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FDA ANDA · ANDA220511
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Sponsor: AJANTA PHARMA LTD
APPLICATION
ANDA220511
TYPE
ANDA
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 25MG/1000MG · TABLET, EXTENDED RELEASE
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 10MG/1000MG · TABLET, EXTENDED RELEASE
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 12.5MG/1000MG · TABLET, EXTENDED RELEASE
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 5MG/1000MG · TABLET, EXTENDED RELEASE
Approval history
2026-02-25UNKNOWN · Original · standardTA
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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