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FDA NDA · NDA209410

OSMOLEX ER

Sponsor: SUPERNUS PHARMS

APPLICATION
NDA209410
TYPE
NDA
ORIGINAL APPROVAL
2018-02-16
LATEST ACTION
2025-07-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

OSMOLEX ER · ReferenceDiscontinued
AMANTADINE HYDROCHLORIDE EQ 161MG BASE · TABLET, EXTENDED RELEASE · ORAL
OSMOLEX ER · ReferenceDiscontinued
AMANTADINE HYDROCHLORIDE EQ 193MG BASE · TABLET, EXTENDED RELEASE · ORAL
OSMOLEX ER · ReferenceDiscontinued
AMANTADINE HYDROCHLORIDE EQ 258MG BASE · TABLET, EXTENDED RELEASE · ORAL
OSMOLEX ER · ReferenceDiscontinued
AMANTADINE HYDROCHLORIDE EQ 129MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-07-10Labeling · Supplement 9 · standard — Letter ↗AP
2018-02-16Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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