APPLICATION
ANDA089753
TYPE
ANDA
ORIGINAL APPROVAL
1988-06-22
LATEST ACTION
2001-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAZOLAMIDEDiscontinued
ACETAZOLAMIDE 125MG · TABLET · ORAL
ACETAZOLAMIDEDiscontinued
ACETAZOLAMIDE 250MG · TABLET · ORAL
Approval history
2001-10-25Labeling · Supplement 10AP
2001-08-08Manufacturing (CMC) · Supplement 9AP
2000-05-16Manufacturing (CMC) · Supplement 8AP
2000-05-16Manufacturing (CMC) · Supplement 7AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1997-02-24Manufacturing (CMC) · Supplement 5AP
1995-06-22Manufacturing (CMC) · Supplement 4AP
1994-01-12Manufacturing (CMC) · Supplement 3AP
1992-05-11Labeling · Supplement 2AP
1990-06-08Labeling · Supplement 1AP
1988-06-22OriginalAP
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.