TheraRadar
Data updated: Jun 17, 2026

ETHACRYNATE SODIUM

Cardiovascular Approved 2015-07-29

ETHACRYNATE SODIUM is indicated for the treatment of Edema; Congestive Heart Failure; Cirrhosis; Renal Disease; Nephrotic Syndrome; Ascites; Lymphedema; Pulmonary Edema; Congenital Heart Disease.

Source: FDA Label • STERIMAX
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

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2015 to 2020
Jun 2020 ORIGINAL
Update
Nov 2017 ORIGINAL
Update
Aug 2016 ORIGINAL
Update

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

ETHACRYNATE SODIUM Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Active Pipeline

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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

Indications & Usage

ETHACRYNATE SODIUM is indicated for the treatment of Edema; Congestive Heart Failure; Cirrhosis; Renal Disease; Nephrotic Syndrome; Ascites; Lymphedema; Pulmonary Edema; Congenital Heart Disease.

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Data Sources

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