FdaApplication
ANDA 076345
Identifiers
- fda_app_no: ANDA076345
Properties
| Property | Value |
|---|---|
| applicant_name | IMPAX LABORATORIES LLC |
| application_type | ANDA |
| approval_date | 2004-02-18 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET;ORAL |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 1.25MG;250MG | TABLET;ORAL |
| GLYBURIDE AND METFORMIN HYDROCHLORIDE | GLYBURIDE; METFORMIN HYDROCHLORIDE | 2.5MG;500MG | TABLET;ORAL |
3 products