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Isolyte M W/ Dextrose 5% In Plastic Container Drug - Isolyte M W/ Dextrose 5% In Plastic Container 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) - Dextrose; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride Multiple ingredients are in alphabetical order. Strength - 5GM/100ML;150MG/100ML;130MG/100ML;280MG/100ML;91MG/100ML The potency of the active ingredient(s), Dextrose; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Acetate; Sodium Chloride. May repeat for multiple part products. Applicant - B BRAUN The firm name holding legal responsibility for Isolyte M W/ Dextrose 5% In Plastic Container. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 018270 The FDA assigned number to Isolyte M W/ Dextrose 5% In Plastic Container. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Isolyte M W/ Dextrose 5% 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 - Approved Prior to Jan 1, 1982 The date Isolyte M W/ Dextrose 5% 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 Isolyte M W/ Dextrose 5% In Plastic Container. The RLD identifies the product Abbreviated New Drug Applications (ANDA) use as a reference. Format is Yes or No. Type - DISCN The group or category of approved drugs Isolyte M W/ Dextrose 5% 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 Isolyte M W/ Dextrose 5% In Plastic Container. Isolyte M W/ Dextrose 5% In Plastic Container Ionosol T And Dextrose 5% In Plastic Container 5gm/100ml;111mg/100ml;256mg/100ml;146mg/100ml;207mg/100ml Injectable; Injection Isolyte M In Dextrose 5% In Plastic Container 5gm/100ml;150mg/100ml;130mg/100ml;280mg/100ml;91mg/100ml Injectable; Injection Isolyte M W/ Dextrose 5% In Plastic Container 5gm/100ml;150mg/100ml;130mg/100ml;280mg/100ml;91mg/100ml Injectable; Injection Potassium Chloride 0.22% In Dextrose 5% In Plastic Container 5gm/100ml;220mg/100ml Injectable; Injection Potassium Chloride 0.22% In Dextrose 5% In Plastic Container 5gm/100ml;220mg/100ml Injectable; Injection Potassium Chloride 0.3% In Dextrose 5% In Plastic Container 5gm/100ml;300mg/100ml Injectable; Injection Potassium Chloride 0.3% In Dextrose 5% In Plastic Container 5gm/100ml;300mg/100ml Injectable; Injection Potassium Chloride 20meq In Dextrose 5% In Plastic Container 5gm/100ml;149mg/100ml Injectable; Injection Potassium Chloride 30meq In Dextrose 5% In Plastic Container 5gm/100ml;224mg/100ml Injectable; Injection Potassium Chloride 40meq In Dextrose 5% In Plastic Container 5gm/100ml;298mg/100ml Injectable; Injection NewDrugInformation