TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

TESTOSTERONE

TESTOSTERONE
Approved 1983-05-10
Jump to: Indications Approvals Trials Competitors Safety Patents
24
Indications
--
Phase 3 Trials
42
Years on Market

Details

Status
Discontinued
First Approved
1983-05-10
Routes
INJECTION, TRANSDERMAL
Dosage Forms
INJECTABLE, GEL, GEL, METERED, SOLUTION, METERED

Companies

WATSON LABS Teva TWI PHARMS ENCUBE ALEMBIC Dr. Reddy's PADAGIS ISRAEL Lupin Apotex Cipla STRIDES PHARMA INTL PERRIGO ISRAEL XIROMED Novartis ANI PHARMS AMNEAL
Active Ingredient: TESTOSTERONE

TESTOSTERONE Approval History

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What TESTOSTERONE Treats

24 FDA approvals

Originally approved for its first indication in 1983 . Covers 24 distinct patient populations.

  • Other (24)
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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.

TESTOSTERONE FDA Label Details

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Data Sources

FDA Approval: ANDA086420 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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