APPLICATION
ANDA214219
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-20
LATEST ACTION
2023-11-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIAZOLAMPrescription
TRIAZOLAM 0.25MG · TABLET · ORAL
TRIAZOLAMPrescription
TRIAZOLAM 0.125MG · TABLET · ORAL
Approval history
2023-11-28Labeling · Supplement 5 · standardAP
2022-07-26Labeling · Supplement 4 · standardAP
2022-07-26Labeling · Supplement 3 · standardAP
2022-07-26Labeling · Supplement 1 · standardAP
2020-10-20UNKNOWN · Original · standardAP
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.