Last Updated: October 2, 2026

Details for New Drug Application (NDA): 078548

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NDA 078548 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 six 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. Nine suppliers are listed for this compound. Additional details are available on the imiquimod profile page.

Summary for 078548

Tradename:	IMIQUIMOD
Applicant:	Fougera Pharms
Ingredient:	imiquimod
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	5%
Approval Date:	Feb 25, 2010	TE:	AB	RLD:	No

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