FDA Approved Products
| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|
| 213026 | NDA | SAREPTA THERAPS INC | | 001 | AMONDYS 45 | SOLUTION;INTRAVENOUS | 100MG/2ML (50MG/ML) | CASIMERSEN | 2021-02-25 | Prescription | Yes |
| 211970 | NDA | SAREPTA THERAPS INC | | 001 | VYONDYS 53 | SOLUTION;INTRAVENOUS | 100MG/2ML (50MG/ML) | GOLODIRSEN | 2019-12-12 | Prescription | Yes |
| 206488 | NDA | SAREPTA THERAPS INC | | 001 | EXONDYS 51 | SOLUTION;INTRAVENOUS | 100MG/2ML (50MG/ML) | ETEPLIRSEN | 2016-09-19 | Prescription | Yes |
| 002 | EXONDYS 51 | SOLUTION;INTRAVENOUS | 500MG/10ML (50MG/ML) | ETEPLIRSEN | 2016-09-19 | Prescription | Yes |