Application 216743
- Type
- NDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZITUVIMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET;ORAL | 500MG;50MG | Yes | No |
| 002 | ZITUVIMET | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET;ORAL | 1GM;50MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85776 | SUPPL | 2026-04-28 |
| 85767 | SUPPL | 2026-04-27 |
| 78973 | ORIG | 2024-07-03 |
| 76382 | ORIG | 2023-11-06 |
| 76381 | ORIG | 2023-11-06 |
| 76373 | ORIG | 2023-11-06 |