Details for New Drug Application (NDA): 213885
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NDA 213885 describes LENALIDOMIDE, which is a drug marketed by 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 fourteen NDAs. It is available from twelve 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the lenalidomide profile page.
Summary for 213885
| Tradename: | LENALIDOMIDE |
| Applicant: | Eugia Pharma |
| Ingredient: | lenalidomide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213885
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 213885 | ANDA | Aurobindo Pharma Limited | 59651-342 | 59651-342-01 | 100 CAPSULE in 1 BOTTLE (59651-342-01) |
| LENALIDOMIDE | lenalidomide | CAPSULE;ORAL | 213885 | ANDA | Aurobindo Pharma Limited | 59651-342 | 59651-342-07 | 1 BLISTER PACK in 1 CARTON (59651-342-07) / 7 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Mar 6, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 6, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 6, 2023 | TE: | AB | RLD: | No | ||||
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