MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Post-LOE

midazolam hydrochloride

Gland Pharma

ANDAINTRAVENOUSSOLUTION

Approved

Aug 2024

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

3/8 — Basic

MIDAZOLAM IN 0.9% SODIUM CHLORIDE (midazolam hydrochloride) by Gland Pharma is short-acting benzodiazepine central nervous system (cns) depressant. First approved in 2024.

Drug data last refreshed 22h ago

Mechanism of Action

short-acting benzodiazepine central nervous system (CNS) depressant.

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (2)

NCT03336450Phase 3Completed

Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting

Started Apr 2018

3 enrolled

Nervous System Diseases

NCT03336645Phase 3Completed

Open-label Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Children With Status Epilepticus (Convulsive) in a Healthcare Setting in Japan

Started Oct 2017

25 enrolled

Nervous System Diseases

Company

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.