Details for New Drug Application (NDA): 210232
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The generic ingredient in POMALIDOMIDE is pomalidomide. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the pomalidomide profile page.
Summary for 210232
| Tradename: | POMALIDOMIDE |
| Applicant: | Spil |
| Ingredient: | pomalidomide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210232
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210232 | ANDA | Sun Pharmaceutical Industries, Inc. | 70095-057 | 70095-057-01 | 21 CAPSULE in 1 BOTTLE (70095-057-01) |
| POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210232 | ANDA | Sun Pharmaceutical Industries, Inc. | 70095-057 | 70095-057-02 | 100 CAPSULE in 1 BOTTLE (70095-057-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MG | ||||
| Approval Date: | Aug 31, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | Aug 31, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 3MG | ||||
| Approval Date: | Aug 31, 2026 | TE: | AB | RLD: | No | ||||
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