Details for New Drug Application (NDA): 213912
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NDA 213912 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 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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