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Generated: October 17, 2018

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Details for New Drug Application (NDA): 078837

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NDA 078837 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 078837
Tradename:IMIQUIMOD
Applicant:Perrigo Israel
Ingredient:imiquimod
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078837
Suppliers and Packaging for NDA: 078837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIQUIMOD imiquimod CREAM;TOPICAL 078837 ANDA Perrigo New York Inc 45802-368 45802-368-53 12 PACKET in 1 CARTON (45802-368-53) > .25 g in 1 PACKET
IMIQUIMOD imiquimod CREAM;TOPICAL 078837 ANDA Perrigo New York Inc 45802-368 45802-368-62 24 PACKET in 1 CARTON (45802-368-62) > .25 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Sep 7, 2010TE:ABRLD:No

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