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FDA ANDA · ANDA212198
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Sponsor: ZYDUS PHARMS
APPLICATION
ANDA212198
TYPE
ANDA
ORIGINAL APPROVAL
2022-07-07
LATEST ACTION
2024-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDiscontinued
EMPAGLIFLOZIN 12.5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDiscontinued
EMPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 1GM · TABLET · ORAL
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDiscontinued
EMPAGLIFLOZIN 12.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDiscontinued
EMPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
Approval history
2024-08-13Labeling · Supplement 4 · standardAP
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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