Web NewDrugInformation.com

Bacitracin Zinc-polymyxin B Sulfate Drug - Bacitracin Zinc-polymyxin B Sulfate The trade name of the product as shown on the labeling. Dosage - OINTMENT; TOPICAL 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 - NASKA The firm name holding legal responsibility for Bacitracin Zinc-polymyxin B Sulfate. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 062849 The FDA assigned number to Bacitracin Zinc-polymyxin B Sulfate. Format is nnnnnn. Product Number - 001 The FDA assigned number to identify Bacitracin Zinc-polymyxin B Sulfate. 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 - Nov 13, 1987 The date Bacitracin Zinc-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-polymyxin B Sulfate. 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 Zinc-polymyxin B Sulfate is in. Format is RX, OTC, DISCN. Applicant Full Name - Naska Pharmacal Co Inc Div Rugby Darby Group Cosmetics The full name of the firm holding legal responsibility for the new application of Bacitracin Zinc-polymyxin B Sulfate. Bacitracin Zinc-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 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 Neo-polycin 500 Units/gm;eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic NewDrugInformation