FDA — authorised 30 April 2010
- Application: NDA022511
- Marketing authorisation holder: HORIZON
- Local brand name: VIMOVO
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 PN400 in United States
FDA authorised PN400 on 30 April 2010
Marketing authorisation
Frequently asked questions
Is PN400 approved in United States?
Yes. FDA authorised it on 30 April 2010.
Who is the marketing authorisation holder for PN400 in United States?
HORIZON holds the US marketing authorisation.