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Data updated: Mar 10, 2026

OXYTOCIN

OXYTOCIN
Metabolic Approved 1980-04-29
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
5
Indications
--
Phase 3 Trials
45
Years on Market

Details

Status
Prescription
First Approved
1980-04-29
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Hikma Fresenius Kabi SAGENT PHARMS INC Dr. Reddy's
Active Ingredient: OXYTOCIN

OXYTOCIN Approval History

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What OXYTOCIN Treats

4 indications

OXYTOCIN is approved for 4 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Diabetes
  • Pre-Eclampsia
  • Uterine Inertia
  • Abortion
Source: FDA Label

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Active Pipeline

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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

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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.

OXYTOCIN FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

IMPORTANT NOTICE: Oxytocin Injection, USP (synthetic) is indicated for the medical rather than the elective induction of labor. Available data and information are inadequate to define the benefits to risks considerations in the use of the drug product for elective induction. Elective induction of labor is defined as the initiation of labor for convenience in an individual with a term pregnancy who is free of medical indications. Antepartum Oxytocin injection (synthetic) is indicated for the initiation or improvement of uterine contractions, where this is desirable and considered suitable, in o...

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Data Sources

FDA Approval: NDA018243 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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