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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075319

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NDA 075319 describes KETOCONAZOLE, which is a drug marketed by Perrigo Israel, Fougera Pharms, Teva, Perrigo New York, Tolmar, Aaipharma Llc, Apotex, Mylan, Pliva, Sun Pharm Industries, and Taro, and is included in thirteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the KETOCONAZOLE profile page.

The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.
Summary for 075319
Tradename:KETOCONAZOLE
Applicant:Taro
Ingredient:ketoconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 075319
Medical Subject Heading (MeSH) Categories for 075319
Suppliers and Packaging for NDA: 075319
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE ketoconazole TABLET;ORAL 075319 ANDA Rebel Distributors Corp 21695-562 E 21695-562-30
KETOCONAZOLE ketoconazole TABLET;ORAL 075319 ANDA Aidarex Pharmaceuticals LLC 33261-739 N 33261-739-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jun 15, 1999TE:ABRLD:No

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