Application 202187
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SPIRONOLACTONE | SPIRONOLACTONE | TABLET;ORAL | 25MG | No | No |
| 002 | SPIRONOLACTONE | SPIRONOLACTONE | TABLET;ORAL | 50MG | No | No |
| 003 | SPIRONOLACTONE | SPIRONOLACTONE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-426 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-426 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-426 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-426 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-427 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-427 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-427 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-427 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-428 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-428 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-428 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |
| 59651-428 | SPIRONOLACTONE | SPIRONOLACTONE | Aurobindo Pharma Limited | ANDA | Current |