Application 210154
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 2.5MG | No | No |
| 002 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 5MG | No | No |
| 003 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 10MG | No | No |
| 004 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 15MG | No | No |
| 005 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 20MG | No | No |
| 006 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 25MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 70710-1031 | LENALIDOMIDE | LENALIDOMIDE | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1032 | LENALIDOMIDE | LENALIDOMIDE | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1033 | LENALIDOMIDE | LENALIDOMIDE | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70710-1035 | LENALIDOMIDE | LENALIDOMIDE | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 70771-1677 | LENALIDOMIDE | LENALIDOMIDE | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1678 | LENALIDOMIDE | LENALIDOMIDE | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1679 | LENALIDOMIDE | LENALIDOMIDE | Zydus Lifesciences Limited | ANDA | Current |
| 70771-1681 | LENALIDOMIDE | LENALIDOMIDE | Zydus Lifesciences Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76345 | ORIG | 2023-11-06 |
| 72075 | ORIG | 2022-09-13 |