What is DROPERIDOL used for?

DROPERIDOL is an FDA-approved medication. See full prescribing information for approved uses.

Is DROPERIDOL FDA approved?

Yes, DROPERIDOL is FDA approved (first approved 1986-11-17) and manufactured by Pfizer.

Who makes DROPERIDOL?

DROPERIDOL is manufactured by Pfizer.

Data updated: Mar 10, 2026

DROPERIDOL

Approved 1986-11-17

Jump to: Indications Approvals Trials Competitors Safety Patents

Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1986-11-17
Routes: INJECTION, Injection
Dosage Forms: INJECTABLE, Injectable

Companies

Pfizer ABRAXIS PHARM SOLOPAK QUAD PHARMS IGI LABS INC WATSON LABS SMITH AND NEPHEW AstraZeneca LUITPOLD Hikma AM REGENT

Active Ingredient: DROPERIDOL

DROPERIDOL Approval History

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What DROPERIDOL Treats

10 FDA approvals

Originally approved for its first indication in 1986 . Covers 10 distinct patient populations.

Other (10)

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Active Pipeline

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Ongoing clinical trials by development phase

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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

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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.

DROPERIDOL FDA Label Details

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Data Sources

FDA Approval: ANDA071645 → Trials: ClinicalTrials.gov →

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