FDA.reportPublic FDA data

Application 207350

Type
ANDA
Sponsor
HQ SPCLT PHARMA

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
003MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION4GM/50ML (80MG/ML)NoNo
004MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION20GM/500ML (40MG/ML)NoNo
005MAGNESIUM SULFATE IN PLASTIC CONTAINERMAGNESIUM SULFATEINJECTABLE;INJECTION40GM/1000ML (40MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44567-420Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-420Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-420Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-421Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-421Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-421Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-422Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-422Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-422Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-423Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-423Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-423Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-424Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-424Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent
44567-424Magnesium SulfateMagnesium SulfateWG Critical Care, LLCANDACurrent