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Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate Drug - Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate 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; Hydrocortisone Acetate; Neomycin Sulfate; Polymyxin B Sulfate Multiple ingredients are in alphabetical order. Strength - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM The potency of the active ingredient(s), Bacitracin; Hydrocortisone Acetate; Neomycin Sulfate; Polymyxin B Sulfate. May repeat for multiple part products. Applicant - PHARMADERM The firm name holding legal responsibility for Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 062166 The FDA assigned number to Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate. Format is nnnnnn. Product Number - 002 The FDA assigned number to identify Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate. 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 W/ Hydrocortisone Acetate 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 Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate. 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 Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate 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 W/ Hydrocortisone Acetate. Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Bacitracin Zinc-neomycin Sulfate-polymyxin B Sulfate 400 Units/gm;eq 3.5mg Base/gm;5,000 Units/gm Ointment; Topical Polysporin 10,000 Units/gm;2,000,000 Units/gm Aerosol; Topical Bacitracin Zinc And Polymyxin B Sulfate 500 Units/gm;10,000 Units/gm Ointment; Ophthalmic Bacitracin Zinc And Polymyxin B Sulfate 500 Units/gm;10,000 Units/gm Ointment; Ophthalmic Bacitracin Zinc And Polymyxin B Sulfate 500 Units/gm;10,000 Units/gm Ointment; Ophthalmic Ocumycin 500 Units/gm;10,000 Units/gm Ointment; Ophthalmic Polysporin 500 Units/gm;10,000 Units/gm Ointment; Ophthalmic Bacitracin Zinc-polymyxin B Sulfate 500 Units/gm;10,000 Units/gm Ointment; Topical Bacitracin-neomycin-polymyxin W/ Hydrocortisone Acetate 400 Units/gm;1%;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic NewDrugInformation