FDA.reportPublic FDA data

Application 213917

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION2GM/50ML (40MG/ML)NoNo
002MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION4GM/100ML (40MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-612Magnesium SulfateMagnesium Sulfate HeptahydrateSagent PharmaceuticalsANDACurrent
47335-992MAGNESIUM SULFATEmagnesium sulfate heptahydrateSun Pharmaceutical Industries, Inc.ANDACurrent
68083-396MAGNESIUM SULFATEMAGNESIUM SULFATE HEPTAHYDRATEGland Pharma LimitedANDACurrent
68083-397MAGNESIUM SULFATEMAGNESIUM SULFATE HEPTAHYDRATEGland Pharma LimitedANDACurrent