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FDA ANDA · ANDA212322

EMPAGLIFLOZIN

Sponsor: AIZANT

APPLICATION
ANDA212322
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

EMPAGLIFLOZINNone (Tentative Approval)
EMPAGLIFLOZIN 10MG · TABLET · ORAL
EMPAGLIFLOZINNone (Tentative Approval)
EMPAGLIFLOZIN 25MG · TABLET · ORAL
EMPAGLIFLOZINNone (Tentative Approval)
EMPAGLIFLOZIN 2.5MG · TABLET · ORAL

Approval history

2020-12-29UNKNOWN · 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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