FDA.reportPublic FDA data

Application 209115

Type
NDA
Sponsor
CLOVIS ONCOLOGY INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RUBRACARUCAPARIB CAMSYLATETABLET;ORALEQ 200MG BASEYesNo
002RUBRACARUCAPARIB CAMSYLATETABLET;ORALEQ 300MG BASEYesYes
003RUBRACARUCAPARIB CAMSYLATETABLET;ORALEQ 250MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69660-201RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-201RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-201RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-201RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-201RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-201RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-202RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-202RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-202RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-202RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-202RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-202RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-203RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-203RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-203RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-203RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-203RubracarucaparibClovis Oncology, Inc.NDACurrent
69660-203RubracarucaparibClovis Oncology, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84484SUPPL 2025-12-22
84483SUPPL 2025-12-22
84469SUPPL 2025-12-19
84468SUPPL 2025-12-19
73010SUPPL2022-12-23
72997SUPPL2022-12-22
71270SUPPL2022-06-13
71269SUPPL2022-06-13
68868SUPPL2021-10-04
68856SUPPL2021-10-01
64904SUPPL2020-10-14
64885SUPPL2020-10-09
63092SUPPL2020-05-19
63052SUPPL2020-05-15
53658SUPPL2018-04-12
53633SUPPL2018-04-06
47024ORIG2017-01-30
46445ORIG2016-12-21
46206ORIG2016-12-19