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Data updated: Mar 10, 2026

TIAZAC

DILTIAZEM HYDROCHLORIDE
Cardiovascular Approved 1995-09-11
2
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Prescription
First Approved
1995-09-11
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Active Ingredient: DILTIAZEM HYDROCHLORIDE

TIAZAC Approval History

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What TIAZAC Treats

3 indications

TIAZAC is approved for 3 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Angina
  • Coronary Artery Spasm
Source: FDA Label

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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

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.

TIAZAC FDA Label Details

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Indications & Usage

FDA Label (PDF)

Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are indicated for the management of chronic stable angina and angina due to coronary artery spasm.

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Data Sources

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