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Data updated: Mar 10, 2026

VASERETIC

ENALAPRIL MALEATE
Cardiovascular Approved 1986-10-31
2
Indications
--
Phase 3 Trials
39
Years on Market

Details

Status
Prescription
First Approved
1986-10-31
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: ENALAPRIL MALEATE , HYDROCHLOROTHIAZIDE

VASERETIC Approval History

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What VASERETIC Treats

3 indications

VASERETIC is approved for 3 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Renal Impairment
  • Angioedema
Source: FDA Label

VASERETIC Boxed Warning

FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASERETIC ® 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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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.

VASERETIC FDA Label Details

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Indications & Usage

FDA Label (PDF)

VASERETIC is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using VASERETIC, consideration should be given to the fact that another 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 enalapril does not have a similar risk (see WARNINGS ). In considering use of VASERETIC, it should be noted that black patients receiving ACE inhibitors ha...

⚠️ BOXED WARNING

WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue VASERETIC ® 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.