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As of Nov 14, 2026, ANDA 216159 (Midazolam In 0.9% Sodium Chloride), held by Hikma, was first approved by FDA on Apr 17, 2023, with 1 approved supplement and 0 published complete response letters.
First approved: Apr 17, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Midazolam in sodium chloride injection is indicated: Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. Midazolam in sodium chloride injection is a benzodiazepine indicated for: continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
