# COTEMPLA XR-ODT
> **NDA205489** · New Drug Application · Sponsor: NEOS THERAPS INC · Approved 2017-06-19
## Drug
- **FDA Application Number:** NDA205489
- **Application type:** New Drug Application
- **Brand name:** COTEMPLA XR-ODT
- **Generic name:** METHYLPHENIDATE
- **Active ingredients:** METHYLPHENIDATE
- **Dosage form:** TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NEOS THERAPS INC
- **Manufacturer:** Neos Therapeutics Brands, LLC
- **First approval:** 2017-06-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205489)
---
*AI Analytics · CC0 1.0*