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Data updated: Mar 10, 2026

INDAPAMIDE

INDAPAMIDE
Cardiovascular Approved 1995-07-27
8
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Prescription
First Approved
1995-07-27
Routes
ORAL
Dosage Forms
TABLET

INDAPAMIDE Approval History

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What INDAPAMIDE Treats

4 indications

INDAPAMIDE is approved for 4 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Fluid Retention
  • Congestive Heart Failure
  • Edema
Source: FDA Label

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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.

INDAPAMIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

INDICATIONS Indapamide tablets are indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs. Indapamide tablets are also indicated for the treatment of salt and fluid retention associated with congestive heart failure. Usage in Pregnancy : The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard (see PRECAUTIONS below). Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. Ed...

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Data Sources

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