FDA.reportPublic FDA data

Application 064064

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11695-1405NEO-POLY-BACNeomycin sulfate, Polymyxin B Sulfate and Bacitracin ZincButler Animal Health SupplyANDACurrent
13985-746Neomycin and Polymyxin B Sulfates and Bacitracin ZincNeomycin sulfate, Polymyxin B Sulfate and Bacitracin ZincMWIANDACurrent
21695-192Neomycin and Polymyxin B Sulfates and Bacitracin ZincNeomycin sulfate, Polymyxin B Sulfate and Bacitracin ZincRebel Distributors CorpANDACurrent
24208-780Neomycin and Polymyxin B Sulfates and Bacitracin ZincNeomycin sulfate, Polymyxin B Sulfate and Bacitracin ZincBausch & Lomb IncorporatedANDACurrent
24208-780Neomycin and Polymyxin B Sulfates and Bacitracin ZincNeomycin sulfate, Polymyxin B Sulfate and Bacitracin ZincBausch & Lomb IncorporatedANDACurrent
24208-780Neomycin and Polymyxin B Sulfates and Bacitracin ZincNeomycin sulfate, Polymyxin B Sulfate and Bacitracin ZincBausch & Lomb IncorporatedANDACurrent
57319-343Triple AntibioticNeomycin sulfate, Polymyxin B Sulfate and Bacitracin ZincPhoenix Pharmaceutical, Inc.ANDACurrent