# EXONDYS 51
> **NDA206488** · New Drug Application · Sponsor: SAREPTA THERAPS INC · Approved 2016-09-19
## Drug
- **FDA Application Number:** NDA206488
- **Application type:** New Drug Application
- **Brand name:** EXONDYS 51
- **Generic name:** ETEPLIRSEN
- **Active ingredients:** ETEPLIRSEN
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** SAREPTA THERAPS INC
- **Manufacturer:** Sarepta Therapeutics, Inc.
- **First approval:** 2016-09-19
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206488)
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