Application 204821
- Type
- ANDA
- Sponsor
- PRINSTON INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALSARTAN | VALSARTAN | TABLET;ORAL | 40MG | No | No |
| 002 | VALSARTAN | VALSARTAN | TABLET;ORAL | 80MG | No | No |
| 003 | VALSARTAN | VALSARTAN | TABLET;ORAL | 160MG | No | No |
| 004 | VALSARTAN | VALSARTAN | TABLET;ORAL | 320MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43547-367 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-367 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-367 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-368 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-368 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-368 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-369 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-369 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-369 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-370 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-370 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 43547-370 | Valsartan | valsartan | Solco Healthcare US, LLC | ANDA | Current |
| 50090-2424 | Valsartan | valsartan | A-S Medication Solutions | ANDA | Current |
| 50090-3108 | Valsartan | valsartan | A-S Medication Solutions | ANDA | Current |
| 55700-346 | Valsartan | valsartan | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-347 | Valsartan | valsartan | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 63187-655 | Valsartan | valsartan | Proficient Rx LP | ANDA | Current |
| 63187-655 | Valsartan | valsartan | Proficient Rx LP | ANDA | Current |
| 71335-0475 | Valsartan | valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0475 | Valsartan | valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0475 | Valsartan | valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0567 | Valsartan | valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0567 | Valsartan | valsartan | Bryant Ranch Prepack | ANDA | Current |