Is testosterone cypionate FDA-approved?

Yes, as specific products: Depo-Testosterone and generic testosterone cypionate injections are FDA-approved for the use in their labels. Testosterone is a Schedule III controlled substance · prescription only.

Checked 23 Oct 2026. The sources are below.

Testosterone cypionate

Also: testosterone cipionate, testosterone cyclopentanepropionate

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Intramuscular
Controlled substance
Schedule III controlled substance · prescription only.
Updated
25 Oct 2026

US regulatory status

FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Depo-Testosterone (testosterone cypionate) injection

    Intramuscular

    "replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone": primary hypogonadism and hypogonadotropic hypogonadism, congenital or acquired. The label adds: "Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with 'age-related hypogonadism' (also referred to as 'late-onset hypogonadism') have not been established."

    Source: DailyMed label, checked 23 Oct 2026

  • Generic testosterone cypionate injection, from several manufacturers

    Intramuscular

    As stated on each product's label (approved through abbreviated new drug applications, ANDAs).

    Source: Drugs@FDA, checked 23 Oct 2026

  • Controlled substance

    Schedule III controlled substance · prescription only.

    Source: DEA, Controlled Substance Schedules, checked 23 Oct 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 23 Oct 2026

Federal regulations name testosterone among the anabolic steroids in Schedule III (21 CFR 1308.13(f)). DEA’s Controlled Substance Schedules page lists “anabolic steroids such as Depo®-Testosterone” among its examples of Schedule IIIN (non-narcotic Schedule III) substances. The Depo-Testosterone label says it “contains testosterone, a Schedule III controlled substance in the Controlled Substances Act,” and is marked “Rx only.”

How to track it in Peptimes

Add testosterone cypionate in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows “FDA Approved” and, under FDA & Legal Status, “DEA Schedule: Schedule III” with “Controlled substance · prescription only”. Other forms of testosterone have their own Library entries, so pick the one that matches your product.

  • Logging: the amount you took and how you feel.
  • Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the TRT tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell testosterone or any other compound.

More sources

  • eCFR, 21 CFR 1308.13(f), “Anabolic steroids”, read 23 Oct 2026: testosterone, “including its salts, esters and ethers”, in Schedule III.
  • DEA Diversion Control Division, Controlled Substance Schedules, checked 23 Oct 2026.
  • FDA, Drugs@FDA, ANDA 085635 (Depo-Testosterone), checked 23 Oct 2026: product and marketing status.
  • FDA, Global Substance Registration System, Testosterone cypionate, checked 23 Oct 2026: the names testosterone cipionate and testosterone cyclopentanepropionate.

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