FDA — authorised 5 December 1955
- Application: NDA010187
- Marketing authorisation holder: SANDOZ
- Local brand name: RITALIN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ritalin in United States
FDA authorised Ritalin on 5 December 1955
Marketing authorisations
FDA — authorised 6 May 2013
- Application: NDA021259
- Marketing authorisation holder: AYTU BIOPHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 25 February 2015
- Application: ANDA204115
- Marketing authorisation holder: NOVEL LABS INC
- Status: approved
FDA — authorised 28 October 2016
- Application: ANDA202608
- Marketing authorisation holder: SPECGX LLC
- Indication: Labeling
- Status: approved
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
FDA — authorised 6 September 2022
- Application: ANDA091601
- Marketing authorisation holder: TRIS PHARMA INC
- Indication: Labeling
- Status: approved
FDA — authorised 12 September 2023
- Application: ANDA210139
- Marketing authorisation holder: HIBROW HLTHCARE
- Indication: Labeling
- Status: approved
Ritalin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Ritalin approved in United States?
Yes. FDA authorised it on 5 December 1955; FDA authorised it on 6 May 2013; FDA authorised it on 25 February 2015.
Who is the marketing authorisation holder for Ritalin in United States?
SANDOZ holds the US marketing authorisation.