FDA — authorised 5 April 1967
- Application: NDA016033
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: VONTROL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 DIPHENIDOL HYDROCHLORIDE in United States
FDA authorised DIPHENIDOL HYDROCHLORIDE on 5 April 1967
Marketing authorisations
FDA
- Status: approved
DIPHENIDOL HYDROCHLORIDE 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 DIPHENIDOL HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 5 April 1967; FDA has authorised it.
Who is the marketing authorisation holder for DIPHENIDOL HYDROCHLORIDE in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.