← FDA DRUG APPROVALS

FDA ANDA · ANDA212373

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA212373
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 12.5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 500MG · TABLET · ORAL
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 12.5MG, METFORMIN HYDROCHLORIDE 1000MG · TABLET · ORAL
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDENone (Tentative Approval)
EMPAGLIFLOZIN 5MG, METFORMIN HYDROCHLORIDE 1000MG · TABLET · ORAL

Approval history

2025-07-16UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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