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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021361
Company: SALIX PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XIFAXAN RIFAXIMIN 200MG TABLET;ORAL Prescription None Yes Yes
XIFAXAN RIFAXIMIN 550MG TABLET;ORAL Prescription None Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
10/19/2023 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021361s031lbl.pdf
10/19/2022 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021361s029lbl.pdf
11/06/2020 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021361s025lbl.pdf
12/18/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021361s023lbl.pdf
05/27/2015 SUPPL-12 Efficacy-New Indication Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbledt.pdf
03/12/2014 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021361s013lbl.pdf
11/15/2010 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s009lbl.pdf
03/03/2010 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s011lbl.pdf
01/30/2007 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021361s006lbl.pdf
05/25/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21361_xifaxan_lbl.pdf
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