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Data updated: Mar 10, 2026

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE

TRANDOLAPRIL Angiotensin-converting Enzyme Inhibitors
Cardiovascular Approved 2010-05-05
3
Indications
--
Phase 3 Trials
15
Years on Market

Details

Status
Prescription
First Approved
2010-05-05
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

Active Ingredient: TRANDOLAPRIL , VERAPAMIL HYDROCHLORIDE

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE Approval History

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What TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE Treats

1 indications

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
Source: FDA Label

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE Boxed Warning

FETAL TOXICITY • When pregnancy is detected, discontinue trandolapril and verapamil hydrochloride extended-release tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS: Fetal Toxicity ) ....

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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.

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE FDA Label Details

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Indications & Usage

Trandolapril and verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using trandolapril and verapamil hydrochloride extended-release tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that trandolapril does not have si...

⚠️ BOXED WARNING

WARNING: FETAL TOXICITY • When pregnancy is detected, discontinue trandolapril and verapamil hydrochloride extended-release tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (see WARNINGS: Fetal Toxicity ) ....

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Data Sources

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