FDA Approval Activities for this Drug…

Cortisporin Otic (Neomycin and Polymyxin B sulfate and Hydrocortisone) Solution, USP King NDA 50479/S015 Maxitrol (neomycin and polymyxin B sulfates and dexamethasone) Ophthalmic Ointment, Falcon NDA 50-065/S-039 & S-040 Neomycin Sulfate Solution USP, 125 mg/5 mL, Pharma-Tek, ANDA 65-010 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 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 050356 COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE Suspension/Drops; Otic 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML COLY-MYCIN S PARKEDALE 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 060613 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML CORTISPORIN MONARCH 062822 AT HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE Suspension/Drops; Otic 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML PEDIOTIC MONARCH 061579 NEOMYCIN SULFATE Powder; For Compounding 100% NEO-RX TEK 065010 NEOMYCIN SULFATE Solution; 87.5MG BASE/5ML NEO-FRADIN PHARMATEK 060304 NEOMYCIN SULFATE Tablet; 350MG BASE NEOMYCIN SULFATE Teva 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 Cortisporin Ointment (neomycin sulfate, polymyxin B sulfate, bacitracin zinc & hydrocortisone), King 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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