Methylphenidate
Sold as Daytrana, Cotempla Xr-Odt. Every branded application for this active ingredient, and 2 generic applications.
- First approved: Apr 6, 2006
- Branded applications: 4
- New uses approved: 1
- Complete response letters: 0
Applications
NDAs and BLAs for this ingredient, oldest first; each opens its full history| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Apr 6, 2006 | DaytranaNDA 21514 · TYPE 2/3 | Noven Pharms Inc | 26 | Marketed |
| Jun 19, 2017 | Cotempla Xr-OdtNDA 205489 · New dosage form | Neos Theraps Inc | 4 | Marketed |
| Jun 19, 2020 | MethylphenidateANDA 210924 | Actavis Elizabeth | 0 | Marketed |
| Mar 14, 2022 | MethylphenidateANDA 206497 | Mylan Tech Viatris | 3 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Drugs@FDA