Application 077507
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;250MG | No | No |
| 002 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 2.5MG;500MG | No | No |
| 003 | GLIPIZIDE AND METFORMIN HYDROCHLORIDE | GLIPIZIDE; METFORMIN HYDROCHLORIDE | TABLET;ORAL | 5MG;500MG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9055 | ORIG | 2005-11-01 |