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,...
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
Box 1000 Montville, NJ 07045- 1000 RE: NDA 21- 098 Yasmin (drospirenone/ ethinyl estradiol) Tablets MACMIS ID# 11730 Dear Ms Konnerth: This letter notifies Berlex Laboratories (Berlex) that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has identified a direct- to- consumer (DTC) broadcast advertisement (TV ad) for Yasmin ...
author: Joan Hankin
C:\Data\My Documents\Yasmin\GoodbyeKissTVNOV.doc page 1
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 The...
http://www.fda.gov/cder/foi/label/2003/21098se8-005_yasmin_lbl.pdf page 21
http://www.fda.gov/cder/foi/label/2003/21098se8-005_yasmin_lbl.pdf page 16
http://www.fda.gov/cder/foi/label/2003/21098se8-005_yasmin_lbl.pdf page 3
http://www.fda.gov/cder/foi/label/2003/21098se8-005_yasmin_lbl.pdf page 2
http://www.fda.gov/cder/foi/label/2003/21098se8-005_yasmin_lbl.pdf page 1
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
NDA FDA Review Foreign Product Company Indication/Use Received Approved Time Availability* Travatanª Alcon Laboratories reduction of elevated 7/ 7/ 00 3/ 16/ 01 8.3 months USA first travoprost Fort Worth, TX intraocular pressure in marketing ophthalmic patients with open- angle solution glaucoma or ocular (P) hypertension For more information contact: Mary Dulle, (817) 551- 8058...
author: RL
02-002 PhRMA NDA 2001 1/24 page 10
author: RL
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, IncDrospirenone can increase potassium in your blood Women should not use Yasmin if they have kidney, liver, or adrenal disease because it can cause serious health...
http://www.schering.de/eng/investorrelationsforum/irpresentations/am_day_plus/pdfs/analystconf2002.pdf
Analyst Meeting Berlin, March 1, 2002 ...
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. Therefore, this method is not generally recommended for young women in whom compliance can be poor. 33 New users, especially young men, need...
author: bos
http://www.fda.gov/cder/foi/label/2003/21098se8-005_yasmin_lbl.pdf page 14
Schering: Our research fields?
information on Schering AG ...
author: rttjer:seifert gmbh
Combination hormonal birth control methods (pills, patch, or ring) - [Medication] - Quest Diagnostics Patient Health Library
Topic Contents - Examples - How It Works - Why It Is Used - How Well It Works - Side Effects - What To Think About - References Combination hormonal birth control methods (pills, patch, or ring) - [Medication] - Quest Diagnostics Patient Health Library Combination hormonal birth control methods (pills, patch, or ring) - [Medication] - Quest Diagnostics Patient Health Library Hormones...
BioPortfolio Limited
focus of concern shifts towards the UK 70 Market analysis: leading and new product sales to 2008 71 Wyeth 73 Premarin family (conjugated estrogens) 73 Novartis 79 Schering AG 79 Climara and Climara Pro (estradiol) 80 Avaden (estradiol/gestodene) 81 Solvay 82 Estratest (esterified estrogens/methyltestosterone) 82 Organon 83 Novo Nordisk 84 Outlook for the HRT market 85 Unmet...
http://www.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/Contraception/UTD-Oral.pdf
Soon thereafter, ethinyl substitution of testosterone also was found to result in an orally active compound (ethisterone). However, individual women have had been reported to have significant decreases in the plasma concentrations of ethinyl estradjo] when taking certain other antibiotics, such as tetrqs; ys'li~, pbnicillin derivatives, and cephalosporins [1; 1,,; 1,3]...
author: floerchingerd [ M68498 ]