FDA.reportPublic FDA data

Application 022198

Type
NDA
Sponsor
KYOWA KIRIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SANCUSOGRANISETRONFILM, EXTENDED RELEASE;TRANSDERMAL3.1MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42747-726SANCUSOgranisetronKyowa Kirin, Inc.NDACurrent
42747-726SancusogranisetronKyowa Kirin, Inc.NDACurrent
42747-726SANCUSOgranisetronKyowa Kirin, Inc.NDACurrent
42747-726SANCUSOgranisetronKyowa Kirin, Inc.NDACurrent
42747-726SANCUSOgranisetronKyowa Kirin, Inc.NDACurrent
42747-726SANCUSOgranisetronKyowa Kirin, Inc.NDACurrent
42747-726SANCUSOgranisetronKyowa Kirin, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79647SUPPL 2024-09-18
79637SUPPL 2024-09-17
73349SUPPL 2023-01-31
73307SUPPL2023-01-30
62807SUPPL2020-05-04
62791SUPPL2020-05-01
52502SUPPL2018-02-07
29391SUPPL2015-10-01
38367SUPPL2015-09-29
29392SUPPL2014-09-23
38369SUPPL2014-09-22
38368SUPPL2011-09-29
7028SUPPL2011-09-28
42444ORIG2009-09-30
17069ORIG2008-09-19
29390ORIG2008-09-16