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FDA ANDA · ANDA212374
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Sponsor: AUROBINDO PHARMA LIMITED
APPLICATION
ANDA212374
TYPE
ANDA
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 5MG/850MG · TABLET
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE 5MG/500MG · TABLET
Approval history
2026-06-11UNKNOWN · 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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