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Data updated: Mar 10, 2026

MILRINONE LACTATE IN PLASTIC CONTAINER

MILRINONE LACTATE
Cardiovascular Approved 2010-01-21
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2010-01-21
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Hikma
Active Ingredient: MILRINONE LACTATE

MILRINONE LACTATE IN PLASTIC CONTAINER Approval History

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What MILRINONE LACTATE IN PLASTIC CONTAINER Treats

1 indications

MILRINONE LACTATE IN PLASTIC CONTAINER is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Heart Failure
Source: FDA Label

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Trial Timeline

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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.

MILRINONE LACTATE IN PLASTIC CONTAINER FDA Label Details

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Indications & Usage

Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving milrinone lactate should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone lactate has been in patients receiving digoxin and diuretics.

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Data Sources

FDA Approval: ANDA090038 → Label: DailyMed → Trials: ClinicalTrials.gov →

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