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FDA ANDA · ANDA212362

EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE

Sponsor: MSN LABS PVT LTD

APPLICATION
ANDA212362
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

EMPAGLIFLOZIN METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 12.5MG/1000MG, METFORMIN HYDROCHLORIDE · TABLET, EXTENDED RELEASE · ORAL
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 5MG/1000MG, METFORMIN HYDROCHLORIDE · TABLET, EXTENDED RELEASE · ORAL
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 25MG/1000MG, METFORMIN HYDROCHLORIDE · TABLET, EXTENDED RELEASE · ORAL
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 10MG/1000MG, METFORMIN HYDROCHLORIDE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-01-31UNKNOWN · Original · standardLetterTA
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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