FDA — authorised 19 December 2002
- Application: NDA021419
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHYLIN
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Short Acting Methylphenidate in United States
FDA authorised Short Acting Methylphenidate on 19 December 2002
Marketing authorisations
FDA — authorised 15 April 2003
- Application: NDA021475
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHYLIN
- Indication: TABLET, CHEWABLE — ORAL
- Status: approved
Other Neurology; Psychiatry approved in United States
Frequently asked questions
Is Short Acting Methylphenidate approved in United States?
Yes. FDA authorised it on 19 December 2002; FDA authorised it on 15 April 2003.
Who is the marketing authorisation holder for Short Acting Methylphenidate in United States?
SPECGX LLC holds the US marketing authorisation.