Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 219296
Company: FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,

Products on ANDA 219296

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	1000MG ER TABLET	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	EQ 100MG BASE TABLET	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	500MG	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	50MG	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	1000MG	TABLET, EXTENDED RELEASE	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219296

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/12/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.