TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

IRBESARTAN AND HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE
Approved 2012-03-30
Jump to: Indications Approvals Trials Competitors Safety Patents
14
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Discontinued
First Approved
2012-03-30
Routes
ORAL
Dosage Forms
TABLET

Companies

WATSON LABS INC MACLEODS PHARMS LTD PHARMOBEDIENT PRINSTON INC Apotex Lupin Dr. Reddy's HISUN PHARM HANGZHOU Teva Novartis Hikma ALEMBIC ATLAS PHARMS LLC Aurobindo Pharma UNICHEM
Active Ingredient: HYDROCHLOROTHIAZIDE , IRBESARTAN

IRBESARTAN AND HYDROCHLOROTHIAZIDE Approval History

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What IRBESARTAN AND HYDROCHLOROTHIAZIDE Treats

14 FDA approvals

Originally approved for its first indication in 2012 . Covers 14 distinct patient populations.

  • Other (14)
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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

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.

IRBESARTAN AND HYDROCHLOROTHIAZIDE FDA Label Details

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Data Sources

FDA Approval: ANDA091539 → Trials: ClinicalTrials.gov →

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