TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

FELODIPINE

FELODIPINE
Approved 2004-11-02
Jump to: Indications Approvals Trials Competitors Safety Patents
13
Indications
--
Phase 3 Trials
21
Years on Market

Details

Status
Discontinued
First Approved
2004-11-02
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

Viatris ORBION PHARMS YILING YUNG SHIN PHARM Sun Pharma GLENMARK PHARMS LTD TORRENT PHARMS LTD Aurobindo Pharma JUBILANT GENERICS WOCKHARDT BIO AG PH HEALTH HERITAGE
Active Ingredient: FELODIPINE

FELODIPINE Approval History

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What FELODIPINE Treats

13 FDA approvals

Originally approved for its first indication in 2004 . Covers 13 distinct patient populations.

  • Other (13)
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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.

FELODIPINE FDA Label Details

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Data Sources

FDA Approval: ANDA078855 → Trials: ClinicalTrials.gov →

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