Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021159

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NDA 021159 describes LOPROX, which is a drug marketed by Eurofarma and Bausch and is included in three NDAs. Additional details are available on the LOPROX profile page.

The generic ingredient in LOPROX 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 021159

Tradename:	LOPROX
Applicant:	Bausch
Ingredient:	ciclopirox
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SHAMPOO;TOPICAL			Strength	1%
Approval Date:	Feb 28, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021159

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	⤷ Start Trial	⤷ Start Trial
Bausch	LOPROX	ciclopirox	SHAMPOO;TOPICAL	021159-001	Feb 28, 2003	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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