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Serving leading biopharmaceutical companies globally:

Novartis
US Army
Federal Trade Commission
Mallinckrodt
Moodys
US Department of Justice
McKinsey
Queensland Health
Fuji
Cerilliant

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078463

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NDA 078463 describes CICLOPIROX, which is a drug marketed by Fougera Pharms, G And W Labs Inc, Glenmark Pharms, Perrigo New York, Taro, Cnty Line Pharms, Glenmark Generics, Paddock Llc, Actavis Mid Atlantic, Perrigo Co, Akorn, Apotex Inc, Cipla Ltd, G And W Labs, Hi Tech Pharma, Mylan Pharms Inc, Taro Pharm Inds, Teva Pharms, and Tolmar, and is included in twenty-seven NDAs. It is available from nineteen 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 suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 078463
Tradename:CICLOPIROX
Applicant:G And W Labs Inc
Ingredient:ciclopirox
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078463
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CICLOPIROX ciclopirox CREAM;TOPICAL 078463 ANDA G&W Laboratories, Inc. 0713-0638 0713-0638-15 1 TUBE in 1 BOX (0713-0638-15) > 15 g in 1 TUBE
CICLOPIROX ciclopirox CREAM;TOPICAL 078463 ANDA G&W Laboratories, Inc. 0713-0638 0713-0638-31 1 TUBE in 1 BOX (0713-0638-31) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.77%
Approval Date:Dec 20, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
Julphar
Queensland Health
Mallinckrodt
AstraZeneca
Colorcon
Baxter
Farmers Insurance
Covington

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