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Data updated: May 26, 2026

CARDIZEM LA (diltiazem hydrochloride)

Cardiovascular Approved 2003-02-06

Cardizem LA is a medication used to manage high blood pressure and chronic stable angina. It helps patients lower their blood pressure, which reduces the risk of serious cardiovascular events like strokes and heart attacks. For those with chest pain, it is used to improve exercise tolerance. This drug can be used alone or in combination with other medications to help patients reach their cardiovascular health goals.

Source: FDA Label • BAUSCH

How CARDIZEM LA Works

This drug works by blocking calcium ions from entering the cells of the heart and blood vessel muscles. This action relaxes the vascular smooth muscle and lowers peripheral resistance, which effectively reduces blood pressure. In cases of angina, it dilates the coronary arteries and lowers the heart's oxygen demand by reducing heart rate and systemic pressure during physical activity.

2
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2003-02-06
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

Active Ingredient: DILTIAZEM HYDROCHLORIDE

CARDIZEM LA Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
48 FDA actions from 2003 to 2025 · 1 indication expansions
Apr 2025 SUPPL
Label · Labeling
Nov 2016 SUPPL
Label · Labeling
Mar 2015 SUPPL
Label · Labeling

What CARDIZEM LA Treats

2 indications

CARDIZEM LA is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Angina
Source: FDA Label

CARDIZEM LA 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

2 trials
Trial Sponsor ID Phase Status Title
NCT07456852 MC250411 NCI-2026-01065, MC250411 Ph 1, Ph 2 not yet recruiting Vasodilator Therapy With Isosorbide Mononitrate or Diltiazem to Reduce Vasotoxicity in Patients With Gastrointestinal Cancer Receiving Fluoropyrimidine Therapy
NCT04777045 EDIT-CMD NL67497.091.19 2018-003518-41 Ph 3 active not recruiting Efficacy of Diltiazem to Improve Coronary Microvascular Dysfunction: a Randomized Clinical Trial
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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.

CARDIZEM LA FDA Label Details

Indications & Usage

FDA Label (PDF)

CARDIZEM LA is indicated for the treatment of Hypertension; Angina.

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Data Sources

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