Details for New Drug Application (NDA): 078837
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NDA 078837 describes IMIQUIMOD, which is a drug marketed by Apotex Inc, Cosette, Encube, Fougera Pharms, Glenmark Pharms Inc, Padagis Israel, Strides Pharma, and Taro, and is included in nine NDAs. It is available from five 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.
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: | Padagis Israel |
| Ingredient: | imiquimod |
| Patents: | 0 |
Pharmacology for NDA: 078837
| Mechanism of Action | Interferon Inducers |
| Physiological Effect | Increased Cytokine Activity Increased Cytokine Production |
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 | Padagis Israel Pharmaceuticals Ltd | 45802-368 | 45802-368-53 | 12 PACKET in 1 CARTON (45802-368-53) / .25 g in 1 PACKET |
| IMIQUIMOD | imiquimod | CREAM;TOPICAL | 078837 | ANDA | Padagis Israel Pharmaceuticals Ltd | 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: | RX | Dosage: | CREAM;TOPICAL | Strength | 5% | ||||
| Approval Date: | Sep 7, 2010 | TE: | AB | RLD: | No | ||||
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