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FDA NDA · NDA050420

RIFADIN

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA050420
TYPE
NDA
ORIGINAL APPROVAL
1971-05-21
LATEST ACTION
2025-12-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

RIFADIN · ReferenceDiscontinued
RIFAMPIN 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
RIFADIN · ReferenceDiscontinued
RIFAMPIN 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2025-12-05Labeling · Supplement 94 · standard — Letter ↗AP
2025-10-08Labeling · Supplement 93 · standard — Label ↗AP
2024-10-10Labeling · Supplement 92 · standard — Label ↗AP
2023-12-08Labeling · Supplement 91 · standard — Letter ↗AP
2023-08-16Labeling · Supplement 90 · standard — Letter ↗AP
2023-02-17Labeling · Supplement 89 · standard — Letter ↗AP
2023-02-10Labeling · Supplement 88 · standard — Letter ↗AP
2022-01-29Labeling · Supplement 87 · standard — Letter ↗AP
2021-10-21Labeling · Supplement 86 · standard — Label ↗AP
2021-06-17Labeling · Supplement 85 · standard — Letter ↗AP
2020-05-12Labeling · Supplement 84 · standard — Letter ↗AP
2019-08-27Labeling · Supplement 83 · standard — Label ↗AP
2019-02-28Labeling · Supplement 80 · standard — Letter ↗AP
2019-01-23Labeling · Supplement 78 · standard — Label ↗AP
2018-01-08Labeling · Supplement 77 · standard — Label ↗AP
2017-04-24Labeling · Supplement 76 · standard — Label ↗AP
2013-02-27Labeling · Supplement 75 · standard — Label ↗AP
2010-11-10Labeling · Supplement 73 · standard — Label ↗AP
2004-08-20Labeling · Supplement 72 · standard — Label ↗AP
2000-04-12Labeling · Supplement 71 · standardAP
2000-04-12Labeling · Supplement 70 · standardAP
1996-09-17Labeling · Supplement 67 · standardAP
1996-01-05Manufacturing (CMC) · Supplement 64AP
1995-09-05Manufacturing (CMC) · Supplement 68AP
1994-07-12Manufacturing (CMC) · Supplement 66AP
1993-06-18Labeling · Supplement 63AP
1990-02-12Manufacturing (CMC) · Supplement 9AP
1990-02-12Labeling · Supplement 7AP
1989-05-18Manufacturing (CMC) · Supplement 13AP
1987-11-16Manufacturing (CMC) · Supplement 14AP
1986-02-18Manufacturing (CMC) · Supplement 11AP
1984-09-12Labeling · Supplement 12AP
1984-02-08Manufacturing (CMC) · Supplement 10AP
1983-09-02Labeling · Supplement 8AP
1982-11-17Manufacturing (CMC) · Supplement 5AP
1982-11-15Manufacturing (CMC) · Supplement 4AP
1982-11-15Manufacturing (CMC) · Supplement 3AP
1982-10-26Manufacturing (CMC) · Supplement 2AP
1982-10-05Manufacturing (CMC) · Supplement 1AP
1982-09-11Manufacturing (CMC) · Supplement 59AP
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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