Is anastrozole FDA-approved?

Yes, as specific products: Arimidex tablets and generic anastrozole tablets are FDA-approved for the uses in their labels, and they're prescription only.

Checked 25 Oct 2026. The sources are below.

Anastrozole

Also: ZD1033, ICI-D1033, Arimidex

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.

  • Arimidex (anastrozole) tablets

    Oral

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Generic anastrozole tablets, from several manufacturers

    Oral

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

    Source: Drugs@FDA, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists Arimidex and each marketed generic 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 anastrozole 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 anastrozole or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 020541 (Arimidex), checked 25 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Anastrozole, checked 25 Oct 2026: the code names ZD1033 and ICI-D1033.

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