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FDA ANDA · ANDA216288

SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Sponsor: MSN LABORATORIES PRIVATE LTD

APPLICATION
ANDA216288
TYPE
ANDA
DOSAGE FORM
TABLET, COATED
MARKETING STATUS
None (Tentative Approval)

Products

SITAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE, SITAGLIPTIN 500MG · TABLET, COATED
SITAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE, SITAGLIPTIN 50MG · TABLET, COATED

Approval history

2025-07-14UNKNOWN · Original · standardTA
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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