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Details for New Drug Application (NDA): 078548

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NDA 078548 describes IMIQUIMOD, which is a drug marketed by Strides Pharma, Apotex Inc, Perrigo Israel, Tolmar, Fougera Pharms, Taro, G And W Labs Inc, and Glenmark Generics, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the IMIQUIMOD profile page.

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

Summary for NDA: 078548

Fougera Pharms
Therapeutic Class:Dermatological Agents

Pharmacology for NDA: 078548

Suppliers and Packaging for NDA: 078548

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
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

Summary for product number 001

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

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