Last Updated: May 31, 2026

Details for New Drug Application (NDA): 020723

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NDA 020723 describes ALDARA, which is a drug marketed by Bausch and is included in one NDA. Additional details are available on the ALDARA profile page.

The generic ingredient in ALDARA is imiquimod. There are fourteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

Summary for 020723

Tradename:	ALDARA
Applicant:	Bausch
Ingredient:	imiquimod
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 27, 1997	TE:		RLD:	Yes

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