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Serving leading biopharmaceutical companies globally:

Queensland Health
Chinese Patent Office
Daiichi Sankyo
Harvard Business School
Federal Trade Commission
Farmers Insurance

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078548

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NDA 078548 describes IMIQUIMOD, which is a drug marketed by Apotex Inc, Fougera Pharms, G And W Labs Inc, Glenmark Generics, Perrigo Israel, Strides Pharma, Taro, and Tolmar, and is included in eight NDAs. It is available from eight 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. Nine suppliers are listed for this compound. Additional details are available on the imiquimod profile page.
Summary for 078548
Applicant:Fougera Pharms
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078548
Suppliers and Packaging for NDA: 078548
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIQUIMOD imiquimod CREAM;TOPICAL 078548 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0432 0168-0432-24 24 PACKET in 1 BOX (0168-0432-24) > .25 g in 1 PACKET (0168-0432-27)
IMIQUIMOD imiquimod CREAM;TOPICAL 078548 ANDA Physicians Total Care, Inc. 54868-6179 54868-6179-0 24 PACKET in 1 CARTON (54868-6179-0) > 1 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Feb 25, 2010TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Express Scripts

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