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Details for New Drug Application (NDA): 021779

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NDA 021779 describes VENTAVIS, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the VENTAVIS profile page.

The generic ingredient in VENTAVIS is iloprost. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iloprost profile page.

Summary for 021779

Tradename:	VENTAVIS
Applicant:	Actelion Pharms Ltd
Ingredient:	iloprost
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021779

Ingredient-type

Prostaglandins I

Medical Subject Heading (MeSH) Categories for 021779

Platelet Aggregation Inhibitors

Vasodilator Agents

Suppliers and Packaging for NDA: 021779

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VENTAVIS	iloprost	SOLUTION;INHALATION	021779	NDA	Actelion Pharmaceuticals US, Inc.	66215-302	66215-302-30	30 AMPULE in 1 CARTON (66215-302-30) > 1 mL in 1 AMPULE (66215-302-00)
VENTAVIS	iloprost	SOLUTION;INHALATION	021779	NDA	Actelion Pharmaceuticals US, Inc.	66215-303	66215-303-30	30 AMPULE in 1 CARTON (66215-303-30) > 1 mL in 1 AMPULE (66215-303-00)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INHALATION			Strength	20MCG/2ML (10MCG/ML)
Approval Date:	Dec 29, 2004	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	10MCG/ML (10MCG/ML)
Approval Date:	Dec 8, 2005	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INHALATION			Strength	20MCG/ML (20MCG/ML)
Approval Date:	Aug 7, 2009	TE:		RLD:	Yes

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