Application 219423
- Type
- NDA
- Sponsor
- AZURITY
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WIDAPLIK | AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN | TABLET;ORAL | EQ 1.25MG BASE;0.625MG;10MG | Yes | No |
| 002 | WIDAPLIK | AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN | TABLET;ORAL | EQ 2.5MG BASE;1.25MG;20MG | Yes | No |
| 003 | WIDAPLIK | AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN | TABLET;ORAL | EQ 5MG BASE;2.5MG;40MG | Yes | Yes |