APPLICATION
ANDA091383
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-23
LATEST ACTION
2024-02-12
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
LORAZEPAMPrescription
LORAZEPAM 2MG/ML · CONCENTRATE · ORAL
Approval history
2024-02-12Labeling · Supplement 9 · standardAP
2024-02-12Labeling · Supplement 5 · standardAP
2020-10-02Labeling · Supplement 2 · standardAP
2020-10-02Labeling · Supplement 4 · standardAP
2009-12-23OriginalAP
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.