Last Updated: September 25, 2026

Details for New Drug Application (NDA): 200481

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NDA 200481 describes IMIQUIMOD, which is a drug marketed by Apotex Inc, Cosette Pharms Nc, Encube, Fougera Pharms, Glenmark Pharms, Padagis Israel, Strides Pharma, and Taro, and is included in nine NDAs. It is available from five suppliers. Additional details are available on the IMIQUIMOD profile page.

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

Summary for 200481

Tradename:	IMIQUIMOD
Applicant:	Cosette Pharms Nc
Ingredient:	imiquimod
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Apr 18, 2011	TE:		RLD:	No

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