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Data updated: Mar 10, 2026

AMILORIDE HYDROCHLORIDE

AMILORIDE HYDROCHLORIDE
Cardiovascular Approved 1986-01-22
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
40
Years on Market

Details

Status
Prescription
First Approved
1986-01-22
Routes
ORAL
Dosage Forms
TABLET

Companies

SIGMAPHARM LABS LLC PH HEALTH CHARTWELL RX
Active Ingredient: AMILORIDE HYDROCHLORIDE

AMILORIDE HYDROCHLORIDE Approval History

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What AMILORIDE HYDROCHLORIDE Treats

4 indications

AMILORIDE HYDROCHLORIDE is approved for 4 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Congestive Heart Failure
  • Hypertension
  • Hypokalemia
  • Cardiac Arrhythmias
Source: FDA Label

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Trial Timeline

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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.

AMILORIDE HYDROCHLORIDE FDA Label Details

Pro

Indications & Usage

Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to: help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when s...

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Data Sources

FDA Approval: ANDA079133 → Label: DailyMed → Trials: ClinicalTrials.gov →

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