Details for New Drug Application (NDA): 201994
NDA 201994 describes IMIQUIMOD, which is a drug marketed by Apotex Inc, Cosette Pharms Nc, Encube, Fougera Pharms, Glenmark Pharms, Padagis Israel, Strides Pharma, and Taro, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the IMIQUIMOD profile page.
The generic ingredient in IMIQUIMOD is imiquimod. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the imiquimod profile page.
The generic ingredient in IMIQUIMOD is imiquimod. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the imiquimod profile page.
Summary for 201994
| Tradename: | IMIQUIMOD |
| Applicant: | Glenmark Pharms |
| Ingredient: | imiquimod |
| Patents: | 0 |
Pharmacology for NDA: 201994
| Mechanism of Action | Interferon Inducers |
| Physiological Effect | Increased Cytokine Activity Increased Cytokine Production |
Suppliers and Packaging for NDA: 201994
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMIQUIMOD | imiquimod | CREAM;TOPICAL | 201994 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-536 | 68462-536-70 | 24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Mar 6, 2012 | TE: | AB | RLD: | No | ||||
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