← FDA DRUG APPROVALS

FDA NDA · NDA021361

XIFAXAN

rifaximin

Sponsor: SALIX PHARMS

APPLICATION
NDA021361
TYPE
NDA
ORIGINAL APPROVAL
2004-05-25
LATEST ACTION
2023-10-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XIFAXAN · ReferencePrescription
RIFAXIMIN 550MG · TABLET · ORAL
XIFAXAN · ReferencePrescription
RIFAXIMIN 200MG · TABLET · ORAL

Approval history

2023-10-19Labeling · Supplement 31 · standard — Letter ↗AP
2022-10-19Labeling · Supplement 29 · standard — Letter ↗AP
2020-11-06Labeling · Supplement 25 · standard — Letter ↗AP
2017-12-18Labeling · Supplement 23 · standard — Label ↗AP
2017-01-06Manufacturing (CMC) · Supplement 17 · standardAP
2016-06-16Manufacturing (CMC) · Supplement 15 · standardAP
2015-10-15Manufacturing (CMC) · Supplement 16 · standardAP
2015-05-27Efficacy · Supplement 12 · priority — Label ↗AP
2015-04-23Manufacturing (CMC) · Supplement 14 · standardAP
2014-03-12Labeling · Supplement 13 · standard — Letter ↗AP
2010-11-15Labeling · Supplement 9 · standard — Letter ↗AP
2010-03-03Labeling · Supplement 11 · unknown — Letter ↗AP
2007-01-30Labeling · Supplement 6 · standard — Label ↗AP
2004-05-25Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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