Application 208430
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;500MG | No | No |
| 002 | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;850MG | No | No |
| 003 | LINAGLIPTIN; METFORMIN HYDROCHLORIDE | LINAGLIPTIN;METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;1GM | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 56852 | ORIG | 2018-12-20 |