FDA.reportPublic FDA data

Application 212576

Type
NDA
Sponsor
ASTEX PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INQOVIDECITABINE;CEDAZURIDINETABLET;ORAL35MG;100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64842-0727INQOVICEDAZURIDINE and DECITABINETaiho Pharmaceutical Co., Ltd.NDACurrent
64842-0727INQOVICEDAZURIDINE and DECITABINETaiho Pharmaceutical Co., Ltd.NDACurrent
64842-0727INQOVICEDAZURIDINE and DECITABINETaiho Pharmaceutical Co., Ltd.NDACurrent
64842-0727INQOVICEDAZURIDINE and DECITABINETaiho Pharmaceutical Co., Ltd.NDACurrent
64842-0727INQOVICEDAZURIDINE and DECITABINETaiho Pharmaceutical Co., Ltd.NDACurrent
64842-0727INQOVICEDAZURIDINE and DECITABINETaiho Pharmaceutical Co., Ltd.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85926SUPPL 2026-05-18
85918SUPPL 2026-05-15
70609SUPPL2022-03-25
70603SUPPL2022-03-25
64100ORIG2020-07-27
63821ORIG2020-07-08
63820ORIG2020-07-07