Wyeth: Products: Full Pharmaceutical Product List (A-Z) Ovral ® Tablets (0.5 mg norgestrel and 50 mcg ethinyl estradiol tablets) Prescribing Information Prescribing Information for this product may differ due to dose ranges or formulations.
Drug Approvals - O ANDA 76-093 12/5/01 4/16/03 Ogestrel 0.5/50-21 and Ogestrel 0.5/50-28 Tablets (Norgestrel and Ethinyl Estradiol Tablets USP, 0.5 mg and 0.05 mg, respectively) SCS Pharmaceuticals ANDA 75-406 - 12/15/99 - - Olux (clobetasol propionate) Foam, 0.05%, Rx Connetics Corporation NDA 21-142/S10 12/29/03 1/2/03 1/2/03 - Olux (clobetasol propionate) Foam, 0.05%, Rx Connetics...
http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
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
Tri-Cyclen Lo lg PI Table 1 provides a summary of norelgestromin, norgestrel and ethinyl estradiol pharmacokinetic parametersnorgestrel and ethinyl estradiol were 28.1 (± 10.6) hours, 36.4 (&...
author: Donna
Ortho Evra PI ORTHO EVRA ® (NORELGESTROMIN / ETHINYL ESTRADIOL TRANSDERMAL SYSTEM) Prescribing Information Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases
author: Mac10
Ortho Evra PI page 2
author: Mac10
1997 New Drug Application (NDA) 019710/S021 5/23/1997 Orudis and Oruvail Capsules Wyeth-Ayerst Laboratories 018754/S25 019816/S07 08/05/1997 9/11/2003 Ovral (Norgestrel & Ethinyl Estradiol) Tablets & Ovral -28 (Norgestrel & Ethinyl Estradiol) Tablets Wyeth-Ayerst Laboratories 16-672 & 16-806 8/14/1997 9/18/2001 Ovral (Norgestrel & Ethinyl Estradiol...
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay fever,...
http://www.fda.gov/cder/foi/label/2001/16806S28lbl.pdf OVRAL Tablets (NORGESTREL AND ETHINYL ESTRADIOL TABLETS) atients should be counseled that this product does not protect against HIV infection ( AIDS) and other se ually transmitted diseasesNorgestrel Ethinyl Estradiol Clinical harmacology C mbinati n ral c ntraceptives act by suppressi n f g nad tr pins
http://www.fda.gov/cder/foi/label/2001/16806S28lbl.pdf page 1
C:\Data\My Documents\My Documents\MERCIER\NDAS\LETTERS\21180ap.do\ c NDA 21- 180 Page 3 only ORTHO EVRA™ (NORELGESTROMIN / ETHINYL ESTRADIOL TRANSDERMAL SYSTEM) Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseasesethinyl estradiol ...
author: Jennifer L. Mercier
http://www.fda.gov/cder/foi/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf 1 Rapamune a a (sirolimus) Oral Solution and Tablets WARNING: Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression
http://www.fda.gov/cder/foi/label/2003/21110slr013,21083slr014_Rapamune_lbl.pdf page 16
http://www.fda.gov/cder/foi/label/2003/21110slr011,21083slr012_Rapamune_lbl.pdf CI- 7713 Rapamune 1 Rapamune ® (sirolimus) Oral Solution and Tablets WARNING: Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression
http://www.fda.gov/cder/foi/label/2003/21110slr011,21083slr012_Rapamune_lbl.pdf page 16
C:\Data\My Documents\My Documents\MERCIER\NDAS\LETTERS\21241ap.do\ c NDA 21- 241 Page 5 Table 1: Mean (SD) Pharmacokinetic Parameters of ORTHO TRI- CYCLEN ® Lo During a Three Cycle Study Analyte 1 Cycle Day Cmax tmax (h) AUC0- 24h t1/ 2 (h) NGMN (2- 4) 1 1 0.91 (0.27) 1.8 (1.0) 5.86 (1.54) NC 3 7 1.42 (0.43) 1.8 (0.7) 11.3 (3.2) NC 14 1.57 (0.39) 1.8 (0.7) 13.9 (3.7) NC 21 1.82 (0.54) 1.5 (0.7) 16.1 (4.8) 28.1( 10.6) NG (2- 4) 1 1 0.32 (0.14) 2.0...
author: Jennifer L. Mercier
http://www.fda.gov/cder/foi/appletter/2001/16672s46ltr.pdf page 1
duplicates:http://www.fda.gov/cder/foi/appletter/2001/16672S46LTR.PDF
75288.APP.LTR.BBC.DOC ANDA 75- 288 July 28, 1999 SCS Pharmaceuticals Attn: Doranne Frano 4901 Searle Parkway Skokie, IL 60077 Dear Madam: This is in reference to your abbreviated new drug application dated December 24, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Low- Ogestrel- 21 and Low- Ogestrel- 28 (Norgestrel and Ethinyl Estradiol ...
author: Unknown
75288.APP.LTR.BBC.DOC page 1
author: Unknown
Drug Approvals for August 1997 Drug Approvals for August 1997 Definitions and Notes August 1997 Original New Drug Applications Original Application #: 020808 Approval Date: 29-AUG-97 Trade Name: VISIPAQUE Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): IODIXANOL OTC/RX Status: RX Indication(s): Intra-arterial - for visceral intra-arterial digital...
http://www.fda.gov/cder/da/ddpa94.wpd 17 926 INSULIN NOVO NORDISK PHARMS INSULIN PORK 03 JAN 94 (INJECTABLE) PRINCETON, NJ 100 UNITS/ML 08540 (LABELING REVISION SYRINGES; NEEDLE-FREE INJECTORS) (OTC) 17 929 NPH INSULIN NOVO NORDISK PHARMS INSULIN SUSP ISOPHANE BEEF 03 JAN 94 (INJECTABLE) PRINCETON, NJ 100 UNITS/ML 08540 (LABELING REVISION SYRINGES; NEEDLE-FREE INJECTORS) (OTC) 17 996 SEMILENTE INSULIN NOVO NORDISK PHARMS...
233040 Seasonale The risks associated with taking oral contraceptives increase significantly if you: Rx only (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0.03 mg (levonorgestrel / ethinyl estradiol tablets) 0.15 mg / 0...
author: Mary
233040 Seasonale page 1
author: Mary
Pages Barr Laboratories, Inc.ethinyl estradiol for 84 consecutive days, followed by a sevenday interval during which placebo pills are taken to induce a withdrawal bleeding period.
author: Lisa
