Web NewDrugInformation.com

Bss Drug - Bss 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) - Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Citrate Multiple ingredients are in alphabetical order. Strength - 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML The potency of the active ingredient(s), Calcium Chloride; Magnesium Chloride; Potassium Chloride; Sodium Acetate; Sodium Chloride; Sodium Citrate. May repeat for multiple part products. Applicant - ALCON The firm name holding legal responsibility for Bss. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 020742 The FDA assigned number to Bss. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Bss. 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 - Dec 10, 1997 The date Bss 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 Bss. 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 Bss is in. Format is RX, OTC, DISCN. Applicant Full Name - Alcon Laboratories Inc The full name of the firm holding legal responsibility for the new application of Bss. Bss Isolyte E In Plastic Container 35mg/100ml;30mg/100ml;74mg/100ml;640mg/100ml;500mg/100ml;74mg/100ml Injectable; Injection Bss 0.48mg/ml;0.3mg/ml;0.75mg/ml;3.9mg/ml;6.4mg/ml;1.7mg/ml Solution; Irrigation Potassium Chloride 5meq In Dextrose 5% And Lactated Ringer's In Plastic Container 20mg/100ml;5gm/100ml;105mg/100ml;600mg/100ml;310mg/100ml Injectable; Injection Potassium Chloride 5meq In Dextrose 5% And Lactated Ringer's In Plastic Container 20mg/100ml;5gm/100ml;104mg/100ml;600mg/100ml;310mg/100ml Injectable; Injection Inpersol-zm W/ Dextrose 1.5% In Plastic Container 25.7mg/100ml;1.5gm/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal Inpersol-zm W/ Dextrose 2.5% In Plastic Container 25.7mg/100ml;2.5gm/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal Inpersol-zm W/ Dextrose 4.25% In Plastic Container 25.7mg/100ml;4.25gm/100ml;538mg/100ml;448mg/100ml Solution; Intraperitoneal Tpn Electrolytes In Plastic Container 16.5mg/ml;25.4mg/ml;74.6mg/ml;121mg/ml;16.1mg/ml Injectable; Injection Tpn Electrolytes In Plastic Container 16.5mg/ml;25.4mg/ml;74.6mg/ml;121mg/ml;16.1mg/ml Injectable; Injection Isolyte E In Plastic Container 35mg/100ml;30mg/100ml;74mg/100ml;640mg/100ml;500mg/100ml;74mg/100ml Injectable; Injection NewDrugInformation