Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021361
Company: SALIX PHARMS
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 |