APPLICATION
ANDA076150
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-15
LATEST ACTION
2024-06-07
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LORAZEPAMPrescription
LORAZEPAM 2MG/ML · INJECTABLE · INJECTION
Approval history
2024-06-07Labeling · Supplement 6 · standardAP
2022-08-09Labeling · Supplement 5 · standardAP
2020-06-05Labeling · Supplement 3 · standardAP
2012-09-13Labeling · Supplement 1 · standardAP
2004-11-15OriginalAP
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.