FDA — authorised 10 June 2005
- Application: NDA021793
- Marketing authorisation holder: MEDA PHARMS
- Local brand name: REGLAN ODT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA authorised Reglan ODT on 10 June 2005
Yes. FDA authorised it on 10 June 2005.
MEDA PHARMS holds the US marketing authorisation.