APPLICATION
ANDA065221
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-29
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
RIFAMPIN AND ISONIAZIDDiscontinued
ISONIAZID 150MG, RIFAMPIN 300MG · CAPSULE · ORAL
Approval history
2025-02-05Labeling · Supplement 5 · standardAP
2023-08-16Labeling · Supplement 4 · standardAP
2023-08-03Labeling · Supplement 3 · standardAP
2005-07-29OriginalAP
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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