FDA.reportPublic FDA data

Application 209191

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BORTEZOMIBBORTEZOMIBPOWDER;INTRAVENOUS, SUBCUTANEOUS2.5MG/VIALYesNo
002BORTEZOMIBBORTEZOMIBPOWDER;INTRAVENOUS, SUBCUTANEOUS1MG/VIALYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1703BORTEZOMIBBORTEZOMIBHospira, Inc.NDACurrent
0409-1703BORTEZOMIBBORTEZOMIBHospira, Inc.NDACurrent
0409-1704BORTEZOMIBBORTEZOMIBHospira, Inc.NDACurrent
0409-1704BORTEZOMIBBORTEZOMIBHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72863SUPPL2022-12-12
72855SUPPL2022-12-12
72803ORIG2022-12-07
70981ORIG2022-05-04
69717ORIG2021-12-21
56420ORIG2018-11-13
54878ORIG2018-07-13
56089ORIG2018-07-12
48131ORIG2017-04-27