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FDA ANDA · ANDA217017
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sponsor: ZHEJIANG JIUZHOU BIOPHARMA CO., LTD.
APPLICATION
ANDA217017
TYPE
ANDA
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
SITAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE 50MG · TABLET, EXTENDED RELEASE
SITAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE 100MG · TABLET, EXTENDED RELEASE
SITAGLIPTIN AND METFORMIN HYDROCHLORIDENone (Tentative Approval)
METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE 500MG · TABLET, EXTENDED RELEASE
Approval history
2025-11-26UNKNOWN · Original · standardTA
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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