# RELEXXII
> **NDA216117** · New Drug Application · Sponsor: OSMOTICA PHARM US · Approved 2022-06-23
## Drug
- **FDA Application Number:** NDA216117
- **Application type:** New Drug Application
- **Brand name:** RELEXXII
- **Generic name:** METHYLPHENIDATE HYDROCHLORIDE
- **Active ingredients:** METHYLPHENIDATE HYDROCHLORIDE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** OSMOTICA PHARM US
- **Manufacturer:** Trigen Laboratories, LLC
- **First approval:** 2022-06-23
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216117)
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