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Data updated: Jun 28, 2026

VERELAN (verapamil hydrochloride) · AZURITY

Cardiovascular Approved 1990-05-29

Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug.

NDA
Small Molecule
1
Indication
--
Phase 3 Trials
36
Years on Market

Details

Status
Prescription
First Approved
1990-05-29
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Active Ingredient: VERAPAMIL HYDROCHLORIDE

VERELAN Approval History

1991
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Original
New Indication
New Form
Label Update
140 FDA actions from 1990 to 2019
Oct 2019 SUPPL
Label · Labeling
Nov 2016 SUPPL
Label · Labeling
Oct 2014 SUPPL
Label · Labeling

What VERELAN Treats

5 indications

VERELAN is approved for 5 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

VERELAN 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.

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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT04609826 DHODH CR108874 74856665AML1001, 2020-002375-35 Ph 1 completed A Study of JNJ-74856665 in Participants With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
NCT03013933 16414 NCI-2016-02062, 16414 Ph 1 completed Brentuximab Vedotin, Cyclosporine, and Verapamil Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma
NCT03098680 PRIME PRIME (A094136) Ph 1 terminated A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
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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.

VERELAN FDA Label Details

Indications & Usage

FDA Label (PDF)

Verapamil hydrochloride sustained-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation,...

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Data Sources

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