FdaApplication
NDA 209410
Identifiers
- fda_app_no: NDA209410
Properties
| Property | Value |
|---|---|
| applicant_name | SUPERNUS PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2018-02-16 |
Products (4)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| OSMOLEX ER | AMANTADINE HYDROCHLORIDE | EQ 258MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| OSMOLEX ER | AMANTADINE HYDROCHLORIDE | EQ 161MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| OSMOLEX ER | AMANTADINE HYDROCHLORIDE | EQ 193MG BASE | TABLET, EXTENDED RELEASE;ORAL |
| OSMOLEX ER | AMANTADINE HYDROCHLORIDE | EQ 129MG BASE | TABLET, EXTENDED RELEASE;ORAL |
4 products