← FDA Drug Approvals (Drugs@FDA)
RELEXXII
NDA · New Drug Application · Sponsor: OSMOTICA PHARM US · Approved 2022-06-23
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown