FDA.reportPublic FDA data

Application 208746

Type
NDA
Sponsor
HOSPIRA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PEMETREXEDPEMETREXEDPOWDER;INTRAVENOUSEQ 100MG BASE/VIALNoNo
002PEMETREXEDPEMETREXEDPOWDER;INTRAVENOUSEQ 500MG BASE/VIALNoNo
003PEMETREXEDPEMETREXEDPOWDER;INTRAVENOUSEQ 1G BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-1060PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1060PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1060PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1060PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1061PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1061PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1061PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1061PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1062PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1062PemetrexedPemetrexedHospira, Inc.NDACurrent
0409-1062PemetrexedPemetrexedHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73084ORIG2023-01-04
71286ORIG2022-06-13
71271ORIG2022-06-13
65892ORIG2021-01-12