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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022368


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NDA 022368 describes ARIDOL KIT, which is a drug marketed by Pharmaxis Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the ARIDOL KIT profile page.

The generic ingredient in ARIDOL KIT is mannitol. There are eighteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the mannitol profile page.
Summary for 022368
Tradename:ARIDOL KIT
Applicant:Pharmaxis Ltd
Ingredient:mannitol
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022368
Suppliers and Packaging for NDA: 022368
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARIDOL KIT mannitol POWDER;INHALATION 022368 NDA Methapharm, Inc. 67850-552 67850-552-01 1 KIT in 1 KIT (67850-552-01) * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT * 1 POWDER in 1 CAPSULE * 1 POWDER in 1 KIT

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrengthN/A,5MG,10MG,20MG,40MG
Approval Date:Oct 5, 2010TE:RLD:Yes

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