Details for New Drug Application (NDA): 078548
✉ Email this page to a colleague
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 078548
Tradename: | IMIQUIMOD |
Applicant: | Fougera Pharms |
Ingredient: | imiquimod |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078548
Mechanism of Action | Interferon Inducers |
Physiological Effect | Increased Cytokine Activity Increased Cytokine Production |
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: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
Approval Date: | Feb 25, 2010 | TE: | AB | RLD: | No |
Complete Access Available with Subscription