Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208549
Company: PRINSTON INC

Products on ANDA 208549

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIVAROXABAN	RIVAROXABAN	10MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
RIVAROXABAN	RIVAROXABAN	15MG	TABLET;ORAL	None (Tentative Approval)	None	No	No
RIVAROXABAN	RIVAROXABAN	20MG	TABLET;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208549

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/06/2024	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.