FDA — authorised 3 July 1951
- Marketing authorisation holder: SHIRE
- Status: approved
🇺🇸 Banthine in United States
FDA authorised Banthine on 3 July 1951
Marketing authorisations
FDA — authorised 3 July 1951
- Application: NDA007390
- Marketing authorisation holder: SHIRE
- Local brand name: BANTHINE
- Indication: TABLET — ORAL
- Status: approved
Banthine 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 Banthine approved in United States?
Yes. FDA authorised it on 3 July 1951; FDA authorised it on 3 July 1951.
Who is the marketing authorisation holder for Banthine in United States?
SHIRE holds the US marketing authorisation.