Application 213912
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 5MG | No | No |
| 002 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 10MG | No | No |
| 003 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 15MG | No | No |
| 004 | LENALIDOMIDE | LENALIDOMIDE | CAPSULE;ORAL | 25MG | 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1936 | Lenalidomide | Lenalidomide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1937 | Lenalidomide | Lenalidomide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1940 | Lenalidomide | Lenalidomide | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1941 | Lenalidomide | Lenalidomide | Mylan Pharmaceuticals Inc. | ANDA | Current |