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Last Updated: September 18, 2020

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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 Anda Repository, Apotex Inc, Cosette, Fougera Pharms, Glenmark Generics, Perrigo Israel, Strides Pharma, and Taro, and is included in eight NDAs. It is available from four 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. Six suppliers are listed for this compound. Additional details are available on the imiquimod profile page.
Summary for 078548
Applicant:Fougera Pharms
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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Serving leading biopharmaceutical companies globally:

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