FDA — authorised 30 October 2003
- Application: NDA021589
- Marketing authorisation holder: UCB INC
- Local brand name: KEMSTRO
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
🇺🇸 Kemstro in United States
FDA authorised Kemstro on 30 October 2003
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Kemstro approved in United States?
Yes. FDA authorised it on 30 October 2003; FDA has authorised it.
Who is the marketing authorisation holder for Kemstro in United States?
UCB INC holds the US marketing authorisation.