FdaApplication
NDA 209531
Identifiers
- fda_app_no: NDA209531
Properties
| Property | Value |
|---|---|
| applicant_name | BIOGEN INC |
| application_type | NDA |
| approval_date | 2016-12-23 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SPINRAZA | NUSINERSEN SODIUM | EQ 28MG BASE/5ML (EQ 5.6MG BASE/ML) | SOLUTION;INTRATHECAL |
| SPINRAZA | NUSINERSEN SODIUM | EQ 50MG BASE/5ML (EQ 10MG BASE/ML) | SOLUTION;INTRATHECAL |
| SPINRAZA | NUSINERSEN SODIUM | EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML) | SOLUTION;INTRATHECAL |
3 products