Details for New Drug Application (NDA): 216213
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NDA 216213 describes LENALIDOMIDE, which is a drug marketed by Amneal, Apotex, Arrow Intl, Cipla, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Lotus Pharm Co Ltd, Mylan, Novugen, Qilu, Sun Pharm, Torrent, and Zydus Pharms, and is included in fifteen NDAs. It is available from thirteen suppliers. Additional details are available on the LENALIDOMIDE profile page.
The generic ingredient in LENALIDOMIDE is lenalidomide. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.
The generic ingredient in LENALIDOMIDE is lenalidomide. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 216213
| Tradename: | LENALIDOMIDE |
| Applicant: | Amneal |
| Ingredient: | lenalidomide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216213
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 216213 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1714 | 60219-1714-1 | 28 CAPSULE in 1 BOTTLE (60219-1714-1) |
| LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 216213 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1714 | 60219-1714-2 | 100 CAPSULE in 1 BOTTLE (60219-1714-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Jan 31, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 31, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 31, 2025 | TE: | AB | RLD: | No | ||||
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