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Cortisporin Drug - Cortisporin 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 - MONARCH PHARMS The firm name holding legal responsibility for Cortisporin. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 060613 The FDA assigned number to Cortisporin. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Cortisporin. Each strength is a separate product. May repeat for multiple part products. Format is nnn. Therapeutic Equivalence (TE) Code - AT The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. Approval Date - Approved Prior to Jan 1, 1982 The date Cortisporin 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 Cortisporin. 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 Cortisporin is in. Format is RX, OTC, DISCN. Applicant Full Name - Monarch Pharmaceuticals Inc The full name of the firm holding legal responsibility for the new application of Cortisporin. Cortisporin Cortisporin 1%;eq 3.5mg Base/ml;10,000 Units/ml Solution/drops; Otic Neomycin And Polymyxin B Sulfates And Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Solution/drops; Otic Neomycin And Polymyxin B Sulfates And Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Solution/drops; Otic Neomycin And Polymyxin B Sulfates And Hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Solution/drops; Otic Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone 1%;eq 3.5mg Base/ml;10,000 Units/ml Solution/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