FDA.reportPublic FDA data

Application 064068

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEBACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11695-1406NEO-POLY-BAC HYDRONeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneButler Animal Health SupplyANDACurrent
13985-016Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneMWI/VetOneANDACurrent
13985-745Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneMWIANDACurrent
24208-785Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
24208-785Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
24208-785Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
24208-785Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and HydrocortisoneNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
57319-344Triple Antibiotic HCNeomycin sulfate and Polymyxin B Sulfate, Bacitracin Zinc and HydrocortisonePhoenix Pharmaceutical, Inc.ANDACurrent