FDA — authorised 20 July 2018
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
🇺🇸 Krintafel in United States
FDA authorised Krintafel on 20 July 2018
Marketing authorisations
FDA — authorised 20 July 2018
- Application: NDA210795
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: KRINTAFEL
- Indication: TABLET — ORAL
- Status: approved
Krintafel in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Krintafel approved in United States?
Yes. FDA authorised it on 20 July 2018; FDA authorised it on 20 July 2018.
Who is the marketing authorisation holder for Krintafel in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.