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Tis-u-sol Drug - Tis-u-sol The trade name of the product as shown on the labeling. Dosage - SOLUTION; IRRIGATION The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Magnesium Sulfate; Potassium Chloride; Potassium Phosphate, Monobasic; Sodium Chloride; Sodium Phosphate Multiple ingredients are in alphabetical order. Strength - 20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML The potency of the active ingredient(s), Magnesium Sulfate; Potassium Chloride; Potassium Phosphate, Monobasic; Sodium Chloride; Sodium Phosphate. May repeat for multiple part products. Applicant - BAXTER HLTHCARE The firm name holding legal responsibility for Tis-u-sol. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 018508 The FDA assigned number to Tis-u-sol. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Tis-u-sol. 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 - Feb 19, 1982 The date Tis-u-sol 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 Tis-u-sol. 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 Tis-u-sol is in. Format is RX, OTC, DISCN. Applicant Full Name - Baxter Healthcare Corp The full name of the firm holding legal responsibility for the new application of Tis-u-sol. Tis-u-sol Tis-u-sol 20mg/100ml;40mg/100ml;6.25mg/100ml;800mg/100ml;8.75mg/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 Magnesium Sulfate 500mg/ml Injectable; Injection Magnesium Sulfate In Dextrose 5% In Plastic Container 1gm/100ml Injectable; Injection Magnesium Sulfate In Dextrose 5% In Plastic Container 2gm/100ml Injectable; Injection Magnesium Sulfate In Plastic Container 4gm/100ml Injectable; Injection Magnesium Sulfate In Plastic Container 80mg/ml Injectable; Injection NewDrugInformation