Is galantamine FDA-approved?

Yes, as specific products: generic galantamine tablets, oral solution and extended-release capsules are FDA-approved for the use in their labels. The Razadyne brands are discontinued.

Checked 1 Nov 2026. The sources are below.

Galantamine

Also: galanthamine, galantamine hydrobromide, Razadyne

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Oral
Updated
1 Nov 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.

  • Galantamine tablets (generic, from several manufacturers)

    Oral

    "Mild to moderate dementia of the Alzheimer's type".

    Source: DailyMed label, checked 1 Nov 2026

  • Galantamine oral solution (generic)

    Oral

    "Mild to moderate dementia of the Alzheimer's type".

    Source: DailyMed label, checked 1 Nov 2026

  • Galantamine extended-release capsules (generic, from several manufacturers)

    Oral

    "Mild to moderate dementia of the Alzheimer's type".

    Source: DailyMed label, checked 1 Nov 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In humans

    The FDA label describes 5 randomised, double-blind, placebo-controlled trials in people with probable Alzheimer's disease as the evidence for galantamine's approval, and states there is no evidence that it alters the course of the underlying disease.

    Source: FDA label, galantamine tablets (DailyMed), checked 1 Nov 2026

How to track it in Peptimes

Add galantamine 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 entries above give the products it applies to.

  • 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 peptide tracker app page.

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

More sources

  • FDA, Drugs@FDA: NDA 021169 (Razadyne tablets), NDA 021224 (Razadyne oral solution) and NDA 021615 (Razadyne ER), checked 1 Nov 2026: all listed as discontinued. Generic galantamine tablets, oral solution and extended-release capsules are listed as “Prescription”.
  • National Library of Medicine, DailyMed, galantamine labels, one generic’s each, checked 1 Nov 2026: tablets, oral solution and extended-release capsules: section 1 (indications) of each, and sections 11 (description) and 14 (clinical studies) of the tablets label.
  • FDA, Global Substance Registration System, Galantamine, checked 1 Nov 2026: the name galanthamine.

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

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