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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 022260


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NDA 022260 describes VELETRI, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the VELETRI profile page.

The generic ingredient in VELETRI is epoprostenol sodium. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the epoprostenol sodium profile page.
Summary for 022260
Tradename:VELETRI
Applicant:Actelion Pharms Ltd
Ingredient:epoprostenol sodium
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 022260
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 022260
Suppliers and Packaging for NDA: 022260
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260 NDA Actelion Pharmaceuticals US, Inc. 66215-402 66215-402-01 1 VIAL in 1 CARTON (66215-402-01) > 10 mL in 1 VIAL
VELETRI epoprostenol sodium INJECTABLE;INJECTION 022260 NDA Actelion Pharmaceuticals US, Inc. 66215-403 66215-403-01 1 VIAL in 1 CARTON (66215-403-01) > 10 mL in 1 VIAL
Paragraph IV (Patent) Challenges for 022260
Tradename Dosage Ingredient NDA Submissiondate
VELETRI INJECTABLE;INJECTION epoprostenol sodium 022260 2017-03-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5MG BASE/VIAL
Approval Date:Jun 27, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Feb 2, 2027Product Flag?Substance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/VIAL
Approval Date:Jun 28, 2012TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?

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