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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077092


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NDA 077092 describes CICLOPIROX, which is a drug marketed by Cosette, Fougera Pharms, Glenmark Pharms, Padagis Israel, Taro, Alvogen, Glenmark Generics, Padagis Us, Actavis Mid Atlantic, Encube, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, Rising, 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. Fifteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 077092
Tradename:CICLOPIROX
Applicant:Taro
Ingredient:ciclopirox
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077092
Suppliers and Packaging for NDA: 077092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CICLOPIROX ciclopirox SUSPENSION;TOPICAL 077092 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1323 51672-1323-3 1 BOTTLE in 1 CARTON (51672-1323-3) / 30 mL in 1 BOTTLE
CICLOPIROX ciclopirox SUSPENSION;TOPICAL 077092 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-1323 51672-1323-4 1 BOTTLE in 1 CARTON (51672-1323-4) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;TOPICALStrength0.77%
Approval Date:Aug 10, 2005TE:ABRLD:No

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