Drug Approvals - M Novartis Pharmaceuticals NDA 17-923/S049 & 11-808/S178 3/15/01 5/1/01 - - Mentax (Butenafine HCI) Cream, 1%,- Bertek Pharmaceuticals, IncMentax Indications:- for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum orbiculare)Mentax TC (Butenafine ...
http://www.fda.gov/cder/orange/appendix_a.txt PEDIATRIC, ASCORBIC ACID M.V.I.-12 LYOPHILIZED, ASCORBIC ACID M.V.I.-12, ASCORBIC ACID MACROBID, NITROFURANTOIN MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE MACROTEC, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT MAGNACORT, HYDROCORTAMATE HYDROCHLORIDE MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE...
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
Efficacy Supplements Approved in Calendar Year 2001 (SE1-SE7 AND SE8S) BUTENAFINE HCL BERTEK PHARMS 20-524 7-Aug-00 6-Jun-01 SE1 005 N 10.0 Provides for the use of Mentax (butenafine HCl cream) Cream, 1%, for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur (formerly Pityrosporum orbiculare)BUTENAFINE HYDROCHLORIDE SCHERING PLOUGH 21-307 29-Sep-00 7-Dec-01 N 000 N 14.3 Provides for the use...
author: Darlene Norris
Drug Approvals December 1996 Drug Approvals for December 1996 Definitions and Notes December 1996 Original New Drug Applications Original Application #: 020681 Approval Date: 31-DEC-96 Trade Name: ORTHO TRI-CYCLEN Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE...
Drug Approvals October 1996 Drug Approvals for October 1996 Definitions and Notes October 1996 Original New Drug Applications Original Application #: 019821 Approval Date: 28-OCT-96 Trade Name: SORIATANE Chemical Type: 2 Therapeutic Potential: S Dosage Form: CAPSULE Applicant: HOFFMAN-LAROCHE Active Ingredient(s): ACITRETIN OTC/RX Status: RX Indication(s): Treatment of severe psoriasis Original Application #:...
Drug Approvals for November 1997 Drug Approvals for November 1997 Definitions and Notes November 1997 Original New Drug Applications Original Application #: 020652 Approval Date: 26-NOV-97 Trade Name: TESLASCAN Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: NYCOMED INC Active Ingredient(s): MANGAFODIPIR TRISODIUM OTC/RX Status: RX Indication(s): As an adjunct to MRI to enhance the T1...
Ringworm: Fungal Skin Infections: Merck Manual Home Edition Topical Antifungal Drugs Amorolfine Butenafine Ciclopirox Clotrimazole Econazole Haloprogin Ketoconazole Miconazole Naftifine Nystatin ( Candida only) Oxiconazole Selenium sulfide (shampoo for tinea versicolor) Sulconazole Terbinafine Terconazole Tioconazole Tolnaftate Undecylenate Last reviewed/revised February 1, 2003 Back to Top Previous: Candidiasis Next: Tinea Versicolor...
Prescription antifungals for athlete's foot - [Medication] - Quest Diagnostics Patient Health Library In general: Butenafine is used for 1 to 2 weeks.
BioPortfolio Limited World Market for Anti-Infectives, Volume I - Antifungals Chapter One: Executive Summary Introduction Scope and Methodology Size and Growth of the Market Issues and Trends Affecting the Market Leading Competitors Chapter Two: Introduction Fungal Infections Superficial Systemic Histoplasmosis Coccidioidomycosis Blastomycosis Demographics and Statistics Chapter Three: Systemic...
20-524S005_Mentax.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Mentax (Butenafine HCI) Cream Company:--Bertek Pharmaceuticals Inc
author: Paul Stauffer
Document Information Page Tinea Corporis WEEK 2 (End of Treatment) WEEK 6 (4 Weeks Post- Treatment) Patient Outcome Category Butenafine Vehicle Butenafine Vehicle Mycological Cure 88% (37/ 42) 28% (10/ 36) 88% (37/ 42) 17% (6/ 36) Effective Treatment 60% (25/ 42) 17% ( 6/ 36) 81% (34/ 42) 14% (5/ 36) Overall Cure 31% (13/ 42) 3% ( 1/ 36) 67% (28/ 42) 14% (5/ 36) Tinea Cruris WEEK 2 (End of...
author: Revised by Frank Cross
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1996 and Older - New Drug Application (NDA) New Drug Approval Packages These drug approval packages, sorted by product trade name, are supplied by the CDER Freedom of Electronic Information Office
../2001/21-307_Lotrimin Cream Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Lotrimin Ultra (Butenafine Hydrochloride) Cream Company:--Schering-Plough HealthCare Products Application No.:--21-307 Approval Date:-12/7/2001 Approval Letter(s) - Printed Labeling - Medical Review(s) - Chemistry Review(s) - Pharmacology Review(s) - Statistical Review(s) -...
author: Paul Stauffer
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
DDPA April 1996 20-524 BUTENAFINE HCL PENEDERM BUTENAFINE HYDROCHLORIDE 03-APR-96 (CREAM) FOSTER CITY, CA 1% 94404 (ANTIFUNGAL) 20-511 APHTHASOL BLOCK DRUG AMLEXANOX 16-APR-96 (PASTE) JERSEY CITY, NJ 5% 07302 (ANTI-INFLAMMATORY) 19-764 SAIZEN SERONO LABS SOMATROPIN, BIOSYNTHETIC 22-APR-96 (INJECTABLE) NORWELL, MA 5MG/VIAL 02061 10MG/VIAL (HUMAN GROWTH HORMONE) 20-589 CHILDREN'S...
