FDA — authorised 2 April 1953
- Status: approved
🇺🇸 Pro-Banthine in United States
FDA authorised Pro-Banthine on 2 April 1953
Marketing authorisations
FDA — authorised 2 April 1953
- Application: NDA008732
- Marketing authorisation holder: SHIRE
- Local brand name: PRO-BANTHINE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: NDA008843
- Marketing authorisation holder: GD SEARLE LLC
- Local brand name: PRO-BANTHINE
- Indication: INJECTABLE — INJECTION
- Status: approved
Pro-Banthine in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Gastroenterology approved in United States
Frequently asked questions
Is Pro-Banthine approved in United States?
Yes. FDA authorised it on 2 April 1953; FDA authorised it on 2 April 1953; FDA has authorised it.
Who is the marketing authorisation holder for Pro-Banthine in United States?
Marketing authorisation holder not available in our data.