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Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone Drug - Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone The trade name of the product as shown on the labeling. Dosage - SUSPENSION/DROPS; OPHTHALMIC 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 - PHARMAFAIR The firm name holding legal responsibility for Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 062623 The FDA assigned number to Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone. 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 - Sep 24, 1985 The date Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone 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 Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone. 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 Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone is in. Format is RX, OTC, DISCN. Applicant Full Name - Pharmafair Inc The full name of the firm holding legal responsibility for the new application of Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone. Neomycin Sulfate-polymyxin B Sulfate-hydrocortisone 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 Neo-cort-dome 1%;eq 3.5mg Base/gm Cream; Topical NewDrugInformation