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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 078548

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NDA 078548 describes IMIQUIMOD, which is a drug marketed by Apotex Inc, Cosette, Encube, Fougera Pharms, Glenmark Pharms Inc, 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 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 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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