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ARIDOL KIT

NDA · New Drug Application · Sponsor: PHARMAXIS EUROPE · Approved 2010-10-05

Drug application

FDA Application #

NDA022368

Application type

New Drug Application

Brand name

ARIDOL KIT

Generic name

MANNITOL

Active ingredients

MANNITOL

Dosage form

POWDER

Route

INHALATION

Marketing status

Prescription

Sponsor

PHARMAXIS EUROPE

Manufacturer

Methapharm, Inc.

First approval

2010-10-05

Source

Authoritative

Drugs@FDA application overview

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