Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.