FDA.reportPublic FDA data

Application 022260

Type
NDA
Sponsor
ACTELION PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VELETRIEPOPROSTENOL SODIUMINJECTABLE;INJECTIONEQ 1.5MG BASE/VIALYesYes
002VELETRIEPOPROSTENOL SODIUMINJECTABLE;INJECTIONEQ 0.5MG BASE/VIALYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66215-402VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-402VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-402VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-402VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-402VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-402VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-402VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-403VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-403VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-403VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-403VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-403VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-403VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent
66215-403VeletriepoprostenolActelion Pharmaceuticals US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65021SUPPL2020-10-23
64984SUPPL2020-10-23
56882SUPPL2018-12-20
56738SUPPL2018-12-14
48864SUPPL2017-06-29
17163SUPPL2013-06-05
38459SUPPL2011-04-01
7128SUPPL2011-04-01
38458SUPPL2010-09-07
29487SUPPL2010-08-30
44719ORIG2008-11-06
21972ORIG2008-11-06
7127ORIG2008-07-01