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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. Additional details are available on the VELETRI profile page.

The generic ingredient in VELETRI is epoprostenol sodium. There are six 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 NDA: 022260

Tradename:
VELETRI
Applicant:
Actelion Pharms Ltd
Ingredient:
epoprostenol sodium
Patents:2
Formulation / Manufacturing:see details

Pharmacology for NDA: 022260

Ingredient-typeProstaglandins I
Physiological EffectVasodilation

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. 66215-401 66215-401-01 1 VIAL in 1 CARTON (66215-401-01) > 10 mL in 1 VIAL
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1.5MG BASE/VIAL
Approval Date:Jun 27, 2008TE:RLD:Yes
Patent:8,318,802Patent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:8,598,227Patent Expiration:Feb 2, 2027Product Flag?Substance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.5MG BASE/VIAL
Approval Date:Jun 28, 2012TE:RLD:No
Patent:8,318,802Patent Expiration:Mar 15, 2027Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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