← FDA DRUG APPROVALS

FDA ANDA · ANDA211563

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA211563
TYPE
ANDA
ORIGINAL APPROVAL
2026-04-06
LATEST ACTION
2026-04-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEPrescription
DAPAGLIFLOZIN 10MG, METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEPrescription
DAPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEPrescription
DAPAGLIFLOZIN 10MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEPrescription
DAPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2026-04-06UNKNOWN · Original · standard — Letter ↗AP
2026-04-06UNKNOWN · Original · standard — Label ↗TA
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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