Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218519
Company: FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,

Products on ANDA 218519

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
APIXABAN	APIXABAN	0.5MG	TABLET	None (Tentative Approval)	None	No	No
APIXABAN	APIXABAN	1.5MG	TABLET	None (Tentative Approval)	None	No	No
APIXABAN	APIXABAN	2.0MG	TABLET	None (Tentative Approval)	None	No	No
APIXABAN	APIXABAN	5MG	TABLET	None (Tentative Approval)	None	No	No
APIXABAN	APIXABAN	2.5MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218519

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/2025	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.