Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219687
Company: MYLAN PHARMACEUTICALS INC

Products on ANDA 219687

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFAXIMIN	RIFAXIMIN	550MG	TABLET	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219687

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2026	ORIG-1	Tentative Approval		STANDARD		Label is not available on this site.