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WAINUA (AUTOINJECTOR)

NDA · New Drug Application · Sponsor: ASTRAZENECA AB · Approved 2023-12-21

Drug application

FDA Application #

NDA217388

Application type

New Drug Application

Brand name

WAINUA (AUTOINJECTOR)

Generic name

EPLONTERSEN

Active ingredients

EPLONTERSEN SODIUM

Dosage form

SOLUTION

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

ASTRAZENECA AB

Manufacturer

AstraZeneca Pharmaceuticals LP

First approval

2023-12-21

Source

Authoritative

Drugs@FDA application overview

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