TESTOSTERONE ENANTHATE
Details
- Status
- Prescription
- First Approved
- 1980-12-10
- Routes
- INJECTION, Injection
- Dosage Forms
- INJECTABLE, Injectable
TESTOSTERONE ENANTHATE Approval History
What TESTOSTERONE ENANTHATE Treats
3 indicationsTESTOSTERONE ENANTHATE is approved for 3 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Primary Hypogonadism
- Hypogonadotropic Hypogonadism
- Delayed Puberty
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Active Pipeline
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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.
TESTOSTERONE ENANTHATE FDA Label Details
ProIndications & Usage
Males Testosterone enanthate injection is indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired) โ Testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired) โ Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still n...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.