APPLICATION
ANDA090033
TYPE
ANDA
ORIGINAL APPROVAL
2014-02-24
LATEST ACTION
2025-02-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
RIFABUTINDiscontinued
RIFABUTIN 150MG · CAPSULE · ORAL
Approval history
2025-02-26Labeling · Supplement 8 · standardAP
2024-04-12Labeling · Supplement 6 · standardAP
2024-04-12Labeling · Supplement 4 · standardAP
2024-04-12Labeling · Supplement 5 · standardAP
2016-01-10Labeling · Supplement 1 · standardAP
2016-01-10Labeling · Supplement 2 · standardAP
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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