FDA — authorised 5 July 1960
- Status: approved
🇺🇸 Ismelin in United States
FDA authorised Ismelin on 5 July 1960
Marketing authorisations
FDA — authorised 5 July 1960
- Application: NDA012329
- Marketing authorisation holder: NOVARTIS
- Local brand name: ISMELIN
- Indication: TABLET — ORAL
- Status: approved
Ismelin 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 Ismelin approved in United States?
Yes. FDA authorised it on 5 July 1960; FDA authorised it on 5 July 1960.
Who is the marketing authorisation holder for Ismelin in United States?
Marketing authorisation holder not available in our data.