APPLICATION
ANDA074445
TYPE
ANDA
ORIGINAL APPROVAL
1995-10-20
LATEST ACTION
1999-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRIAZOLAMDiscontinued
TRIAZOLAM 0.125MG · TABLET · ORAL
TRIAZOLAMDiscontinued
TRIAZOLAM 0.25MG · TABLET · ORAL
Approval history
1999-04-19Manufacturing (CMC) · Supplement 5AP
1998-03-12Manufacturing (CMC) · Supplement 3AP
1998-03-12Manufacturing (CMC) · Supplement 4AP
1997-01-24Manufacturing (CMC) · Supplement 1AP
1996-11-29Labeling · Supplement 2AP
1995-10-20OriginalAP
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.