Last Updated: November 8, 2026

Details for New Drug Application (NDA): 076422

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NDA 076422 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 076422

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;TOPICAL			Strength	0.77%
Approval Date:	Aug 6, 2004	TE:	AB	RLD:	No

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