TheraRadar
Data updated: May 26, 2026

EDECRIN (ethacrynate sodium)

Cardiovascular Approved 1967-01-10

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

Source: FDA Label • BAUSCH
1
Indication
--
Phase 3 Trials
59
Years on Market

Details

Status
Prescription
First Approved
1967-01-10
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, TABLET

Companies

Active Ingredient: ETHACRYNATE SODIUM

EDECRIN Approval History

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Original
New Indication
New Form
Label Update
100 FDA actions from 1967 to 2015
Mar 2015 SUPPL
Mfg · Manufacturing (CMC)
Jul 2005 SUPPL
Mfg · Manufacturing (CMC)
Feb 2005 SUPPL
Label · Labeling

What EDECRIN Treats

8 indications

EDECRIN is approved for 8 conditions since its original approval in 1967. 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

EDECRIN 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.

Drugs Similar to EDECRIN

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Shared indications:
BUMETANIDE
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ZYDUS PHARMS
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VALIDUS PHARMS
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Active Pipeline

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Ongoing clinical trials by development phase

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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.

EDECRIN FDA Label Details

Indications & Usage

FDA Label (PDF)

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

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Data Sources

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