← FDA Drug Approvals (Drugs@FDA)
OSMOLEX ER
NDA · New Drug Application · Sponsor: SUPERNUS PHARMS · Approved 2018-02-16
Drug application
- FDA Application #
NDA209410- Application type
- New Drug Application
- Brand name
- OSMOLEX ER
- Generic name
- Amantadine Hydrochloride
- Active ingredients
- AMANTADINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- SUPERNUS PHARMS
- First approval
- 2018-02-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown