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Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

METHYLERGONOVINE MALEATE

METHYLERGONOVINE MALEATE
Gastroenterology Approved 2008-11-24
8
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-11-24
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE

METHYLERGONOVINE MALEATE Approval History

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What METHYLERGONOVINE MALEATE Treats

3 indications

METHYLERGONOVINE MALEATE is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Uterine Atony
  • Hemorrhage
  • Subinvolution of the Uterus
Source: FDA Label
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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.

METHYLERGONOVINE MALEATE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Following delivery of placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus. For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.

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Data Sources

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