Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022554
Company: SALIX PHARMS

• Latest label for Xifaxan (original NDA 021361)

• In Use Labeling as of 11/9/2022

• Summary Review

Products on NDA 022554

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XIFAXAN	RIFAXIMIN	550MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022554

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/24/2010	ORIG-1	Approval	Type 6 - New Indication (no longer used)	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022554s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022554_xifaxan_toc_.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022554Orig1s000SumR.pdf

Labels for NDA 022554

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf