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Generated: April 23, 2017

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Details for New Drug Application (NDA): 077623

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NDA 077623 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, Akorn, Teva Pharms, Tolmar, and Glenmark Generics, and is included in twenty-six NDAs. It is available from nineteen 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-one suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for NDA: 077623

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077623

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;TOPICAL 077623 ANDA Perrigo New York Inc 45802-141 45802-141-67 1 BOTTLE, WITH APPLICATOR in 1 CARTON (45802-141-67) > 6.6 mL in 1 BOTTLE, WITH APPLICATOR
SOLUTION;TOPICAL 077623 ANDA Preferred Pharmaceuticals, Inc. 68788-6797 68788-6797-6 1 BOTTLE, WITH APPLICATOR in 1 CARTON (68788-6797-6) > 6.6 mL in 1 BOTTLE, WITH APPLICATOR

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength8%
Approval Date:Sep 18, 2007TE:ATRLD:No

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