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VYONDYS 53

NDA · New Drug Application · Sponsor: SAREPTA THERAPS INC · Approved 2019-12-12

Drug application

FDA Application #

NDA211970

Application type

New Drug Application

Brand name

VYONDYS 53

Generic name

GOLODIRSEN

Active ingredients

GOLODIRSEN

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

SAREPTA THERAPS INC

Manufacturer

Sarepta Therapeutics, Inc.

First approval

2019-12-12

Source

Authoritative

Drugs@FDA application overview

Machine

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