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Polysporin Drug - Polysporin 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 - MONARCH PHARMS The firm name holding legal responsibility for Polysporin. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 061229 The FDA assigned number to Polysporin. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Polysporin. 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 Polysporin 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 Polysporin. 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 Polysporin 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 Polysporin. Polysporin 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 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 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