APPLICATION
ANDA070290
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-13
LATEST ACTION
2001-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLAZAMIDEDiscontinued
TOLAZAMIDE 500MG · TABLET · ORAL
Approval history
2001-05-09Manufacturing (CMC) · Supplement 12AP
1996-04-03Manufacturing (CMC) · Supplement 11AP
1995-10-24Manufacturing (CMC) · Supplement 10AP
1992-07-24Labeling · Supplement 8AP
1990-03-14Manufacturing (CMC) · Supplement 7AP
1989-05-09Labeling · Supplement 6AP
1988-11-08Manufacturing (CMC) · Supplement 5AP
1987-12-23Manufacturing (CMC) · Supplement 3AP
1987-12-23Manufacturing (CMC) · Supplement 1AP
1987-12-23Manufacturing (CMC) · Supplement 2AP
1986-03-13OriginalAP
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.