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FDA NDA · NDA050689

RIFABUTIN

Sponsor: PFIZER

APPLICATION
NDA050689
TYPE
NDA
ORIGINAL APPROVAL
1992-12-23
LATEST ACTION
2024-11-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MYCOBUTIN · ReferencePrescription
RIFABUTIN 150MG · CAPSULE · ORAL

Approval history

2024-11-20Labeling · Supplement 27 · standard — Label ↗AP
2021-09-15Labeling · Supplement 26 · standard — Letter ↗AP
2021-03-08Labeling · Supplement 25 · standard — Letter ↗AP
2015-07-01Labeling · Supplement 22 · standard — Label ↗AP
2014-11-13Labeling · Supplement 18 · standard — Label ↗AP
2008-05-14Labeling · Supplement 16 · standard — Label ↗AP
2001-11-09Labeling · Supplement 13 · standard — Letter ↗AP
2001-11-09Labeling · Supplement 11 · standard — Label ↗AP
2001-01-29Manufacturing (CMC) · Supplement 14AP
1999-01-15Manufacturing (CMC) · Supplement 12AP
1996-09-13Manufacturing (CMC) · Supplement 10AP
1996-01-11Manufacturing (CMC) · Supplement 7AP
1995-11-03Labeling · Supplement 8 · standardAP
1995-09-08Manufacturing (CMC) · Supplement 4AP
1994-06-06Manufacturing (CMC) · Supplement 6AP
1994-05-31Manufacturing (CMC) · Supplement 5AP
1993-07-28Manufacturing (CMC) · Supplement 2AP
1993-07-26Labeling · Supplement 1 · standardAP
1993-06-22Manufacturing (CMC) · Supplement 3AP
1992-12-23Type 1 - New Molecular Entity · Original · priorityAP
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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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