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Data updated: Mar 10, 2026

ETHACRYNATE SODIUM

ETHACRYNATE SODIUM
Cardiovascular Approved 2015-07-29
4
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2015-07-29
Routes
INJECTION
Dosage Forms
INJECTABLE

ETHACRYNATE SODIUM Approval History

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What ETHACRYNATE SODIUM Treats

9 indications

ETHACRYNATE SODIUM is approved for 9 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Edema
  • Congestive Heart Failure
  • Cirrhosis
  • Renal Disease
  • Nephrotic Syndrome
  • Ascites
  • Lymphedema
  • Pulmonary Edema
Source: FDA Label

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Key Completed Trials

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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.

ETHACRYNATE SODIUM FDA Label Details

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Indications & Usage

Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4. Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desi...

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Data Sources

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