Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021779

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VENTAVIS (ILOPROST)
10MCG/ML (10MCG/ML)
Marketing Status: Discontinued

Active Ingredient: ILOPROST
Proprietary Name: VENTAVIS
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: 10MCG/ML (10MCG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021779
Product Number: 002
Approval Date: Dec 8, 2005
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

VENTAVIS (ILOPROST)
20MCG/ML (20MCG/ML)
Marketing Status: Discontinued

Active Ingredient: ILOPROST
Proprietary Name: VENTAVIS
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: 20MCG/ML (20MCG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021779
Product Number: 003
Approval Date: Aug 7, 2009
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

VENTAVIS (ILOPROST)
20MCG/2ML (10MCG/ML)
Marketing Status: Discontinued

Active Ingredient: ILOPROST
Proprietary Name: VENTAVIS
Dosage Form; Route of Administration: SOLUTION; INHALATION
Strength: 20MCG/2ML (10MCG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N021779
Product Number: 001
Approval Date: Dec 29, 2004
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Discontinued
Patent and Exclusivity Information