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Isopaque 280 Drug - Isopaque 280 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) - Calcium; Meglumine; Metrizoic Acid Multiple ingredients are in alphabetical order. Strength - 0.35MG/ML;140.1MG/ML;461.8MG/ML The potency of the active ingredient(s), Calcium; Meglumine; Metrizoic Acid. May repeat for multiple part products. Applicant - GE HEALTHCARE The firm name holding legal responsibility for Isopaque 280. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 017506 The FDA assigned number to Isopaque 280. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Isopaque 280. 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 Isopaque 280 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 Isopaque 280. 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 Isopaque 280 is in. Format is RX, OTC, DISCN. Applicant Full Name - Ge Healthcare The full name of the firm holding legal responsibility for the new application of Isopaque 280. Isopaque 280 Isopaque 280 0.35mg/ml;140.1mg/ml;461.8mg/ml Injectable; Injection Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation Lactated Ringer's In Plastic Container 20mg/100ml;30mg/100ml;600mg/100ml;310mg/100ml Solution; Irrigation Calcium Gluceptate Eq 90mg Calcium/5ml Injectable; Injection Calcium Gluceptate Eq 90mg Calcium/5ml Injectable; Injection Calcium Gluceptate Eq 90mg Calcium/5ml Injectable; Injection Calcium Gluceptate Eq 90mg Calcium/5ml Injectable; Injection Isopaque 440 0.78mg/ml;75.9mg/ml;0.15mg/ml;16.6mg/ml Injectable; Injection NewDrugInformation