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FDA NDA · NDA021024

PRIFTIN

rifapentine

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA021024
TYPE
NDA
ORIGINAL APPROVAL
1998-06-22
LATEST ACTION
2026-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PRIFTIN · ReferencePrescription
RIFAPENTINE 150MG · TABLET · ORAL

Approval history

2026-01-27Labeling · Supplement 22 · standard — Letter ↗AP
2020-06-09Labeling · Supplement 20 · standard — Letter ↗AP
2020-06-05Labeling · Supplement 17 · standard — Label ↗AP
2020-06-05Labeling · Supplement 18 · standard — Label ↗AP
2015-08-07Manufacturing (CMC) · Supplement 12AP
2015-07-01Labeling · Supplement 13 · standard — Letter ↗AP
2014-11-25Efficacy · Supplement 11 · priority — Letter ↗AP
2014-11-20Labeling · Supplement 10 · standard — Letter ↗AP
2010-07-30Labeling · Supplement 9 · unknown — Letter ↗AP
2009-06-01Efficacy · Supplement 8 · unknown — Letter ↗AP
2000-12-12Manufacturing (CMC) · Supplement 6AP
2000-10-20Efficacy · Supplement 5 · standard — Review ↗AP
2000-09-13Labeling · Supplement 4 · standardAP
1999-12-10Manufacturing (CMC) · Supplement 3AP
1999-07-22Manufacturing (CMC) · Supplement 2AP
1999-04-21Manufacturing (CMC) · Supplement 1AP
1998-06-22Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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