Application 202696
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-062 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-062 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-062 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-062 | Valsartan | Valsartan | Macleods Pharmaceuticals | ANDA | Current |
| 33342-062 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-062 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-062 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-063 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-063 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-063 | Valsartan | Valsartan | Macleods Pharmaceuticals | ANDA | Current |
| 33342-063 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-063 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-063 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-063 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-064 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-064 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-064 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-064 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-064 | Valsartan | Valsartan | Macleods Pharmaceuticals | ANDA | Current |
| 33342-064 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-064 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-065 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-065 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-065 | Valsartan | Valsartan | Macleods Pharmaceuticals | ANDA | Current |
| 33342-065 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-065 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-065 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-065 | Valsartan | Valsartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 50090-4130 | Valsartan | Valsartan | A-S Medication Solutions | ANDA | Current |
| 50090-4130 | Valsartan | Valsartan | A-S Medication Solutions | ANDA | Current |
| 50090-4130 | Valsartan | Valsartan | A-S Medication Solutions | ANDA | Current |
| 50090-4130 | Valsartan | Valsartan | A-S Medication Solutions | ANDA | Current |
| 50090-4824 | Valsartan | Valsartan | A-S Medication Solutions | ANDA | Current |
| 50090-4824 | Valsartan | Valsartan | A-S Medication Solutions | ANDA | Current |
| 50090-4837 | Valsartan | Valsartan | A-S Medication Solutions | ANDA | Current |
| 50090-4837 | Valsartan | Valsartan | A-S Medication Solutions | ANDA | Current |
| 63629-7432 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 63629-7432 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 63629-7432 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 70518-1279 | Valsartan | Valsartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-1279 | Valsartan | Valsartan | REMEDYREPACK INC. | ANDA | Current |
| 71205-301 | Valsartan | Valsartan | Proficient Rx LP | ANDA | Current |
| 71205-301 | Valsartan | Valsartan | Proficient Rx LP | ANDA | Current |
| 71205-301 | Valsartan | Valsartan | Proficient Rx LP | ANDA | Current |
| 71335-0097 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0097 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0097 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0097 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0488 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0488 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0488 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-0555 | Valsartan | Valsartan | Bryant Ranch Prepack | ANDA | Current |
| 72189-049 | VALSARTAN | VALSARTAN | Direct_Rx | ANDA | Current |
| 72189-049 | VALSARTAN | VALSARTAN | Direct_Rx | ANDA | Current |
| 72189-049 | VALSARTAN | VALSARTAN | Direct_Rx | ANDA | Current |