What is NORINYL 1+80 28-DAY used for?

NORINYL 1+80 28-DAY is an FDA-approved medication. See full prescribing information for approved uses.

Is NORINYL 1+80 28-DAY FDA approved?

Yes, NORINYL 1+80 28-DAY is FDA approved (first approved 1968-11-08) and manufactured by GD SEARLE LLC.

Who makes NORINYL 1+80 28-DAY?

NORINYL 1+80 28-DAY is manufactured by GD SEARLE LLC.

Data updated: Mar 10, 2026

NORINYL 1+80 28-DAY

MESTRANOL

Approved 1968-11-08

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1968-11-08
Routes: ORAL-28
Dosage Forms: TABLET

Companies

GD SEARLE LLC

Active Ingredient: MESTRANOL , NORETHINDRONE

NORINYL 1+80 28-DAY Approval History

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What NORINYL 1+80 28-DAY Treats

1 FDA approvals

Originally approved for its first indication in 1968 .

Other (1)

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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.

NORINYL 1+80 28-DAY FDA Label Details

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Data Sources

FDA Approval: NDA016725 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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