FDA
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Status: approved
🇺🇸 Mebutina in United States
Mebutina (MEBUTAMATE) regulatory status in United States.
Marketing authorisations
FDA
- Application: NDA017374
- Marketing authorisation holder: MEDPOINTE PHARM HLC
- Local brand name: DORMATE
- Indication: TABLET — ORAL
- Status: approved
Mebutina in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Mebutina approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Mebutina in United States?
MEDPOINTE PHARM HLC holds the US marketing authorisation.