FDA.reportPublic FDA data

Application 022075

Type
NDA
Sponsor
KYOWA KIRIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NOURIANZISTRADEFYLLINETABLET;ORAL20MGYesNo
002NOURIANZISTRADEFYLLINETABLET;ORAL40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42747-602NOURIANZistradefyllineKyowa Kirin, Inc.NDACurrent
42747-602NOURIANZistradefyllineKyowa Kirin, Inc.NDACurrent
42747-602NOURIANZistradefyllineKyowa Kirin, Inc.NDACurrent
42747-604NOURIANZistradefyllineKyowa Kirin, Inc.NDACurrent
42747-604NOURIANZistradefyllineKyowa Kirin, Inc.NDACurrent
42747-604NOURIANZistradefyllineKyowa Kirin, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60257ORIG2019-10-07
59869ORIG2019-08-29
59861ORIG2019-08-27