FDA.report

Application 020309

Type
NDA
Sponsor
HOSPIRA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION4GM/100ML (40MG/ML)YesYes
002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION4GM/50ML (80MG/ML)YesYes
003MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION2GM/50ML (40MG/ML)YesNo
004MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION20GM/500ML (40MG/ML)YesNo
005MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION40GM/1000ML (40MG/ML)YesNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2050Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-2050Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-4121Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-5239Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6729Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
0409-6730Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERHospira, Inc.NDACurrent
50090-2376Magnesium Sulfate in WaterMAGNESIUM SULFATE IN WATERA-S Medication SolutionsNDACurrent
51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent
51662-1352MAGNESIUM SULFATEMAGNESIUM SULFATEHF Acquisition Co LLC, DBA HealthFirstNDACurrent

Documents

DocumentSubmission typeDate
72130SUPPL2022-09-21
72100SUPPL2022-09-19
34495SUPPL2013-06-04
24760SUPPL2013-05-30
41277ORIG2011-02-15
24759SUPPL2007-02-12