Details for New Drug Application (NDA): 021022

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NDA 021022 describes PENLAC, which is a drug marketed by Valeant Bermuda and is included in one NDA. Additional details are available on the PENLAC profile page.

The generic ingredient in PENLAC is ciclopirox. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for 021022

Tradename:	PENLAC
Applicant:	Valeant Bermuda
Ingredient:	ciclopirox
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	8% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 17, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 021022

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Bermuda	PENLAC	ciclopirox	SOLUTION;TOPICAL	021022-001	Dec 17, 1999	4,957,730	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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