TheraRadar
Data updated: May 26, 2026

MIDAMOR (amiloride hydrochloride)

Cardiovascular Approved 1981-10-05

MIDAMOR is indicated for the treatment of Congestive Heart Failure; Hypertension; Hypokalemia; Cardiac Arrhythmias.

Source: FDA Label • PADAGIS US
1
Indication
--
Phase 3 Trials
44
Years on Market

Details

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

Companies

Active Ingredient: AMILORIDE HYDROCHLORIDE

MIDAMOR Approval History

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Original
New Indication
New Form
Label Update
27 FDA actions from 1981 to 2003
Feb 2003 SUPPL
Label · Labeling
Jun 2002 SUPPL
Mfg · Manufacturing (CMC)
Mar 2002 SUPPL
Label · Labeling

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

MIDAMOR 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 MIDAMOR

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AMILORIDE HYDROCHLORIDE
AMILORIDE HYDROCHLORIDE
4 shared
CHARTWELL RX
CADUET
AMLODIPINE BESYLATE
2 shared
PHARMACIA
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE
2 shared
WATSON LABS
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Active Pipeline

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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.

MIDAMOR FDA Label Details

Indications & Usage

FDA Label (PDF)

MIDAMOR is indicated for the treatment of Congestive Heart Failure; Hypertension; Hypokalemia; Cardiac Arrhythmias.

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Data Sources

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