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Bacitracin-neomycin-polymyxin Drug - Bacitracin-neomycin-polymyxin The trade name of the product as shown on the labeling. Dosage - OINTMENT; OPHTHALMIC The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate Multiple ingredients are in alphabetical order. Strength - 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 UNITS/GM The potency of the active ingredient(s), Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate. May repeat for multiple part products. Applicant - PHARMADERM The firm name holding legal responsibility for Bacitracin-neomycin-polymyxin. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 062167 The FDA assigned number to Bacitracin-neomycin-polymyxin. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Bacitracin-neomycin-polymyxin. 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 Bacitracin-neomycin-polymyxin 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 Bacitracin-neomycin-polymyxin. 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 Bacitracin-neomycin-polymyxin is in. Format is RX, OTC, DISCN. Applicant Full Name - Pharmaderm Div Altana Inc The full name of the firm holding legal responsibility for the new application of Bacitracin-neomycin-polymyxin. Bacitracin-neomycin-polymyxin Zinc Bacitracin,neomycin Sulfate,polymyxin B Sulfate & Hydrocortisone 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Cortisporin 400 Units/gm;1%;eq 3.5mg Base/gm;5,000 Units/gm Ointment; Topical Neomycin & Polymyxin B Sulfates & Bacitracin Zinc & Hydrocortisone 400 Units/gm;1%;eq 3.5mg Base/gm;5,000 Units/gm Ointment; Topical Lanabiotic 400 Units/gm;40mg/gm;eq 5mg Base/gm;5,000 Units/gm Ointment; Topical Bacitracin Zinc-neomycin Sulfate-polymyxin B Sulfate 400 Units/gm;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Bacitracin-neomycin-polymyxin 400 Units/gm;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Bacitracin-neomycin-polymyxin 400 Units/gm;eq 3.5mg Base/gm;5,000 Units/gm Ointment; Ophthalmic Ziba-rx 500,000 Units/bot Powder; For Rx Compounding Cortisporin 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic NewDrugInformation