FdaApplication
NDA 206488
Identifiers
- fda_app_no: NDA206488
Properties
| Property | Value |
|---|---|
| applicant_name | SAREPTA THERAPEUTICS INC |
| application_type | NDA |
| approval_date | 2016-09-19 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| EXONDYS 51 | ETEPLIRSEN | 100MG/2ML (50MG/ML) | SOLUTION;INTRAVENOUS |
| EXONDYS 51 | ETEPLIRSEN | 500MG/10ML (50MG/ML) | SOLUTION;INTRAVENOUS |
2 products