Is clomiphene FDA-approved?

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

Checked 25 Oct 2026. The sources are below.

Clomiphene

Also: clomiphene citrate, clomifene, clomifene citrate, MRL-41, MER-41, Clomid, Milophene, Serophene

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.

  • Clomid (clomiphene citrate) tablets

    Oral

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Milophene (clomiphene citrate) tablets

    Oral

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Generic clomiphene citrate 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 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 clomiphene 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 clomiphene or any other compound.

More sources

  • FDA, Drugs@FDA, checked 25 Oct 2026: product, route and marketing status for ANDA 075528 (Clomid, Cosette) and ANDA 072196 (Milophene). The original Clomid application, NDA 016131, and Serophene are listed as discontinued.
  • FDA, Global Substance Registration System, Clomiphene citrate, checked 25 Oct 2026: the names clomifene citrate, MRL-41 and MER-41.

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

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