Details for New Drug Application (NDA): 022368

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NDA 022368 describes ARIDOL KIT, which is a drug marketed by Pharmaxis Europe 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. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.

Summary for 022368

Tradename:	ARIDOL KIT
Applicant:	Pharmaxis Europe
Ingredient:	mannitol
Patents:	0

Medical Subject Heading (MeSH) Categories for 022368

Diuretics, Osmotic
Sweetening Agents

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 CAPSULE * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT * 1 POWDER in 1 KIT

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	N/A,5MG,10MG,20MG,40MG
Approval Date:	Oct 5, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 022368

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmaxis Europe	ARIDOL KIT	mannitol	POWDER;INHALATION	022368-001	Oct 5, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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