What is NORLUTATE used for?

NORLUTATE is indicated for Secondary Amenorrhea; Endometriosis; Abnormal Uterine Bleeding.

Is NORLUTATE FDA approved?

Yes, NORLUTATE is FDA approved and manufactured by PARKE DAVIS.

NORLUTATE is manufactured by PARKE DAVIS.

Data updated: Jun 28, 2026

NORLUTATE (norethindrone acetate) · PARKE DAVIS

Women's Health

NORLUTATE is FDA-approved to treat 3 conditions (same as NORETHINDRONE ACETATE).

Source: FDA Label

Jump to: Indications Approvals Trials Competitors Safety Patents

Details

Status: Discontinued
First Approved: N/A
Routes: ORAL
Dosage Forms: TABLET

Companies

PARKE DAVIS

Active Ingredient: NORETHINDRONE ACETATE

NORLUTATE Approval History

No approval records found

What NORLUTATE Treats

3 indications

NORLUTATE is approved for 3 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.

Secondary Amenorrhea
Endometriosis
Abnormal Uterine Bleeding

Same approved indications as NORETHINDRONE ACETATE (same active ingredient).

Source: FDA Label

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Clinical Trial Registry

4 trials

Trial	Sponsor ID	Phase	Status	Title
NCT04527003 results posted	STUDY00013752	Ph 3	terminated	Cannabidiol and Management of Endometriosis Pain
NCT03970330 results posted	Study00011187	Ph 3	terminated	Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis
NCT02542410 results posted	P00018628	Ph 2	completed	Dopamine Receptor Agonist Therapy for Pain Relief in Women Suffering From Endometriosis: A Pilot Study
NCT01140217 Simplify	NE0906	Ph 3	completed	Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

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.

NORLUTATE FDA Label Details

Indications & Usage

NORLUTATE is FDA-approved to treat 3 conditions — same approved indications as NORETHINDRONE ACETATE.

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Data Sources

FDA Approval: NDA012184 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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