What is NANDROLONE DECANOATE used for?

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

Is NANDROLONE DECANOATE FDA approved?

Yes, NANDROLONE DECANOATE is FDA approved (first approved 1983-05-17) and manufactured by WATSON LABS.

Who makes NANDROLONE DECANOATE?

NANDROLONE DECANOATE is manufactured by WATSON LABS.

Data updated: Mar 10, 2026

NANDROLONE DECANOATE

Approved 1983-05-17

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Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1983-05-17
Routes: INJECTION, Injection
Dosage Forms: INJECTABLE, Injectable

Companies

WATSON LABS ABRAXIS PHARM AM REGENT EPIC PHARMA LLC QUAD PHARMS

Active Ingredient: NANDROLONE DECANOATE

NANDROLONE DECANOATE Approval History

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What NANDROLONE DECANOATE Treats

4 FDA approvals

Originally approved for its first indication in 1983 . 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.

NANDROLONE DECANOATE FDA Label Details

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Data Sources

FDA Approval: ANDA087599 → Trials: ClinicalTrials.gov →

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