FdaApplication
ANDA 211583
Identifiers
- fda_app_no: ANDA211583
Properties
| Property | Value |
|---|---|
| applicant_name | TEVA PHARMACEUTICALS USA INC |
| application_type | ANDA |
| approval_date | 2026-04-06 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 10MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 5MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 10MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE | 2.5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
5 products