FDA.reportPublic FDA data

Application 075151

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAGNESIUM SULFATEMAGNESIUM SULFATESOLUTION;INTRAMUSCULAR, INTRAVENOUS5GM/10ML (500MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-9903Magnesium SulfateMagnesium Sulfate HeptahydrateHenry Schein, Inc.ANDACurrent
0404-9903Magnesium SulfateMagnesium Sulfate HeptahydrateHenry Schein, Inc.ANDACurrent
0409-1754Magnesium Sulfatemagnesium sulfateHospira, Inc.ANDACurrent
0409-1754Magnesium Sulfatemagnesium sulfateHospira, Inc.ANDACurrent
0409-1754Magnesium Sulfatemagnesium sulfateHospira, Inc.ANDACurrent
0409-1754Magnesium Sulfatemagnesium sulfateHospira, Inc.ANDACurrent
0409-1754Magnesium Sulfatemagnesium sulfateHospira, Inc.ANDACurrent
51662-123550% MAGNESIUM SULFATE50% MAGNESIUM SULFATEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
51662-123550% MAGNESIUM SULFATE50% MAGNESIUM SULFATEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
51662-123550% MAGNESIUM SULFATE50% MAGNESIUM SULFATEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
51662-123550% MAGNESIUM SULFATE50% MAGNESIUM SULFATEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
51662-123550% MAGNESIUM SULFATE50% MAGNESIUM SULFATEHF Acquisition Co. LLC, DBA Health FirstANDACurrent
52584-754Magnesium SulfateMagnesium Sulfate HeptahydrateGeneral Injectables & Vaccines, IncANDACurrent
52584-754Magnesium SulfateMagnesium Sulfate HeptahydrateGeneral Injectables & Vaccines, IncANDACurrent
52584-754Magnesium SulfateMagnesium Sulfate HeptahydrateGeneral Injectables & Vaccines, IncANDACurrent
52584-754Magnesium SulfateMagnesium Sulfate HeptahydrateGeneral Injectables & Vaccines, IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30775ORIG2000-04-25