FdaApplication
ANDA 211563
Identifiers
- fda_app_no: ANDA211563
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2026-04-06 |
Products (4)
| 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;500MG | 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 |
4 products