Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022260

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VELETRI (EPOPROSTENOL SODIUM)
EQ 0.5MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: EPOPROSTENOL SODIUM
Proprietary Name: VELETRI
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 0.5MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP2
Application Number: N022260
Product Number: 002
Approval Date: Jun 28, 2012
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VELETRI (EPOPROSTENOL SODIUM)
EQ 1.5MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: EPOPROSTENOL SODIUM
Proprietary Name: VELETRI
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 1.5MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP2
Application Number: N022260
Product Number: 001
Approval Date: Jun 27, 2008
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information