FDA — authorised 2 April 2021
- Application: NDA211964
- Marketing authorisation holder: SUPERNUS PHARMS
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 VILOXAZINE HYDROCHLORIDE in United States
FDA authorised VILOXAZINE HYDROCHLORIDE on 2 April 2021
Marketing authorisations
FDA
- Application: ANDA220326
- Marketing authorisation holder: APPCO PHARMA LLC
- Local brand name: VILOXAZINE HYDROCHLORIDE
- Indication: CAPSULE, EXTENDED RELEASE
- Status: approved
VILOXAZINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is VILOXAZINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 2 April 2021; FDA has authorised it.
Who is the marketing authorisation holder for VILOXAZINE HYDROCHLORIDE in United States?
SUPERNUS PHARMS holds the US marketing authorisation.