FDA.reportPublic FDA data

Application 016269

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MANNITOL 5%MANNITOLINJECTABLE;INJECTION5GM/100MLNoNo
002MANNITOL 10%MANNITOLINJECTABLE;INJECTION10GM/100MLNoNo
003MANNITOL 15%MANNITOLINJECTABLE;INJECTION15GM/100MLNoNo
004MANNITOL 20%MANNITOLINJECTABLE;INJECTION20GM/100MLNoNo
005MANNITOL 25%MANNITOLINJECTABLE;INJECTION12.5GM/50MLNoNo
006MANNITOL 25%MANNITOLINJECTABLE;INJECTION12.5GM/50MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9905MannitolMannitolHenry Schein, Inc.NDACurrent
0404-9905MannitolMannitolHenry Schein, Inc.NDACurrent
0409-4031MannitolMANNITOLHospira, Inc.NDACurrent
0409-4031MannitolMANNITOLHospira, Inc.NDACurrent
0409-4031MannitolMANNITOLHospira, Inc.NDACurrent
0409-4031MannitolMANNITOLHospira, Inc.NDACurrent
0409-4031MannitolMANNITOLHospira, Inc.NDACurrent
51662-1468MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1468MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1468MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirstNDACurrent
52584-031MannitolMannitolGeneral Injectables & Vaccines, IncANDACurrent
52584-031MannitolMannitolGeneral Injectables & Vaccines, IncNDACurrent
52584-031MannitolMannitolGeneral Injectables & Vaccines, IncNDACurrent
52584-031MannitolMannitolGeneral Injectables & Vaccines, IncNDACurrent
52584-031MannitolMannitolGeneral Injectables & Vaccines, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62195SUPPL2020-03-19
62187SUPPL2020-03-18
57334SUPPL2019-01-23
57171SUPPL2019-01-10