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Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 021361

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021361

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21361_xifaxan_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21361ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-361_Xifaxan.cfm

Supplements

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) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021361s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021361Orig1s031ltr.pdf
10/19/2022	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021361s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021361Orig1s029ltr.pdf
11/06/2020	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021361s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021361Orig1s025ltr.pdf
12/18/2017	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021361s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021361Orig1s023ltr.pdf
01/06/2017	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/15/2015	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/16/2016	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
04/23/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
03/12/2014	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021361s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021361Orig1s013ltr.pdf
05/27/2015	SUPPL-12	Efficacy-New Indication	Label (PDF) Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021361Orig1s012ltr.pdf
03/03/2010	SUPPL-11	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021361s011ltr.pdf
11/15/2010	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021361s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021361s009ltr.pdf
01/30/2007	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021361s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021361s006ltr.pdf

Labels for NDA 021361

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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