APPLICATION
ANDA088231
TYPE
ANDA
ORIGINAL APPROVAL
1983-03-17
LATEST ACTION
1991-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISONIAZIDDiscontinued
ISONIAZID 100MG · TABLET · ORAL
Approval history
1991-03-26Labeling · Supplement 21AP
1989-08-17Labeling · Supplement 14AP
1989-05-03Labeling · Supplement 15AP
1988-12-29Manufacturing (CMC) · Supplement 13AP
1988-04-14Labeling · Supplement 12AP
1985-06-19Manufacturing (CMC) · Supplement 10AP
1985-06-19Manufacturing (CMC) · Supplement 9AP
1985-06-19Manufacturing (CMC) · Supplement 7AP
1985-05-28Manufacturing (CMC) · Supplement 6AP
1985-05-28Manufacturing (CMC) · Supplement 5AP
1984-04-03Manufacturing (CMC) · Supplement 3AP
1983-08-05Manufacturing (CMC) · Supplement 1AP
1983-03-17OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.