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FDA NDA · NDA211566

SITAGLIPTIN

Sponsor: ZYDUS LIFESCIENCES

APPLICATION
NDA211566
TYPE
NDA
ORIGINAL APPROVAL
2023-10-18
LATEST ACTION
2023-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZITUVIO · ReferencePrescription
SITAGLIPTIN 100MG · TABLET · ORAL
ZITUVIO · ReferencePrescription
SITAGLIPTIN 25MG · TABLET · ORAL
ZITUVIO · ReferencePrescription
SITAGLIPTIN 50MG · TABLET · ORAL

Approval history

2023-10-18Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
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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