APPLICATION
ANDA075857
TYPE
ANDA
ORIGINAL APPROVAL
2002-07-22
LATEST ACTION
2023-01-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREEPrescription
MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-01-17Labeling · Supplement 18 · standardAP
2017-09-15Labeling · Supplement 15 · standardAP
2017-04-27Labeling · Supplement 14 · standardAP
2017-04-27Labeling · Supplement 12 · standardAP
2003-04-18Labeling · Supplement 3AP
2002-07-22OriginalAP
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.