← 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
JSON-LD · Markdown