FDA.reportPublic FDA data

Application 021779

Type
NDA
Sponsor
ACTELION PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENTAVISILOPROSTSOLUTION;INHALATION20MCG/2ML (10MCG/ML)NoNo
002VENTAVISILOPROSTSOLUTION;INHALATION10MCG/ML (10MCG/ML)YesYes
003VENTAVISILOPROSTSOLUTION;INHALATION20MCG/ML (20MCG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66215-302VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-302VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-302VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-302VentavisiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-302VentavisiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-302VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-302VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-302VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-302VentavisiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VentavisiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VentavisiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VENTAVISiloprostActelion Pharmaceuticals US, Inc.NDACurrent
66215-303VentavisiloprostActelion Pharmaceuticals US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70389SUPPL2022-03-03
70382SUPPL2022-03-03
61338SUPPL2019-12-19
61316SUPPL2019-12-17
50093SUPPL2017-10-18
50069SUPPL2017-10-17
37640SUPPL2013-11-26
28589SUPPL2013-11-25
6174SUPPL2012-05-02
37639SUPPL2012-05-01
21817SUPPL2011-10-10
6173SUPPL2011-02-14
37638SUPPL2011-02-09
37637SUPPL2010-05-03
28588SUPPL2010-04-23
28587SUPPL2010-01-27
37636SUPPL2009-09-22
37635SUPPL2008-09-25
28586SUPPL2008-09-23
6172SUPPL2008-03-07
16359SUPPL2008-03-05
37634SUPPL2005-12-15
28585SUPPL2005-12-15
37633SUPPL2005-08-31
28584SUPPL2005-08-31
28583SUPPL2005-08-31
16358SUPPL2005-08-31
42306ORIG2005-03-28
37632ORIG2005-01-11
6171ORIG2005-01-11