Application 205981
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 500MG;EQ 5MG BASE | No | No |
| 002 | SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 2.5MG BASE | No | No |
| 003 | SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 1GM;EQ 5MG BASE | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75167 | ORIG | 2023-08-21 |