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FDA ANDA · ANDA214494

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Sponsor: APOTEX INC

APPLICATION
ANDA214494
TYPE
ANDA
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

SITAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE, SITAGLIPTIN 50MG · TABLET, EXTENDED RELEASE
SITAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE, SITAGLIPTIN 500MG · TABLET, EXTENDED RELEASE
SITAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE, SITAGLIPTIN 100MG · TABLET, EXTENDED RELEASE

Approval history

2026-03-10UNKNOWN · 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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