FDA.reportPublic FDA data

Application 021348

Type
NDA
Sponsor
ACTELION PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZAVESCAMIGLUSTATCAPSULE;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10148-201MiglustatmiglustatCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-201MiglustatmiglustatCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-201MiglustatmiglustatCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-201MiglustatmiglustatCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-201MiglustatmiglustatCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-201MiglustatmiglustatCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
10148-201MiglustatmiglustatCoTherix, Inc.NDA AUTHORIZED GENERICCurrent
66215-201ZavescamiglustatActelion Pharmaceuticals US, Inc.NDACurrent
66215-201ZavescamiglustatActelion Pharmaceuticals US, Inc.NDACurrent
66215-201ZavescamiglustatActelion Pharmaceuticals US, Inc.NDACurrent
66215-201ZavescamiglustatActelion Pharmaceuticals US, Inc.NDACurrent
66215-201ZavescamiglustatActelion Pharmaceuticals US, Inc.NDACurrent
66215-201ZavescamiglustatActelion Pharmaceuticals US, Inc.NDACurrent
66215-201ZavescamiglustatActelion Pharmaceuticals US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65562SUPPL2020-12-10
65540SUPPL2020-12-09
59186SUPPL2019-06-27
36726SUPPL2014-02-11
5123SUPPL2014-02-11
5122SUPPL2010-11-29
36725SUPPL2010-11-23
36724SUPPL2008-03-05
27560SUPPL2008-03-04
21612ORIG2003-12-15
36723ORIG2003-08-15
27559ORIG2003-08-15