FDA — authorised 1 May 1956
- Application: NDA010155
- Marketing authorisation holder: SANOFI AVENTIS US
- Local brand name: MYTELASE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Mytelase in United States
FDA authorised Mytelase on 1 May 1956
Marketing authorisations
FDA
- Status: approved
Mytelase in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Mytelase approved in United States?
Yes. FDA authorised it on 1 May 1956; FDA has authorised it.
Who is the marketing authorisation holder for Mytelase in United States?
SANOFI AVENTIS US holds the US marketing authorisation.