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EXONDYS 51

NDA · New Drug Application · Sponsor: SAREPTA THERAPS INC · Approved 2016-09-19

Drug application

FDA Application #

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

Authoritative

Drugs@FDA application overview

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