Peptimes

Track dutasteride in Peptimes

Dutasteride is a synthetic 4-azasteroid compound and a 5-alpha-reductase inhibitor. It is the active ingredient in Avodart, FDA-approved prescription capsules, and one of the two active ingredients in Jalyn capsules. (Source: DailyMed label.)

Is dutasteride FDA-approved?

Yes, as specific products: Avodart and Jalyn capsules 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.

Dutasteride

Also: Avodart, GI198745

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.

  • Avodart (dutasteride) capsules

    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

  • Jalyn (dutasteride and tamsulosin hydrochloride) capsules

    Oral

    Symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

    Source: DailyMed label, checked 25 Oct 2026

  • Generic dutasteride capsules, from several manufacturers, with Avodart 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 dutasteride and tamsulosin hydrochloride capsules, from several manufacturers, with Jalyn 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 dutasteride 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 is investigational, not approved. Choose the one that matches each dose. Every product above is an oral capsule, and its US approval is for an enlarged prostate.
  • 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 dutasteride or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 021319 (Avodart) and NDA 022460 (Jalyn), checked 25 Oct 2026: product, route and marketing status, and the generic capsules listed as therapeutic equivalents.
  • FDA, Global Substance Registration System, Dutasteride, checked 25 Oct 2026: the code name GI-198745 (written GI198745 in the Peptimes Library).

Finasteride, dutasteride and minoxidil trackerWhat FDA status terms mean

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