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Data updated: Mar 10, 2026

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE

ENALAPRIL MALEATE
Cardiovascular Approved 2001-09-18
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
24
Years on Market

Details

Status
Prescription
First Approved
2001-09-18
Routes
ORAL
Dosage Forms
TABLET

Companies

SENORES PHARMS CHARTWELL RX RISING COSETTE TARO PHARM INDS MPP PHARMA IVAX SUB TEVA PHARMS
Active Ingredient: ENALAPRIL MALEATE , HYDROCHLOROTHIAZIDE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Approval History

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What ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Treats

2 indications

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE is approved for 2 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Angioedema
Source: FDA Label

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE Boxed Warning

FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue enalapril maleate and hydrochlorothiazide 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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VASERETIC
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AZOR
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COREPHARMA
Shared indications:
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BENICAR
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Shared indications:
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Trial Timeline

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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.

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Enalapril maleate and hydrochlorothiazide is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial treatment (see DOSAGE AND ADMINISTRATION ). In using enalapril maleate and hydrochlorothiazide, 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 enalapril mal...

⚠️ BOXED WARNING

WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue enalapril maleate and hydrochlorothiazide as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See ...

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Data Sources

FDA Approval: ANDA075909 → Label: DailyMed → Trials: ClinicalTrials.gov →

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