Application 078508
- Type
- ANDA
- Sponsor
- EPIC PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRANDOLAPRIL | TRANDOLAPRIL | TABLET;ORAL | 2MG | No | No |
| 002 | TRANDOLAPRIL | TRANDOLAPRIL | TABLET;ORAL | 4MG | No | No |
| 003 | TRANDOLAPRIL | TRANDOLAPRIL | TABLET;ORAL | 1MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 42806-052 | Trandolapril | Trandolapril Tablets | Epic Pharma, LLC | ANDA | Current |
| 42806-053 | Trandolapril | Trandolapril Tablets | Epic Pharma, LLC | ANDA | Current |
| 42806-054 | Trandolapril | Trandolapril Tablets | Epic Pharma, LLC | ANDA | Current |
| 60429-978 | Trandolapril | Trandolapril Tablets | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-979 | Trandolapril | Trandolapril Tablets | Golden State Medical Supply Inc. | ANDA | Current |
| 60429-980 | Trandolapril | Trandolapril Tablets | Golden State Medical Supply Inc. | ANDA | Current |