Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208959
Company: ACTAVIS LABS FL INC

Products on ANDA 208959

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFAXIMIN	RIFAXIMIN	550MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208959

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/19/2026	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208959Orig1s000Panoramaltr.pdf

Therapeutic Equivalents for ANDA 208959

RIFAXIMIN

TABLET;ORAL; 550MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RIFAXIMIN	RIFAXIMIN	550MG	TABLET;ORAL	Prescription	No	AB	208959	ACTAVIS LABS FL INC
XIFAXAN	RIFAXIMIN	550MG	TABLET;ORAL	Prescription	Yes	AB	021361	SALIX PHARMS