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FDA ANDA · ANDA208535

METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE

Sponsor: ZYDUS PHARMS USA INC

APPLICATION
ANDA208535
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATENone (Tentative Approval)
METFORMIN HYDROCHLORIDE 50MG/500MG, SITAGLIPTIN PHOSPHATE 50MG/1000MG · TABLET · ORAL

Approval history

2026-06-30UNKNOWN · 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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