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Generated: September 21, 2018

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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 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 six 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
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)

Profile for product number 001

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

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