FDA — authorised 9 May 2000
- Application: ANDA075629
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHYLIN ER
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Long acting methylphenidate in United States
FDA authorised Long acting methylphenidate on 9 May 2000
Marketing authorisation
Other Neurology; Psychiatry approved in United States
Frequently asked questions
Is Long acting methylphenidate approved in United States?
Yes. FDA authorised it on 9 May 2000.
Who is the marketing authorisation holder for Long acting methylphenidate in United States?
SPECGX LLC holds the US marketing authorisation.