SODIUM CHLORIDE 23.4%
Details
- Status
- Prescription
- First Approved
- 1984-07-20
- Routes
- INTRAVENOUS, INJECTION
- Dosage Forms
- SOLUTION, INJECTABLE
SODIUM CHLORIDE 23.4% Approval History
What SODIUM CHLORIDE 23.4% Treats
3 FDA approvalsOriginally approved for its first indication in 1984 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Jul 1984)
- • Approved indication (Apr 2021)Letter
- • Approved indication (Jul 2023)
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SODIUM CHLORIDE 23.4% FDA Label Details
ProIndications & Usage
FDA Label (PDF)This sterile, nonpyrogenic electrolyte solution is indicated for all general irrigation, washing, rinsing and dilution purposes including blood cell washing (when used in conjunction with automated intraoperative blood salvaging equipment).
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.