TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ISRADIPINE

ISRADIPINE Calcium Channel Antagonists
Cardiovascular Approved 2006-01-05
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Prescription
First Approved
2006-01-05
Routes
ORAL
Dosage Forms
CAPSULE, TABLET, EXTENDED RELEASE

Companies

ELITE LABS INC WATSON LABS TEVA PHARMOBEDIENT
Active Ingredient: ISRADIPINE

ISRADIPINE Approval History

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What ISRADIPINE Treats

1 indications

ISRADIPINE is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
Source: FDA Label

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Hypertension
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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.

ISRADIPINE FDA Label Details

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Indications & Usage

Hypertension Isradipine capsules are indicated in the management of hypertension. It may be used alone or concurrently with thiazide-type diuretics.

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Data Sources

FDA Approval: ANDA077169 → Label: DailyMed → Trials: ClinicalTrials.gov →

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