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Md-50 Drug - Md-50 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) - Diatrizoate Sodium Multiple ingredients are in alphabetical order. Strength - 50% The potency of the active ingredient(s), Diatrizoate Sodium. May repeat for multiple part products. Applicant - MALLINCKRODT The firm name holding legal responsibility for Md-50. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 087075 The FDA assigned number to Md-50. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Md-50. 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 Md-50 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 Md-50. 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 Md-50 is in. Format is RX, OTC, DISCN. Applicant Full Name - Mallinckrodt Inc The full name of the firm holding legal responsibility for the new application of Md-50. Md-50 Gastrografin 66%;10% Solution; Oral, Rectal Gastrovist 66%;10% Solution; Oral, Rectal Md-gastroview 66%;10% Solution; Oral, Rectal Sinografin 52.7%;26.8% Solution; Intrauterine Hypaque 100% For Solution; Oral, Rectal Hypaque 25% Injectable; Injection Hypaque 50% Injectable; Injection Md-50 50% Injectable; Injection Renovist 34.3%;35% Injectable; Injection Renovist Ii 28.5%;29.1% Injectable; Injection NewDrugInformation