FDA Approval Activities for this Drug…

Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution, 1 mg (base) & 10,000 units per mL Taylor ANDA 65-006 BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE BAUSCH AND LOMB 050416 AT BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM CORTISPORIN MONARCH 050168 BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Topical 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM CORTISPORIN MONARCH 060764 AT BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM BACITRACIN-NEOMYCIN-POLYMYXIN Altana 064064 AT BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC BAUSCH AND LOMB 050417 AT BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOSPORIN MONARCH 064028 AT BACITRACIN ZINC; POLYMYXIN B SULFATE Ointment; Ophthalmic 500 UNITS/GM;10,000 UNITS/GM BACITRACIN ZINC AND POLYMYXIN B SULFATE Akorn 065022 AT BACITRACIN ZINC; POLYMYXIN B SULFATE Ointment; Ophthalmic 500 UNITS/GM;10,000 UNITS/GM BACITRACIN ZINC AND POLYMYXIN B SULFATE Altana 064046 AT BACITRACIN ZINC; POLYMYXIN B SULFATE Ointment; Ophthalmic 500 UNITS/GM;10,000 UNITS/GM BACITRACIN ZINC AND POLYMYXIN B SULFATE BAUSCH AND LOMB 061229 AT BACITRACIN ZINC; POLYMYXIN B SULFATE Ointment; Ophthalmic 500 UNITS/GM;10,000 UNITS/GM POLYSPORIN MONARCH 062166 BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE PHARMADERM 064063 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE BAUSCH AND LOMB 050065 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM MAXITROL FALCON 062938 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Ointment; Ophthalmic 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE FOUGERA 062341 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML MAXITROL Alcon 062721 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE Alcon UNIVERSAL 064135 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML DEXASPORIN BAUSCH AND LOMB 050023 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML MAXITROL FALCON 062544 AT DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML DEXACIDIN NOVARTIS 064047 AT GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Solution/Drops; Ophthalmic 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN BAUSCH AND LOMB 060582 AT GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Solution/Drops; Ophthalmic 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML NEOSPORIN MONARCH 050218 HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Cream; Topical 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM CORTISPORIN MONARCH 062423 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Solution/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Alcon 064053 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Solution/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE BAUSCH AND LOMB 050479 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Solution/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML CORTISPORIN MONARCH 062874 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Alcon UNIVERSAL 050169 HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Ophthalmic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML CORTISPORIN MONARCH 062488 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE Alcon UNIVERSAL 064065 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML OTICAIR BAUSCH AND LOMB 062822 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML PEDIOTIC MONARCH 060613 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML CORTISPORIN MONARCH 062302 HYDROCORTISONE; POLYMYXIN B SULFATE Solution/Drops; Otic 5MG/ML;EQ 10,000 UNITS BASE/ML OTOBIOTIC SCHERING 060707 NEOMYCIN SULFATE; POLYMYXIN B SULFATE Solution; Irrigation 40MG BASE/ML;200,000 UNITS/ML NEOSPORIN G.U. IRRIGANT MONARCH 050081 NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE Suspension/Drops; Ophthalmic 0.35% BASE;10,000 UNITS/ML;0.5% POLY-PRED ALLERGAN 061015 OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE Ointment; Ophthalmic 5MG BASE/GM;10,000 UNITS/GM TERRAMYCIN W/ POLYMYXIN B SULFATE PFIZER 060716 POLYMYXIN B SULFATE Injection 500,000 U BASE/VIAL POLYMYXIN B SULFATE Bedford 063000 POLYMYXIN B SULFATE Injection 500,000 U BASE/VIAL POLYMYXIN B SULFATE TEK 061578 POLYMYXIN B SULFATE Powder; For Compounding 100,000,000 UNITS/BOT POLY-RX TEK 065006 AT POLYMYXIN B SULFATE; TRIMETHOPRIM Solution/Drops; Ophthalmic 10,000 UNITS/ML;EQ 1MG BASE/ML TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE TAYLOR 050567 AT POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE Solution/Drops; Ophthalmic 10,000 UNITS/ML;EQ 1MG BASE/ML POLYTRIM ALLERGAN 064120 AT POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE Solution/Drops; Ophthalmic 10,000 UNITS/ML;EQ 1MG BASE/ML TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE BAUSCH AND LOMB 064211 AT POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE Solution/Drops; Ophthalmic 10,000 UNITS/ML;EQ 1MG BASE/ML TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE FALCON Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment USP, Akorn, Inc. Cortisporin Ophthalmic Ointment, Monarch Pharmaceuticals Maxitrol (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment), Falcon Pharmaceuticals, Labeling Revision

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