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ARIKAYCE KIT

NDA · New Drug Application · Sponsor: INSMED INC · Approved 2018-09-28

Drug application

FDA Application #

NDA207356

Application type

New Drug Application

Brand name

ARIKAYCE KIT

Generic name

AMIKACIN

Active ingredients

AMIKACIN SULFATE

Dosage form

SUSPENSION, LIPOSOMAL

Route

INHALATION

Marketing status

Prescription

Sponsor

INSMED INC

Manufacturer

Insmed Incorporated

First approval

2018-09-28

Source

Authoritative

Drugs@FDA application overview

Machine

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