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AMONDYS 45

NDA · New Drug Application · Sponsor: SAREPTA THERAPS INC · Approved 2021-02-25

Drug application

FDA Application #

NDA213026

Application type

New Drug Application

Brand name

AMONDYS 45

Generic name

CASIMERSEN

Active ingredients

CASIMERSEN

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

SAREPTA THERAPS INC

Manufacturer

Sarepta Therapeutics, Inc.

First approval

2021-02-25

Source

Authoritative

Drugs@FDA application overview

Machine

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