← FDA DRUG APPROVALS

FDA NDA · NDA216743

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Sponsor: ZYDUS LIFESCIENCES

APPLICATION
NDA216743
TYPE
NDA
ORIGINAL APPROVAL
2023-11-03
LATEST ACTION
2025-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ZITUVIMET · ReferencePrescription
METFORMIN HYDROCHLORIDE 500MG, SITAGLIPTIN 50MG · TABLET · ORAL
ZITUVIMET · ReferencePrescription
METFORMIN HYDROCHLORIDE 1GM, SITAGLIPTIN 50MG · TABLET · ORAL

Approval history

2025-05-29Manufacturing (CMC) · Supplement 5 — Label ↗AP
2023-11-03Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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