Details for New Drug Application (NDA): 210249
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The generic ingredient in POMALIDOMIDE is pomalidomide. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the pomalidomide profile page.
Summary for 210249
| Tradename: | POMALIDOMIDE |
| Applicant: | Eugia Pharma |
| Ingredient: | pomalidomide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210249
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210249 | ANDA | Aurobindo Pharma Limited | 59651-194 | 59651-194-01 | 100 CAPSULE in 1 BOTTLE (59651-194-01) |
| POMALIDOMIDE | pomalidomide | CAPSULE;ORAL | 210249 | ANDA | Aurobindo Pharma Limited | 59651-194 | 59651-194-21 | 21 CAPSULE in 1 BOTTLE (59651-194-21) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MG | ||||
| Approval Date: | Oct 30, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
| Approval Date: | Oct 30, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 3MG | ||||
| Approval Date: | Oct 30, 2020 | TE: | AB | RLD: | No | ||||
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