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Magnesium Sulfate Drug - Magnesium Sulfate The trade name of the product as shown on the labeling. Dosage - INJECTABLE; INJECTION The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Magnesium Sulfate Multiple ingredients are in alphabetical order. Strength - 500MG/ML The potency of the active ingredient(s), Magnesium Sulfate. May repeat for multiple part products. Applicant - AM PHARM PARTNERS The firm name holding legal responsibility for Magnesium Sulfate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 019316 The FDA assigned number to Magnesium Sulfate. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Magnesium Sulfate. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AP The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Sep 8, 1986 The date Magnesium Sulfate was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982". Reference Listed Drug (RLD) - Yes The pioneer or innovator of Magnesium Sulfate. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - RX The group or category of approved drugs Magnesium Sulfate is in. Format is RX, OTC, DISCN. Applicant Full Name - American Pharmaceutical Partners Inc The full name of the firm holding legal responsibility for the new application of Magnesium Sulfate. Magnesium Sulfate Physiosol In Plastic Container 14mg/100ml;37mg/100ml;222mg/100ml;526mg/100ml;502mg/100ml Solution; Irrigation Physiosol In Plastic Container 30mg/100ml;37mg/100ml;222mg/100ml;526mg/100ml;502mg/100ml Solution; Irrigation Physiosol Ph 7.4 In Plastic Container 30mg/100ml;37mg/100ml;222mg/100ml;526mg/100ml;502mg/100ml Solution; Irrigation Synovalyte In Plastic Container 30mg/100ml;37mg/100ml;368mg/100ml;526mg/100ml;502mg/100ml Solution; Irrigation Magnesium Sulfate 500mg/ml Injectable; Injection Isolyte S In Plastic Container 30mg/100ml;37mg/100ml;370mg/100ml;530mg/100ml;500mg/100ml Injectable; Injection Normosol-r In Plastic Container 30mg/100ml;37mg/100ml;222mg/100ml;526mg/100ml;502mg/100ml Injectable; Injection Plasma-lyte 148 In Water In Plastic Container 30mg/100ml;37mg/100ml;368mg/100ml;526mg/100ml;502mg/100ml Injectable; Injection Plasma-lyte A In Plastic Container 30mg/100ml;37mg/100ml;368mg/100ml;526mg/100ml;502mg/100ml Injectable; Injection Physiolyte In Plastic Container 30mg/100ml;37mg/100ml;370mg/100ml;530mg/100ml;500mg/100ml Solution; Irrigation NewDrugInformation