Is finasteride FDA-approved?

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

Checked 25 Oct 2026. The sources are below.

Finasteride

Also: Proscar, Propecia, MK-906

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

  • Proscar (finasteride) tablets

    Oral

    Symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, in the ways the label defines.

    Source: DailyMed label, checked 25 Oct 2026

  • Propecia (finasteride) tablets

    Oral

    The use in its label, in men only. The label says it is not indicated for use in women.

    Source: DailyMed label, checked 25 Oct 2026

  • Generic finasteride tablets, from several manufacturers, with Proscar as the reference product

    Oral

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

    Source: Drugs@FDA, checked 25 Oct 2026

  • Generic finasteride tablets, from several manufacturers, with Propecia as the reference product

    Oral

    As stated on each product's label (approved through ANDAs).

    Source: Drugs@FDA, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each 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 finasteride 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.

  • Routes: oral; topical only as a compounded product in the US. Choose the one that matches each dose. Every product above is an oral tablet: Drugs@FDA lists no topical finasteride product, and a compounded product doesn’t share an approved product’s approval.
  • Logging: the amount you took, the route and how you feel.
  • No injection sites: oral and topical doses never carry an injection site.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the finasteride, dutasteride and minoxidil tracker page.

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

More sources

  • FDA, Drugs@FDA: NDA 020180 (Proscar) and NDA 020788 (Propecia), checked 25 Oct 2026: product, route and marketing status, and the generic tablets listed as therapeutic equivalents.
  • FDA, Global Substance Registration System, Finasteride, checked 25 Oct 2026: the code name MK-906.

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

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