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Otobione Drug - Otobione The trade name of the product as shown on the labeling. Dosage - SUSPENSION/DROPS; OTIC The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate Multiple ingredients are in alphabetical order. Strength - 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML The potency of the active ingredient(s), Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate. May repeat for multiple part products. Applicant - SCHERING The firm name holding legal responsibility for Otobione. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 061816 The FDA assigned number to Otobione. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Otobione. 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 Otobione 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 Otobione. 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 Otobione is in. Format is RX, OTC, DISCN. Applicant Full Name - Schering Corp Sub Schering Plough Corp The full name of the firm holding legal responsibility for the new application of Otobione. Otobione Neomycin And Polymyxin B Sulfates And Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic Neomycin Sulfate, Polymyxin B Sulfate & Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic Oticair 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic Oticair 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic Otobione 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic Otocort 1%;eq 3.5mg Base/ml;10,000 Units/ml Solution/drops; Otic Cortisporin 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Neomycin And Polymyxin B Sulfates And Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Ophthalmic Cortisporin 1%;eq 3.5mg Base/ml;10,000 Units/ml Suspension/drops; Otic NewDrugInformation