FDA — authorised 19 June 2017
- Application: NDA205489
- Marketing authorisation holder: NEOS THERAPS INC
- Local brand name: COTEMPLA XR-ODT
- Indication: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Concerta EG formulation in United States
FDA authorised Concerta EG formulation on 19 June 2017
Marketing authorisations
FDA — authorised 19 June 2020
- Application: ANDA210924
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Local brand name: METHYLPHENIDATE
- Indication: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 March 2022
- Application: ANDA206497
- Marketing authorisation holder: MYLAN TECH VIATRIS
- Local brand name: METHYLPHENIDATE
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
Other Neurology approved in United States
Frequently asked questions
Is Concerta EG formulation approved in United States?
Yes. FDA authorised it on 19 June 2017; FDA authorised it on 19 June 2020; FDA authorised it on 14 March 2022.
Who is the marketing authorisation holder for Concerta EG formulation in United States?
NEOS THERAPS INC holds the US marketing authorisation.