FDA.reportPublic FDA data

Application 022052

Type
NDA
Sponsor
CHIESI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYFLO CRZILEUTONTABLET, EXTENDED RELEASE;ORAL600MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10122-902ZYFLO CRzileutonChiesi USA, Inc.NDACurrent
10122-902ZYFLO CRzileutonChiesi USA, Inc.NDACurrent
10122-902ZYFLO CRzileutonChiesi USA, Inc.NDACurrent
66993-485ZileutonZileutonPrasco, LLCNDA AUTHORIZED Current
66993-485ZileutonZileutonPrasco, LLCNDA AUTHORIZED GENERICCurrent
66993-485ZileutonZileutonPrasco, LLCNDA AUTHORIZED GENERICCurrent
66993-485ZileutonZileutonPrasco, LLCNDA AUTHORIZED GENERICCurrent
66993-485ZileutonZileutonPrasco, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57122SUPPL2019-01-04
57094SUPPL2019-01-02
38147SUPPL2011-12-02
6775SUPPL2011-12-01
6774SUPPL2009-11-12
16848SUPPL2009-08-28
42402ORIG2008-10-03
29157ORIG2007-06-04
16847ORIG2007-06-04