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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

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
Medical Subject Heading (MeSH) Categories for 021779
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:DISCNDosage:SOLUTION;INHALATIONStrength20MCG/2ML (10MCG/ML)
Approval Date:Dec 29, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength10MCG/ML (10MCG/ML)
Approval Date:Dec 8, 2005TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INHALATIONStrength20MCG/ML (20MCG/ML)
Approval Date:Aug 7, 2009TE:RLD:Yes

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