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Poly-pred Drug - Poly-pred The trade name of the product as shown on the labeling. Dosage - SUSPENSION/DROPS; OPHTHALMIC The product dosage form and route separated by a semi-colon. Active Ingredient(s) - Neomycin Sulfate; Polymyxin B Sulfate; Prednisolone Acetate Multiple ingredients are in alphabetical order. Strength - EQ 0.35% BASE;10,000 UNITS/ML;0.5% The potency of the active ingredient(s), Neomycin Sulfate; Polymyxin B Sulfate; Prednisolone Acetate. May repeat for multiple part products. Applicant - ALLERGAN The firm name holding legal responsibility for Poly-pred. The firm name is condensed to a maximum twenty character unique string. New Drug Application (NDA) Number - 050081 The FDA assigned number to Poly-pred. Format is nnnnnn. Product Number - 002 The FDA assigned number to identify Poly-pred. 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 Poly-pred 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 Poly-pred. 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 Poly-pred is in. Format is RX, OTC, DISCN. Applicant Full Name - Allergan Pharmaceutical The full name of the firm holding legal responsibility for the new application of Poly-pred. Poly-pred Neosporin G.U. Irrigant Eq 40mg Base/ml;200,000 Units/ml Solution; Irrigation Poly-pred Eq 0.35% Base;10,000 Units/ml;0.5% Suspension/drops; Ophthalmic Neomycin Sulfate Eq 350mg Base Tablet; Oral Neomycin Sulfate Eq 350mg Base Tablet; Oral Neomycin Sulfate Eq 350mg Base Tablet; Oral Neosporin Eq 3.5mg Base/gm;10,000 Units/gm Cream; Topical Statrol Eq 3.5mg Base/gm;10,000 Units/gm Ointment; Ophthalmic Statrol Eq 3.5mg Base/ml;16,250 Units/ml Solution/drops; Ophthalmic Statrol Eq 3.5mg Base/ml;16,250 Units/ml Solution/drops; Ophthalmic Neomycin And Polymyxin B Sulfates Eq 40mg Base/ml;200,000 Units/ml Solution; Irrigation NewDrugInformation