Osmolex Er

NDA 209410, held by Supernus Pharms. Amantadine Hydrochloride.

As of Nov 14, 2026, NDA 209410 (Osmolex Er), held by Supernus Pharms, was first approved by FDA on Feb 16, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 16, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Feb 16, 2018	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

4 strengths and forms


Osmolex ErEQ 129MG BASE · tablet, extended release;oral	Amantadine Hydrochloride	DiscontinuedReference drug
Osmolex ErEQ 193MG BASE · tablet, extended release;oral	Amantadine Hydrochloride	DiscontinuedReference drug
Osmolex ErEQ 258MG BASE · tablet, extended release;oral	Amantadine Hydrochloride	DiscontinuedReference drug
Osmolex ErEQ 161MG BASE · tablet, extended release;oral	Amantadine Hydrochloride	DiscontinuedReference drug

All 2 submissions, including labeling and manufacturing supplements


Jul 10, 2025	Supplement 9Labeling · Standard review	Approved	Letter Label
Feb 16, 2018	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 209410
Drugs@FDA: Overview at FDA
Company: Supernus Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters