FDA.reportPublic FDA data

Application 209911

Type
ANDA
Sponsor
MYLAN LABS 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
67457-553Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMylan Institutional LLCANDACurrent
67457-553Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMylan Institutional LLCANDACurrent
67457-553Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMylan Institutional LLCANDACurrent
67457-554Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMylan Institutional LLCANDACurrent
67457-554Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMylan Institutional LLCANDACurrent
67457-554Magnesium SulfateMAGNESIUM SULFATE HEPTAHYDRATEMylan Institutional LLCANDACurrent