FDA.reportPublic FDA data

Application 206486

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-108Magnesium Sulfate in 5% DextroseMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCANDACurrent
63323-108Magnesium Sulfate in 5% DextroseMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCANDACurrent
63323-108Magnesium Sulfate in 5% DextroseMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCANDACurrent
63323-108Magnesium Sulfate in 5% DextroseMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCANDACurrent
63323-108Magnesium Sulfate in 5% DextroseMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCANDACurrent
63323-108Magnesium Sulfate in 5% DextroseMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCANDACurrent
63323-108Magnesium Sulfate in 5% DextroseMagnesium Sulfate HeptahydrateFresenius Kabi USA, LLCANDACurrent