TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

SODIUM ACETATE

SODIUM ACETATE
Approved 1983-05-04
6
Indications
--
Phase 3 Trials
42
Years on Market

Details

Status
Prescription
First Approved
1983-05-04
Routes
INTRAVENOUS
Dosage Forms
SOLUTION

SODIUM ACETATE Approval History

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What SODIUM ACETATE Treats

1 indications

SODIUM ACETATE is approved for 1 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hyponatremia
Source: FDA Label

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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 ACETATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Sodium Acetate Injection, USP 40 mEq is indicated as a source of sodium, for addition to large volume intravenous fluids to prevent or correct hyponatremia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.