FDA.reportPublic FDA data

Application 020488

Type
NDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION1GM/100MLYesYes
002MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION2GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-6727Magnesium Sulfate in DextroseMagnesium Sulfate in DextroseHospira, Inc.NDACurrent
0409-6727Magnesium Sulfate in DextroseMagnesium Sulfate in DextroseHospira, Inc.NDACurrent
0409-6727Magnesium Sulfate in DextroseMagnesium Sulfate in DextroseHospira, Inc.NDACurrent
0409-6727Magnesium Sulfate in DextroseMagnesium Sulfate in DextroseHospira, Inc.NDACurrent
0409-6727Magnesium Sulfate in DextroseMagnesium Sulfate in DextroseHospira, Inc.NDACurrent
0409-6727Magnesium Sulfate in DextroseMagnesium Sulfate in DextroseHospira, Inc.NDACurrent
0409-6727Magnesium Sulfate in DextroseMagnesium Sulfate in DextroseHospira, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58350SUPPL2019-04-18
58343SUPPL2019-04-18
25036SUPPL2013-06-05
34703SUPPL2013-06-04
41393ORIG1995-07-01