← FDA DRUG APPROVALS

FDA NDA · NDA211844

MIDAZOLAM IN SODIUM CHLORIDE

midazolam

Sponsor: INFORLIFE

APPLICATION
NDA211844
TYPE
NDA
ORIGINAL APPROVAL
2021-03-22
LATEST ACTION
2024-07-18
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

MIDAZOLAM IN 0.9% SODIUM CHLORIDE · ReferencePrescription
MIDAZOLAM 100MG/100ML (1MG/ML) · SOLUTION · INTRAVENOUS
MIDAZOLAM IN 0.9% SODIUM CHLORIDE · ReferencePrescription
MIDAZOLAM 50MG/50ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-07-18Labeling · Supplement 5 · standard — Label ↗AP
2023-01-13Labeling · Supplement 4 · standard — Letter ↗AP
2021-10-19Labeling · Supplement 1 · standard — Letter ↗AP
2021-03-22Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →