APPLICATION
ANDA071359
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-16
LATEST ACTION
2006-09-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLAZAMIDEDiscontinued
TOLAZAMIDE 500MG · TABLET · ORAL
Approval history
2006-09-28Labeling · Supplement 20AP
2000-05-16Manufacturing (CMC) · Supplement 10AP
2000-05-16Manufacturing (CMC) · Supplement 11AP
1997-12-05Manufacturing (CMC) · Supplement 9AP
1997-02-24Manufacturing (CMC) · Supplement 8AP
1995-06-22Manufacturing (CMC) · Supplement 6AP
1994-01-03Manufacturing (CMC) · Supplement 5AP
1991-08-08Labeling · Supplement 4AP
1988-08-25Manufacturing (CMC) · Supplement 2AP
1988-08-25Manufacturing (CMC) · Supplement 3AP
1988-08-25Manufacturing (CMC) · Supplement 1AP
1987-07-16OriginalAP
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.