Composition
- Active ingredients
- AMANTADINE HYDROCHLORIDE EQ 193MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- AMANTADINE HYDROCHLORIDE EQ 161MG BASE · Tablet, extended releaseNDA209410-004 · Discontinued
- AMANTADINE HYDROCHLORIDE EQ 193MG BASE · Tablet, extended releaseThis page
- AMANTADINE HYDROCHLORIDE EQ 258MG BASE · Tablet, extended releaseNDA209410-003 · Discontinued
- AMANTADINE HYDROCHLORIDE EQ 129MG BASE · Tablet, extended releaseNDA209410-001 · Discontinued
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application NDA209410.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Osmolex ER
- Active substance
- amantadine hydrochloride
- Route
- Oral
- Dosage form
- Tablet, extended release
- Applicant
- Supernus Pharms
- Status
- Discontinued
- FDA approval
- 16 Feb 2018
- Application
- NDA209410-002