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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078975

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NDA 078975 describes CICLOPIROX, which is a drug marketed by Cosette, Fougera Pharms, Glenmark Pharms, Padagis Israel, Taro, Alvogen, Glenmark Pharms Inc, 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 fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for 078975

Tradename:	CICLOPIROX
Applicant:	Epic Pharma Llc
Ingredient:	ciclopirox
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	8%
Approval Date:	Feb 17, 2010	TE:		RLD:	No

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