Application 215672
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREDNISONE | PREDNISONE | TABLET;ORAL | 2.5MG | No | No |
| 002 | PREDNISONE | PREDNISONE | TABLET;ORAL | 5MG | No | No |
| 003 | PREDNISONE | PREDNISONE | TABLET;ORAL | 10MG | No | No |
| 004 | PREDNISONE | PREDNISONE | TABLET;ORAL | 20MG | No | No |
| 005 | PREDNISONE | PREDNISONE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-485 | PREDNISONE | PREDNISONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-486 | PREDNISONE | PREDNISONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-487 | PREDNISONE | PREDNISONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-488 | PREDNISONE | PREDNISONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-489 | PREDNISONE | PREDNISONE | Aurobindo Pharma Limited | ANDA | Current |