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SPINRAZA

NDA · New Drug Application · Sponsor: BIOGEN IDEC · Approved 2016-12-23

Drug application

FDA Application #

NDA209531

Application type

New Drug Application

Brand name

SPINRAZA

Generic name

NUSINERSEN

Active ingredients

NUSINERSEN SODIUM

Dosage form

SOLUTION

Route

INTRATHECAL

Marketing status

Prescription

Sponsor

BIOGEN IDEC

Manufacturer

Biogen Inc.

First approval

2016-12-23

Source

Authoritative

Drugs@FDA application overview

Machine

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