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Bacitracin Zinc And Polymyxin B Sulfate Drug - Bacitracin Zinc And Polymyxin B Sulfate 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; Polymyxin B Sulfate Multiple ingredients are in alphabetical order. Strength - 500 UNITS/GM;10,000 UNITS/GM The potency of the active ingredient(s), Bacitracin Zinc; Polymyxin B Sulfate. May repeat for multiple part products. Applicant - AKORN The firm name holding legal responsibility for Bacitracin Zinc And Polymyxin B Sulfate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 064028 The FDA assigned number to Bacitracin Zinc And Polymyxin B Sulfate. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Bacitracin Zinc And Polymyxin B Sulfate. 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 - Jan 30, 1995 The date Bacitracin Zinc And Polymyxin B Sulfate 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 Zinc And Polymyxin B Sulfate. 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 Zinc And Polymyxin B Sulfate is in. Format is RX, OTC, DISCN. Applicant Full Name - Akorn Inc The full name of the firm holding legal responsibility for the new application of Bacitracin Zinc And Polymyxin B Sulfate. Bacitracin Zinc And Polymyxin B Sulfate Neosporin 400 Units/gm;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-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 Neomycin And Polymyxin B Sulfate And Bacitracin Zinc 400 Units/gm;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Neomycin And Polymyxin B Sulfates And Bacitracin Zinc 400 Units/gm;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Neo-polycin 500 Units/gm;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic NewDrugInformation