🇺🇸 Metabarbital in United States

Metabarbital (METHARBITAL) regulatory status in United States.

Marketing authorisations

FDA

  • Marketing authorisation holder: ABBVIE
  • Status: approved

FDA

  • Application: NDA008322
  • Marketing authorisation holder: ABBVIE
  • Local brand name: GEMONIL
  • Indication: TABLET — ORAL
  • Status: approved

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Metabarbital in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neuroscience approved in United States

Frequently asked questions

Is Metabarbital approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for Metabarbital in United States?

ABBVIE holds the US marketing authorisation.