FDA — authorised 1 August 2000
- Application: NDA021121
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: CONCERTA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Osmotic Release Methylphenidate in United States
FDA authorised Osmotic Release Methylphenidate on 1 August 2000
Marketing authorisations
FDA
- Status: approved
Osmotic Release Methylphenidate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Osmotic Release Methylphenidate approved in United States?
Yes. FDA authorised it on 1 August 2000; FDA has authorised it.
Who is the marketing authorisation holder for Osmotic Release Methylphenidate in United States?
JANSSEN PHARMS holds the US marketing authorisation.