Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078079

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NDA 078079 describes CICLOPIROX, which is a drug marketed by Cosette Pharms Nc, Fougera Pharms, Glenmark Pharms, Padagis Israel, Sun Pharma Canada, Alvogen, 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 is one drug master file entry for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for 078079

Tradename:	CICLOPIROX
Applicant:	Teva Pharms
Ingredient:	ciclopirox
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	8%
Approval Date:	Sep 18, 2007	TE:		RLD:	No

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