Application 213273
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 2.5MG | No | No |
| 002 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 5MG | No | No |
| 003 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 10MG | No | No |
| 004 | ENALAPRIL MALEATE | ENALAPRIL MALEATE | TABLET;ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-545 | Enalapril Maleate | Enalapril Maleate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-546 | Enalapril Maleate | Enalapril Maleate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-547 | Enalapril Maleate | Enalapril Maleate | Solco Healthcare US, LLC | ANDA | Current |
| 43547-548 | Enalapril Maleate | Enalapril Maleate | Solco Healthcare US, LLC | ANDA | Current |
| 60760-575 | Enalapril Maleate | Enalapril Maleate | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 60760-688 | Enalapril Maleate | Enalapril Maleate | St Mary's Medical Park Pharmacy | ANDA | Current |
| 70518-3572 | Enalapril Maleate | Enalapril Maleate | REMEDYREPACK INC. | ANDA | Current |
| 71335-9604 | Enalapril Maleate | Enalapril Maleate | Bryant Ranch Prepack | ANDA | Current |