Is tamoxifen FDA-approved?

Yes, as specific products: Soltamox oral solution and generic tamoxifen citrate tablets are FDA-approved, by prescription, for the uses in their labels. Nolvadex tablets are discontinued in the US.

Checked 25 Oct 2026. The sources are below.

Tamoxifen

Also: tamoxifen citrate, ICI-46474, Nolvadex, Soltamox

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Oral
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.

  • Soltamox (tamoxifen citrate) oral solution

    Oral

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Generic tamoxifen citrate tablets, from several manufacturers

    Oral

    The uses in each product's label.

    Source: DailyMed label, checked 25 Oct 2026

  • Nolvadex (tamoxifen citrate) tablets, discontinued in the US

    Oral

    Approved; Drugs@FDA lists it as Discontinued.

    Source: Drugs@FDA, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each marketed product above as "Prescription".

    Source: Drugs@FDA, checked 25 Oct 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add tamoxifen 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 the status label “FDA Approved”; the list above gives the detail by product.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
  • 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 tamoxifen or any other compound.

More sources

  • FDA, Drugs@FDA, checked 25 Oct 2026: product, route and marketing status for NDA 021807 (Soltamox), ANDA 074732 (generic tamoxifen citrate tablets, Mylan) and NDA 017970 (Nolvadex, discontinued).
  • FDA, Global Substance Registration System, Tamoxifen citrate, checked 25 Oct 2026: the names ICI-46474, Nolvadex and Soltamox.

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

Coming soon to the App Store

See planned pricing