FdaApplication
NDA 211371
Identifiers
- fda_app_no: NDA211371
Properties
| Property | Value |
|---|---|
| applicant_name | SAGE THERAPEUTICS LLC A WHOLLY OWNED SUB OF SUPERNUS PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2019-06-17 |
Products (1)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| ZULRESSO | BREXANOLONE | 100MG/20ML (5MG/ML) | SOLUTION;INTRAVENOUS |
1 product