Application 202254
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 75MG | No | No |
| 002 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 150MG | No | No |
| 003 | IRBESARTAN | IRBESARTAN | TABLET;ORAL | 300MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-047 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-047 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-047 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-047 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-048 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-048 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-048 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-048 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-049 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-049 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-049 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-049 | Irbesartan | Irbesartan | Macleods Pharmaceuticals Limited | ANDA | Current |
| 50436-4652 | Irbesartan | Irbesartan | Unit Dose Services | ANDA | Current |
| 61919-793 | IRBESARTAN | IRBESARTAN | DIRECTRX | ANDA | Current |
| 63187-737 | Irbesartan | Irbesartan | Proficient Rx LP | ANDA | Current |
| 63187-737 | Irbesartan | Irbesartan | Proficient Rx LP | ANDA | Current |
| 63187-737 | Irbesartan | Irbesartan | Proficient Rx LP | ANDA | Current |
| 63629-5241 | Irbesartan | Irbesartan | Bryant Ranch Prepack | ANDA | Current |
| 63629-5241 | Irbesartan | Irbesartan | Bryant Ranch Prepack | ANDA | Current |
| 63629-5241 | Irbesartan | Irbesartan | Bryant Ranch Prepack | ANDA | Current |
| 63629-8259 | Irbesartan | Irbesartan | Bryant Ranch Prepack | ANDA | Current |
| 63629-8259 | Irbesartan | Irbesartan | Bryant Ranch Prepack | ANDA | Current |
| 70518-1328 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-1328 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-1328 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-1328 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-1328 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-1329 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-1329 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2155 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2205 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2205 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2205 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2205 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2211 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2211 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2211 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 70518-2211 | Irbesartan | Irbesartan | REMEDYREPACK INC. | ANDA | Current |
| 71205-379 | Irbesartan | Irbesartan | Proficient Rx LP | ANDA | Current |
| 71205-379 | Irbesartan | Irbesartan | Proficient Rx LP | ANDA | Current |
| 71335-1263 | Irbesartan | Irbesartan | Bryant Ranch Prepack | ANDA | Current |
| 71335-1263 | Irbesartan | Irbesartan | Bryant Ranch Prepack | ANDA | Current |