FDA — authorised 14 June 2006
- Application: NDA021479
- Marketing authorisation holder: BAUSCH
- Local brand name: ZELAPAR
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
🇺🇸 Zelapar in United States
FDA authorised Zelapar on 14 June 2006
Marketing authorisations
FDA
- Status: approved
Other Neuroscience approved in United States
Frequently asked questions
Is Zelapar approved in United States?
Yes. FDA authorised it on 14 June 2006; FDA has authorised it.
Who is the marketing authorisation holder for Zelapar in United States?
BAUSCH holds the US marketing authorisation.