APPLICATION
ANDA080140
TYPE
ANDA
ORIGINAL APPROVAL
1975-08-29
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LANIAZIDDiscontinued
ISONIAZID 50MG · TABLET · ORAL
LANIAZIDDiscontinued
ISONIAZID 100MG · TABLET · ORAL
Approval history
2025-02-05Labeling · Supplement 13 · standardAP
2025-01-29Labeling · Supplement 12 · standardAP
1990-01-09Labeling · Supplement 9AP
1975-08-29OriginalAP
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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