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Generated: August 16, 2017

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 three 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 NDA: 021779

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 021779

Ingredient-typeProstaglandins I

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)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INHALATIONStrength20MCG/2ML (10MCG/ML)
Approval Date:Dec 29, 2004TE:RLD:No

Summary for product number 002

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

Summary 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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