FDA — authorised 8 April 2013
- Application: NDA021876
- Marketing authorisation holder: DUCHESNAY
- Local brand name: DICLEGIS
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
🇺🇸 Diclegis in United States
FDA authorised Diclegis on 8 April 2013
Marketing authorisations
FDA
- Status: approved
Diclegis in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Diclegis approved in United States?
Yes. FDA authorised it on 8 April 2013; FDA has authorised it.
Who is the marketing authorisation holder for Diclegis in United States?
DUCHESNAY holds the US marketing authorisation.