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Wydase Drug - Wydase 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) - Hyaluronidase Multiple ingredients are in alphabetical order. Strength - 150 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** The potency of the active ingredient(s), Hyaluronidase. May repeat for multiple part products. Applicant - BAXTER HLTHCARE The firm name holding legal responsibility for Wydase. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 006343 The FDA assigned number to Wydase. Format is nnnnnn. Product Number - 006 The FDA assigned number to identify Wydase. 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 Wydase 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 Wydase. 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 Wydase is in. Format is RX, OTC, DISCN. Applicant Full Name - Baxter Healthcare Corp Anesthesia And Critical Care The full name of the firm holding legal responsibility for the new application of Wydase. Wydase Amphadase 150 Units/ml Injectable; Injection Hydase 150 Units/ml Injectable; Injection Vitrase 200 Units/vial Injectable; Injection Vitrase 6,200 Units/vial Injectable; Injection Wydase 1,500 Units/vial **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Injectable; Injection Wydase 150 Units/ml **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Injectable; Injection Wydase 150 Units/vial **federal Register Determination That Product Was Not Discontinued Or Withdrawn For Safety Or Efficacy Reasons** Injectable; Injection Homatroprine Methylbromide And Hydrocodone Bitartrate 1.5mg;5mg Tablet; Oral Hycodan 1.5mg;5mg Tablet; Oral Tussigon 1.5mg;5mg Tablet; Oral NewDrugInformation