Details for New Drug Application (NDA): 213912
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The generic ingredient in LENALIDOMIDE is lenalidomide. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 213912
| Tradename: | LENALIDOMIDE |
| Applicant: | Mylan |
| Ingredient: | lenalidomide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213912
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 213912 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1935 | 0378-1935-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-01) |
| LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 213912 | ANDA | Mylan Pharmaceuticals Inc. | 0378-1935 | 0378-1935-28 | 28 CAPSULE in 1 BOTTLE, PLASTIC (0378-1935-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 30, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 30, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
| Approval Date: | Aug 30, 2022 | TE: | AB | RLD: | No | ||||
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