FDA — authorised 11 May 1950
- Marketing authorisation holder: FOREST LABS INC
- Status: approved
🇺🇸 Bentyl in United States
FDA authorised Bentyl on 11 May 1950
Marketing authorisations
FDA — authorised 11 May 1950
- Application: NDA007409
- Marketing authorisation holder: ALLERGAN
- Local brand name: BENTYL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 1951
- Application: NDA007961
- Marketing authorisation holder: APTALIS PHARMA US
- Local brand name: BENTYL
- Indication: SYRUP — ORAL
- Status: approved
Bentyl 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 Bentyl approved in United States?
Yes. FDA authorised it on 11 May 1950; FDA authorised it on 11 May 1950; FDA authorised it on 30 April 1951.
Who is the marketing authorisation holder for Bentyl in United States?
FOREST LABS INC holds the US marketing authorisation.