DEPO-TESTOSTERONE
Details
- Status
- Prescription
- First Approved
- 1979-07-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DEPO-TESTOSTERONE Approval History
What DEPO-TESTOSTERONE Treats
7 indicationsDEPO-TESTOSTERONE is approved for 7 conditions since its original approval in 1979. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypogonadism
- Cryptorchidism
- Orchitis
- Vanishing Testis Syndrome
- Gonadotropin Deficiency
- LHRH Deficiency
- Hypothalamic Injury
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
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.
DEPO-TESTOSTERONE FDA Label Details
ProIndications & Usage
FDA Label (PDF)DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired) - gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with βage-related hypogonadismβ (...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.