What is PROCHLORPERAZINE used for?

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

Is PROCHLORPERAZINE FDA approved?

Yes, PROCHLORPERAZINE is FDA approved (first approved 1982-06-08) and manufactured by ABLE.

Who makes PROCHLORPERAZINE?

PROCHLORPERAZINE is manufactured by ABLE.

Data updated: Mar 10, 2026

PROCHLORPERAZINE

Approved 1982-06-08

Jump to: Indications Approvals Trials Competitors Safety Patents

Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1982-06-08
Routes: RECTAL, ORAL, INJECTION
Dosage Forms: SUPPOSITORY, TABLET, CONCENTRATE, INJECTABLE

Companies

ABLE WATSON LABS ALPHARMA US PHARMS COSETTE Baxter

Active Ingredient: PROCHLORPERAZINE

PROCHLORPERAZINE Approval History

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What PROCHLORPERAZINE Treats

4 FDA approvals

Originally approved for its first indication in 1982 . Covers 4 distinct patient populations.

Other (4)

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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.

PROCHLORPERAZINE FDA Label Details

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Data Sources

FDA Approval: ANDA040407 → Trials: ClinicalTrials.gov →

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