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Last Updated: January 21, 2020

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Details for New Drug Application (NDA): 090146

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NDA 090146 describes CICLOPIROX, which is a drug marketed by Acp Nimble, Fougera Pharms, Glenmark Pharms, Perrigo Israel, Taro, Cnty Line Pharms, Glenmark Generics, Paddock Llc, Actavis Mid Atlantic, Perrigo Co, Teligent Pharma Inc, Acella, Akorn, Anda Repository, Hi Tech Pharma, Mylan Pharms Inc, Novast Labs, Perrigo New York, Taro Pharm Inds, and Teva Pharms, and is included in twenty-eight NDAs. It is available from fourteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 090146
Tradename:CICLOPIROX
Applicant:Fougera Pharms
Ingredient:ciclopirox
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength1%
Approval Date:May 25, 2010TE:ATRLD:No

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