Web NewDrugInformation.com

Dialyte Concentrate W/ Dextrose 50% In Plastic Container Drug - Dialyte Concentrate W/ Dextrose 50% 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 Acetate; Sodium Chloride Multiple ingredients are in alphabetical order. Strength - 510MG/100ML;50GM/100ML;200MG/100ML;9.2GM/100ML;9.6GM/100ML The potency of the active ingredient(s), Calcium Chloride; Dextrose; Magnesium Chloride; Sodium Acetate; Sodium Chloride. May repeat for multiple part products. Applicant - B BRAUN The firm name holding legal responsibility for Dialyte Concentrate W/ Dextrose 50% In Plastic Container. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 018807 The FDA assigned number to Dialyte Concentrate W/ Dextrose 50% In Plastic Container. Format is nnnnnn. Product Number - 002 The FDA assigned number to identify Dialyte Concentrate W/ Dextrose 50% In Plastic Container. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Aug 26, 1983 The date Dialyte Concentrate W/ Dextrose 50% 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 Dialyte Concentrate W/ Dextrose 50% 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 Dialyte Concentrate W/ Dextrose 50% In Plastic Container is in. Format is RX, OTC, DISCN. Applicant Full Name - B Braun Medical Inc The full name of the firm holding legal responsibility for the new application of Dialyte Concentrate W/ Dextrose 50% In Plastic Container. Dialyte Concentrate W/ Dextrose 50% In Plastic Container Isolyte E In Dextrose 5% In Plastic Container 35mg/100ml;5gm/100ml;30mg/100ml;74mg/100ml;640mg/100ml;500mg/100ml;74mg/100ml Injectable; Injection Isolyte E W/ Dextrose 5% In Plastic Container 35mg/100ml;5gm/100ml;30mg/100ml;74mg/100ml;640mg/100ml;500mg/100ml;74mg/100ml Injectable; Injection Plasma-lyte M And Dextrose 5% In Plastic Container 37mg/100ml;5gm/100ml;30mg/100ml;119mg/100ml;161mg/100ml;94mg/100ml;138mg/100ml Injectable; Injection 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 Bss Plus 0.154mg/ml;0.92mg/ml;0.184mg/ml;0.2mg/ml;0.38mg/ml;2.1mg/ml;7.14mg/ml;0.42mg/ml Solution; Irrigation Endosol Extra 0.154mg/ml;0.92mg/ml;0.184mg/ml;0.2mg/ml;0.38mg/ml;2.1mg/ml;7.14mg/ml;0.42mg/ml Solution; Irrigation Isolyte R In Dextrose 5% In Plastic Container 37mg/100ml;5gm/100ml;31mg/100ml;120mg/100ml;330mg/100ml;88mg/100ml Injectable; Injection Isolyte R W/ Dextrose 5% In Plastic Container 37mg/100ml;5gm/100ml;31mg/100ml;120mg/100ml;330mg/100ml;88mg/100ml Injectable; Injection NewDrugInformation