TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

METHYLTESTOSTERONE

METHYLTESTOSTERONE
Approved 1971-12-22
Jump to: Indications Approvals Trials Competitors Safety Patents
13
Indications
--
Phase 3 Trials
54
Years on Market

Details

Status
Discontinued
First Approved
1971-12-22
Routes
ORAL, BUCCAL, SUBLINGUAL
Dosage Forms
TABLET, CAPSULE

Companies

PUREPAC PHARM TABLICAPS WATSON LABS PVT FORM IMPAX LABS Hikma IMPAX LABS INC USL PHARMA LANNETT INWOOD LABS PARKE DAVIS NOVITIUM PHARMA HEATHER Eli Lilly KV PHARM
Active Ingredient: METHYLTESTOSTERONE

METHYLTESTOSTERONE Approval History

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What METHYLTESTOSTERONE Treats

13 FDA approvals

Originally approved for its first indication in 1971 . Covers 13 distinct patient populations.

  • Other (13)
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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

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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.

METHYLTESTOSTERONE FDA Label Details

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Data Sources

FDA Approval: ANDA080310 → Trials: ClinicalTrials.gov →

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