Is testosterone FDA-approved?

Yes, as specific products: testosterone gels, a nasal gel, pellets, capsules and injections are FDA-approved for the uses in their labels. Testosterone is a Schedule III controlled substance · prescription only.

Checked 1 Nov 2026. The sources are below.

Testosterone

Also: testosterone enanthate, testosterone undecanoate, testosterone propionate, AndroGel, Testim, Vogelxo, Natesto, Testopel, Jatenzo, Tlando, Kyzatrex, Aveed, Xyosted, Sustanon 250

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
TopicalNasalOtherOralIntramuscularSubcutaneous
Controlled substance
Schedule III controlled substance · prescription only.
Updated
1 Nov 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.

  • AndroGel, Testim, Vogelxo and generic testosterone gels and topical solutions

    Transdermal

    Testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism, as stated in each product's label. The Fortesta gel and the Androderm patch are discontinued.

    Source: DailyMed label, checked 1 Nov 2026

  • Natesto (testosterone) nasal gel

    Nasal

    Testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism, as stated in its label.

    Source: DailyMed label, checked 1 Nov 2026

  • Testopel (testosterone) pellets

    Implanted under the skin

    Testosterone replacement in males with primary or hypogonadotropic hypogonadism, and stimulating puberty in carefully selected males with clearly delayed puberty, as stated in its label.

    Source: DailyMed label, checked 1 Nov 2026

  • Jatenzo, Tlando and Kyzatrex (testosterone undecanoate) capsules

    Oral

    Testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism, as stated in each product's label.

    Source: DailyMed label, checked 1 Nov 2026

  • Aveed (testosterone undecanoate) injection

    Intramuscular

    Testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism, as stated in its label.

    Source: DailyMed label, checked 1 Nov 2026

  • Xyosted (testosterone enanthate) autoinjector

    Subcutaneous

    Testosterone replacement therapy in adult males with primary or hypogonadotropic hypogonadism, as stated in its label.

    Source: DailyMed label, checked 1 Nov 2026

  • Generic testosterone enanthate injection, from several manufacturers

    Intramuscular

    In males, replacement therapy in primary or hypogonadotropic hypogonadism and stimulating puberty in carefully selected males with clearly delayed puberty; in females, secondary use in some women with advancing inoperable metastatic breast cancer, as stated in its label. The Delatestryl brand is discontinued.

    Source: DailyMed label, checked 1 Nov 2026

  • Testosterone propionate injection

    Intramuscular

    No marketed US product. Generic testosterone propionate injections were FDA-approved, but Drugs@FDA lists every one as discontinued.

    Source: Drugs@FDA, checked 1 Nov 2026

  • Sustanon 250 (testosterone propionate, phenylpropionate, isocaproate and decanoate)

    None approved in the US

    Not FDA-approved. Drugs@FDA lists no product with its phenylpropionate, isocaproate or decanoate esters. It is authorised in the UK (licence PL 39699/0059), which doesn't apply in the US.

    Source: Drugs@FDA, checked 1 Nov 2026

  • Compounded testosterone, such as creams and pellets

    None approved

    Not FDA-Approved. Compounded drugs are not FDA-approved, and Drugs@FDA lists no testosterone cream.

    Source: FDA, checked 1 Nov 2026

  • Controlled substance

    Schedule III controlled substance · prescription only.

    Source: DEA, Controlled Substance Schedules, checked 1 Nov 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

Federal regulations name testosterone among the anabolic steroids in Schedule III, “including its salts, esters and ethers” (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.

How to track it in Peptimes

The Library has a separate entry for each form of testosterone, so pick the one that matches your product, add it 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. Each entry shows its own status label. The list above gives the detail by product.

  • Entries and routes: “Testosterone (transdermal gel/cream)” is topical; “Testosterone (nasal)” is nasal; “Testosterone pellets” is logged as Other; “Testosterone Undecanoate (oral)” is oral; “Testosterone Undecanoate (injectable)” is intramuscular; “Testosterone Enanthate” is intramuscular or subcutaneous. These six show “FDA Approved”.
  • Other labels: “Testosterone Propionate” shows “Compoundable” and can be logged as intramuscular or topical. That label isn’t an FDA approval: no testosterone propionate product is marketed in the US. “Sustanon 250” shows “Approved outside the US” and is intramuscular; it isn’t FDA-approved.
  • Testosterone cypionate has its own entry and its own page.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: intramuscular and subcutaneous doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Topical, nasal, oral and Other doses skip this step.
  • Reminders and history: reminders at your times, 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.

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