What is METHYLDOPA used for?

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

Is METHYLDOPA FDA approved?

Yes, METHYLDOPA is FDA approved (first approved 1984-06-29) and manufactured by WATSON LABS.

Who makes METHYLDOPA?

METHYLDOPA is manufactured by WATSON LABS.

Data updated: Mar 10, 2026

METHYLDOPA

Approved 1984-06-29

Jump to: Indications Approvals Trials Competitors Safety Patents

Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1984-06-29
Routes: ORAL
Dosage Forms: TABLET

Companies

WATSON LABS STRIDES PHARMA INTL HALSEY Teva CHARTWELL RX Sun Pharma ROXANE DURAMED PHARMS BARR PLIVA ACCORD HLTHCARE PARKE DAVIS Viatris HERITAGE PHARMA PUREPAC PHARM RISING SUPERPHARM

Active Ingredient: METHYLDOPA

METHYLDOPA Approval History

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What METHYLDOPA Treats

11 FDA approvals

Originally approved for its first indication in 1984 . Covers 11 distinct patient populations.

Other (11)

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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.

METHYLDOPA FDA Label Details

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Data Sources

FDA Approval: ANDA070246 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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