FDA.reportPublic FDA data

Application 019465

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION900MG/100MLYesYes
002SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERSODIUM CHLORIDEINJECTABLE;INJECTION9MG/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-7101Sodium ChlorideSodium ChlorideHospira, Inc.NDACurrent
0409-7101Sodium ChlorideSodium ChlorideHospira, Inc.NDACurrent
0409-7101Sodium ChlorideSodium ChlorideHospira, Inc.NDACurrent
0409-7101Sodium ChlorideSodium ChlorideHospira, Inc.NDACurrent
0409-7101Sodium ChlorideSodium ChlorideHospira, Inc.NDACurrent
0409-7101Sodium ChlorideSodium ChlorideHospira, Inc.NDACurrent
0409-7101Sodium ChlorideSodium ChlorideHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45482SUPPL2016-09-30
45428SUPPL2016-09-29
17413SUPPL2016-06-14