Application 216778
- Type
- NDA
- Sponsor
- ZYDUS LIFESCIENCES
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 500MG;50MG | Yes | No |
| 002 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 1GM;50MG | Yes | No |
| 003 | ZITUVIMET XR | METFORMIN HYDROCHLORIDE; SITAGLIPTIN | TABLET, EXTENDED RELEASE;ORAL | 1GM;100MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82214 | ORIG | 2025-05-21 |
| 82198 | ORIG | 2025-05-19 |
| 79142 | ORIG | 2024-07-22 |
| 79141 | ORIG | 2024-07-22 |