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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Chinese Patent Office
Daiichi Sankyo
Argus Health

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091308

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NDA 091308 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 091308
Applicant:Apotex Inc
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091308
Suppliers and Packaging for NDA: 091308
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMIQUIMOD imiquimod CREAM;TOPICAL 091308 ANDA Apotex Corp. 60505-0501 60505-0501-4 12 PACKET in 1 CARTON (60505-0501-4) > 250 mg in 1 PACKET
IMIQUIMOD imiquimod CREAM;TOPICAL 091308 ANDA Apotex Corp. 60505-0501 60505-0501-5 24 PACKET in 1 CARTON (60505-0501-5) > 250 mg in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Apr 6, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
Fish and Richardson
Queensland Health

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