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Serving leading biopharmaceutical companies globally:

US Army
Argus Health
Queensland Health
Federal Trade Commission

Generated: November 21, 2017

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Details for New Drug Application (NDA): 078233

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NDA 078233 describes CICLOPIROX, which is a drug marketed by Cnty Line Pharms, Fougera Pharms, Perrigo New York, Cipla Ltd, G And W Labs, Taro Pharm Inds, Actavis Mid Atlantic, G And W Labs Inc, Paddock Llc, Mylan Pharms Inc, Taro, Hi Tech Pharma, Apotex Inc, Glenmark Pharms, Akorn, Teva Pharms, Tolmar, Perrigo Co, and Glenmark Generics, and is included in twenty-seven NDAs. It is available from twenty suppliers. There are two patents protecting this drug. 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 078233

Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 078233

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;TOPICAL 078233 ANDA G&W Laboratories, Inc. 0713-0317 0713-0317-87 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0713-0317-87) > 3.3 mL in 1 BOTTLE, WITH APPLICATOR
SOLUTION;TOPICAL 078233 ANDA G&W Laboratories, Inc. 0713-0317 0713-0317-88 1 BOTTLE, WITH APPLICATOR in 1 CARTON (0713-0317-88) > 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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Serving leading biopharmaceutical companies globally:

Queensland Health
US Army
Argus Health
Daiichi Sankyo
Harvard Business School
Farmers Insurance
US Department of Justice

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