APPLICATION
ANDA088235
TYPE
ANDA
ORIGINAL APPROVAL
1983-11-10
LATEST ACTION
2025-02-05
ROUTE
ORAL
DOSAGE FORM
SYRUP
MARKETING STATUS
Prescription
Products
ISONIAZID · ReferencePrescription
ISONIAZID 50MG/5ML · SYRUP · ORAL
Approval history
2025-02-05Labeling · Supplement 11 · standardAP
2025-01-29Labeling · Supplement 8 · standardAP
2000-08-09Manufacturing (CMC) · Supplement 6AP
1999-09-14Labeling · Supplement 5AP
1992-12-14Manufacturing (CMC) · Supplement 4AP
1991-03-20Manufacturing (CMC) · Supplement 3AP
1986-05-29Manufacturing (CMC) · Supplement 1AP
1983-11-10OriginalAP
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.