FDA — authorised 30 December 1980
- Application: NDA017854
- Marketing authorisation holder: ANI PHARMS
- Status: supplemented
🇺🇸 Reglan in United States
FDA authorised Reglan on 30 December 1980
Marketing authorisations
FDA — authorised 20 December 2013
- Application: ANDA204756
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: METOCLOPRAMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Reglan 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 Reglan approved in United States?
Yes. FDA authorised it on 30 December 1980; FDA authorised it on 20 December 2013; FDA has authorised it.
Who is the marketing authorisation holder for Reglan in United States?
ANI PHARMS holds the US marketing authorisation.