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Details for New Drug Application (NDA): 077092

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NDA 077092 describes CICLOPIROX, which is a drug marketed by Fougera Pharms, Perrigo New York, Cipla Ltd, G And W Labs, Taro Pharm Inds, Actavis Mid Atlantic, G And W Labs Inc, Perrigo, Paddock Llc, Mylan Pharms Inc, Taro, Hi Tech Pharma, Apotex Inc, Glenmark Pharms, Versapharm, Teva Pharms, Tolmar, and Glenmark Generics, and is included in twenty-six NDAs. It is available from eighteen suppliers. Additional details are available on the CICLOPIROX profile page.

The generic ingredient in CICLOPIROX is ciclopirox. There are ten drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for NDA: 077092

Therapeutic Class:Antifungals

Suppliers and Packaging for NDA: 077092

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUSPENSION;TOPICAL 077092 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1323 51672-1323-3 1 BOTTLE in 1 CARTON (51672-1323-3) > 30 mL in 1 BOTTLE
SUSPENSION;TOPICAL 077092 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1323 51672-1323-4 1 BOTTLE in 1 CARTON (51672-1323-4) > 60 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;TOPICALStrength0.77%
Approval Date:Aug 10, 2005TE:ABRLD:No

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