FDA — authorised 7 February 1979
- Application: NDA017862
- Marketing authorisation holder: HIKMA
- Local brand name: REGLAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Metclopramide in United States
FDA authorised Metclopramide on 7 February 1979
Marketing authorisations
FDA — authorised 30 December 1980
- Application: NDA017854
- Marketing authorisation holder: ANI PHARMS
- Local brand name: REGLAN
- Indication: TABLET — ORAL
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Metclopramide approved in United States?
Yes. FDA authorised it on 7 February 1979; FDA authorised it on 30 December 1980.
Who is the marketing authorisation holder for Metclopramide in United States?
HIKMA holds the US marketing authorisation.