEUTICALS INC 2 HYDROXY...
lan;02dec00 SEMINAR THE LANCET ° Vol 356 ° December 2, 2000 1913 After the introduction of combined oral contraceptives (OCs) brought about the revolution of sex without fear of pregnancy 40 years ago, there is still demonstrable unmet need.
author: bos
Gender-Specific Healthcare - About Berlex | Contact Us | Feedback | Site Map | Search - Patients Healthcare Professionals Clinical Trials Home - Research & Development > Current Development Gender-Specific Healthcare While two contraceptive pills with ultra-low-dose estrogen content are already available today, another oral contraceptive containing a progestin and only 15 micrograms of ethinyl ...
FDA Drug Approvals List May 2001 - Drug Approvals for May 2001 Definitions and Notes Original New Drug Applications Original Abbreviated Application # 075312 Approval Date: 31-MAY-01 Trade Name: FAMOTIDINE Dosage Form: TABLET Applicant: TEVA PHARMACEUTICALS USA INC Active Ingredient(s): FAMOTIDINE OTC/RX Status: OTC Original Abbreviated Application # 040419 Approval Date: 31-MAY-01 Trade Name: ACETAMINOPHEN AND...
C:\Data\My Documents\Yasmin\GoodbyeKissTVNOV.doc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 TRANSMITTED BY FACSIMILE Nancy Konnerth Associate Director, Advertising and Labeling Drug Regulatory Affairs Berlex Laboratories 340 Changebridge Road Pethinyl estradiol) Tablets MACMIS ID...
author: Joan Hankin
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author: Joan Hankin
http://www.fda.gov/cder/foi/label/2003/21098se8-005_yasmin_lbl.pdf 1 Rx only PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT AGAINST HIV INFECTION (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES YASMIN ® 28 Tablets (drospirenone and ethinyl estradiol) DESCRIPTION YASMIN provides an oral contraceptive regimen consisting of 21 active film coated tablets each containing 3.0 mg of drospirenone and 0
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Evidence based medicine research - health services management EVIDENCE BASED MEDICINE Health Services Management - Health Services Research Bibliography Manuscripts In Press - Publications by Year: - 2003 1999 1994 1989 1984 2002 1998 1993 1988 1983 2001 1997 1992 1987 1977 2000 1996 1991 1986 1976 1995 1990 1985 - Publications Submitted/ In Review - - - - - - - - - - - - - - - - Manuscripts In Press Badamgarav E, Croft JD, Hohlbauch A, Louie...
02-002 PhRMA NDA 2001 1/24 monthly vaginal ring 12/ 28/ 99 10/ 3/ 01 21.2 months none etonogestrel/ West Orange, NJ for birth control ethinyl estradiol vaginal ring (S) For more information contact: Patrick Jethinyl estradiol ...
author: RL
02-002 PhRMA NDA 2001 1/24 page 10
author: RL
Schering: Our research fields? information on Schering AG ...
author: ršttjer:seifert gmbh
Prescription and OTC Drug Product List 5/2001 Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
Yasmin Consumer Information Yasmin® Brand Name: Yasmin® Active Ingredient: - drospirenone 3.0mg and ethinyl estradiol 0.030mg Dosage Form(s): - Tablets Company Name: -- Berlex Laboratories, Inc
