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Last Updated: July 4, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078594

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NDA 078594 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. Seventeen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 078594
Applicant:Perrigo Co
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078594
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CICLOPIROX ciclopirox SHAMPOO;TOPICAL 078594 ANDA Perrigo New York Inc 45802-401 45802-401-09 1 BOTTLE in 1 CARTON (45802-401-09) > 120 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SHAMPOO;TOPICALStrength1%
Approval Date:Feb 16, 2010TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

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