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Data updated: Mar 10, 2026

MIDAMOR

AMILORIDE HYDROCHLORIDE
Cardiovascular Approved 1981-10-05
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
44
Years on Market

Details

Status
Prescription
First Approved
1981-10-05
Routes
ORAL
Dosage Forms
TABLET

Companies

PADAGIS US
Active Ingredient: AMILORIDE HYDROCHLORIDE

MIDAMOR Approval History

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What MIDAMOR Treats

4 indications

MIDAMOR is approved for 4 conditions since its original approval in 1981. 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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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

MIDAMOR FDA Label Details

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Indications & Usage

FDA Label (PDF)

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: NDA018200 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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