Track testosterone in Peptimes™
Testosterone is an androgen, a steroid hormone. FDA-approved gels, the nasal gel and pellets contain testosterone itself; the capsules and injections contain one of its esters, such as testosterone enanthate or undecanoate. (Source: DailyMed label.)
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.
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.
More sources
- eCFR, 21 CFR 1308.13(f), “Anabolic steroids”, read 1 Nov 2026: testosterone, “including its salts, esters and ethers”, in Schedule III.
- DEA Diversion Control Division, Controlled Substance Schedules, checked 1 Nov 2026.
- FDA, Drugs@FDA, checked 1 Nov 2026: product, route and marketing status for NDA 021015 and NDA 022309 (AndroGel), NDA 021454 (Testim), NDA 204399 (Vogelxo), NDA 021463 (Fortesta, discontinued), NDA 020489 (Androderm, discontinued), NDA 205488 (Natesto), ANDA 080911 (Testopel), NDA 206089 (Jatenzo), NDA 208088 (Tlando), NDA 213953 (Kyzatrex), NDA 022219 (Aveed), NDA 209863 (Xyosted), ANDA 091120, ANDA 212659 and ANDA 040575 (generic testosterone enanthate), NDA 009165 (Delatestryl, discontinued) and ANDA 080188 (testosterone propionate, discontinued).
- DailyMed labels, section 1, checked 1 Nov 2026: AndroGel, Testim, Vogelxo, Tlando and Kyzatrex.
- FDA, Compounding and the FDA: questions and answers, read 1 Nov 2026: “Compounded drugs are not FDA-approved.”
- Sustanon 250, UK Summary of Product Characteristics, on the electronic medicines compendium (emc), read 1 Nov 2026: marketing authorisation PL 39699/0059, held by Aspen Pharma Trading Limited, first authorised in 1973, for intramuscular injection.
- FDA, Global Substance Registration System, Testosterone, checked 1 Nov 2026.
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