← FDA Drug Approvals (Drugs@FDA)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZHEJIANG JIUZHOU BIOPHARMA CO., LTD. · Approved 2025-11-26
Drug application
- FDA Application #
ANDA217017
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
- Generic name
- Metformin Hydrochloride, Sitagliptin Phosphate
- Active ingredients
- METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- ZHEJIANG JIUZHOU BIOPHARMA CO., LTD.
- First approval
- 2025-11-26
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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