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Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container Drug - Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container The trade name of the product as shown on the labeling. Dosage - SOLUTION; INTRAPERITONEAL The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate Multiple ingredients are in alphabetical order. Strength - 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;538MG/100ML;448MG/100ML The potency of the active ingredient(s), Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Chloride; Sodium Lactate. May repeat for multiple part products. Applicant - FRESENIUS MEDCL The firm name holding legal responsibility for Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 018883 The FDA assigned number to Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container. Format is nnnnnn. Product Number - 004 The FDA assigned number to identify Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AT The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Nov 30, 1984 The date Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container 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) - No The pioneer or innovator of Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container. 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 Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container is in. Format is RX, OTC, DISCN. Applicant Full Name - Fresenius Medical Care North America The full name of the firm holding legal responsibility for the new application of Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container. Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container Delflex W/ Dextrose 1.5% In Plastic Container 25.7mg/100ml;1.5gm/100ml;15.2mg/100ml;567mg/100ml;392mg/100ml Solution; Intraperitoneal Delflex W/ Dextrose 1.5% In Plastic Container 25.7mg/100ml;1.5gm/100ml;15.2mg/100ml;567mg/100ml;392mg/100ml Solution; Intraperitoneal Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container 25.7mg/100ml;1.5gm/100ml;5.08mg/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal Dialyte Concentrate W/ Dextrose 30% In Plastic Container 510mg/100ml;30gm/100ml;200mg/100ml;9.2gm/100ml;9.6gm/100ml Solution; Intraperitoneal Dialyte Concentrate W/ Dextrose 30% In Plastic Container 510mg/100ml;30gm/100ml;200mg/100ml;9.4gm/100ml;11gm/100ml Solution; Intraperitoneal Dialyte Concentrate W/ Dextrose 50% In Plastic Container 510mg/100ml;50gm/100ml;200mg/100ml;9.2gm/100ml;9.6gm/100ml Solution; Intraperitoneal Dialyte Concentrate W/ Dextrose 50% In Plastic Container 510mg/100ml;50gm/100ml;200mg/100ml;9.4gm/100ml;11gm/100ml Solution; Intraperitoneal Dialyte Lm/ Dextrose 2.5% In Plastic Container 29mg/100ml;2.5gm/100ml;15mg/100ml;610mg/100ml;560mg/100ml Solution; Intraperitoneal Dialyte W/ Dextrose 1.5% In Plastic Container 29mg/100ml;1.5gm/100ml;15mg/100ml;610mg/100ml;560mg/100ml Solution; Intraperitoneal Dialyte W/ Dextrose 4.25% In Plastic Container 29mg/100ml;4.25gm/100ml;15mg/100ml;610mg/100ml;560mg/100ml Solution; Intraperitoneal NewDrugInformation