FDA — authorised 7 February 1979
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Status: approved
🇺🇸 Reglan in United States
FDA authorised Reglan on 7 February 1979
Marketing authorisations
FDA — authorised 27 July 1983
- Application: NDA017854
- Marketing authorisation holder: ANI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 24 November 1999
- Application: ANDA073135
- Marketing authorisation holder: TEVA PHARMS USA
- Indication: Labeling
- Status: approved
FDA — authorised 7 January 2000
- Application: ANDA073118
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 12 June 2008
- Application: ANDA078807
- Marketing authorisation holder: IPCA LABS LTD
- Status: approved
FDA — authorised 30 October 2019
- Application: ANDA091392
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- 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 Metabolic approved in United States
Frequently asked questions
Is Reglan approved in United States?
Yes. FDA authorised it on 7 February 1979; FDA authorised it on 27 July 1983; FDA authorised it on 24 November 1999.
Who is the marketing authorisation holder for Reglan in United States?
BAXTER HLTHCARE CORP holds the US marketing authorisation.