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...
http://www.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/Contraception/UTD-Oral.pdf Pills containing less than 50 ~g of ethinyl estradiol have been referred to as "low- dose" pills.ethinyl estradiol with increasing doses of desogestrel (100, 125, and 150 ug days 1 to 7, 8 to 14, and 15 to 21, respectively).desogestrel, and gestodene (showtab...
author: floerchingerd [ M68498 ]
Ortho-McNeil: Our Products - ORTHO -CEPT ® Tablets (desogestrel/ethinyl estradiol) Contraceptive Combination oral contraceptive product containing 0.15mg desogestrel and 0.03mg ethinyl estradiol - ORTHO -CYCLEN ® Tablets (norgestimate/ethinyl estradiol) Contraceptive Combination contraceptive product containing 0.250mg norgestimate and 0.035mg ethinyl ...
Ortho-McNeil: Our Products - ORTHO -CEPT ® Tablets (desogestrel/ethinyl estradiol) Contraceptive Combination oral contraceptive product containing 0.15mg desogestrel and 0.03mg ethinyl estradiol ORTHO -CYCLEN ® Tablets (norgestimate/ethinyl estradiol) Contraceptive Combination contraceptive product containing 0.250mg norgestimate and 0.003mg ethinyl ...
Ortho-McNeil: Our Products Prescribing Information - ALL-FLEX ® Arcing Spring Diaphragm Contraceptive Molded, dry natural rubber vaginal diaphragm containing a distortion-free, dual spring-within-a-spring AXERT ® Tablets (almotriptan malate) Migraine Oral medication for acute treatment of migraine with or without aura in adults; available in 6.25mg and 12.5mg, 6-tablet blister - DITROPAN ® ...
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
Ortho-Cept PI DESCRIPTION ORTHO - CEPT 28 Tablets provide an oral contraceptive regimen of 21 orange round tablets each containing 0.15 mg desogestrel (13- ethyl- 11- methylene- 18, 19- dinor- 17 alpha- pregn- 4- en- 20- yn- 17- ol) and 0.03 mg ethinyl estradiol (19- nor- 17 alpha- pregna- 1,3,5 (10)- trien- 20- yne- 3, 17, diol)
author: Donna
Ortho-Cept PI page 1
author: Donna
FDA Drug Approvals List June 2001 PERRIGO COMPANY Active Ingredient(s): MONOXIDIL OTC/RX Status: RX Original Abbreviated Application # 075750 Approval Date: 8-JUN-01 Trade Name: DOXAZOSIN MESYLATE Dosage Form: TABLET Applicant: SIDMAK LABORATORIES, INC Active Ingredient(s): DOXAZOSIN MESYLATE OTC/RX Status: RX Original Abbreviated Application # 075502 Approval Date: 05-JUN-01 Trade Name: CLOTRIMAZOLE AND...
http://www.fda.gov/cder/foi/label/2001/20301S15lbl.pdf D SCRIPTION ORTHO - CEPT 21 a d ORTHO - CEPT 28 Tablets provide a co traceptive regime 21 ora ge rou d tablets each co tai i g .15 mg desogestrel ( 13- ethyl- 11- methyle e- 18, 19- di or- 17 alpha- preg 4- e 2 ol) a dORTHO - CEPT, maximum co ce tratio s of 3- keto- desogestrel of 2, 8 5 &...
D:\Data\My Documents\NDA\N20301S15APltr.doc page 1
author: Jeanine Best
Prescription and OTC Drug Product List 8/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
PDPL PRESCRIPTION DRUG PRODUCT LIST- 16TH EDITION RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 8 / JAN'96 - AUG'96 ACETAMINOPHEN; BUTALBITAL ALPRAZOLAM TABLET; ORAL TABLET; ORAL BUTALBITAL AND ACETAMINOPHEN ALPRAZOLAM - DLT - AB HALSEY 325MG;50MG N89568 001 - ADD - AB NOVOPHARM 2MG N74085 004 - DLT - OCT 05, 1988 - ADD - FEB 26, 1996 - ADD - @ 325MG;50MG N89568 001 - ADD - OCT 05,...
February Drug Approvals Drug Approvals for February 1997 Definitions and Notes February 1997 Original New Drug Applications Original Application #: 020723 Approval Date: 27-FEB-97 Trade Name: ALDARA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: 3M PHARMACEUTICALS INC Active Ingredient(s): IMIQUIMOD OTC/RX Status: RX Indication(s): Treatment of external genital and perianal warts...
DDPA June 1995 74-423 CAPTOPRIL MOVA CAPTOPRIL 07-JUN-95 (TABLET) CAGUAS, PR 12.5MG 00725 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-911 CLINORIL MERCK SULINDAC 01-JUN-95 (TABLET) WEST POINT, PA 150MG 19486 200MG (LABELING REVISION -- PRECAUTIONS; ADVERSE REACTIONS) 16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE 02-JUN-95 (TABLET) PALO...
DDPA February 1996 THERE ARE NO ORIGINAL ABBREVIATED AND 505(b)(2) NDAs WITH TENTATIVE APPROVALS FOR FEBRUARY 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-123 OMNIS CAN NYCOMED GADODIAMIDE 05-FEB-96 (INJECTABLE) WAYNE, PA 287MG/ML 19087 (LABELING REVISION -- INDICATIONS AND USAGE; DOSAGE AND ADMINISTRATION) 19-099 DOPAMINE HCL AND MCGAW DOPAMINE HYDROCHLORIDE 07-FEB-96 DEXTROSE 5% IRVINE, CA...
http://www.fda.gov/cder/foi/label/2001/20301S15lbl.pdf page 4
http://www.fda.gov/cder/foi/label/2001/20301S15lbl.pdf page 1
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...
Ortho-Cept PI page 3
author: Donna
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
http://www.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/Contraception/UTD-Oral.pdf page 4
author: floerchingerd [ M68498 ]
01-287 PhRMA NewMed WomenforPDF Johnson Pharmaceutical Research Institute Raritan, NJ Vioxx ® Merck Alzheimer's disease Phase IV rofecoxib Whitehouse Station, NJ (see also psychiatric) (800) 672- 6372 Zyprexa ® Eli Lilly Alzheimer's dementia Phase III olanzapine Indianapolis, IN (800) 545- 5979 O B S T E T R I C/ GY N E C O L O G I C C O N D I T I O N S Product Name Company Indication Development Status...
author: RL
FDA Drug Approvals List- March 1998 PEDIATRIC Dosage Form: INJECTABLE Applicant: ASTRA USA INC Active Ingredient(s): ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E OTC/RX Status: RX Application #: 050672 Labeling Supplement #: 012 To Original New Drug...
FDA Drug Approvals List August 1999 Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
