TESTOSTERONE CYPIONATE
Details
- Status
- Prescription
- First Approved
- 1978-06-23
- Routes
- INJECTION, Injection
- Dosage Forms
- INJECTABLE, Injectable
Companies
TESTOSTERONE CYPIONATE Approval History
What TESTOSTERONE CYPIONATE Treats
1 indicationsTESTOSTERONE CYPIONATE is approved for 1 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypogonadism
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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 CYPIONATE FDA Label Details
ProIndications & Usage
Testosterone cypionate 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 testosterone cypionate injection in men with βageΒ-related hypogonadismβ (also r...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.