FDA.reportPublic FDA data

Application 064047

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINGRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATESOLUTION/DROPS;OPHTHALMIC0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-528Neomycin and Polymyxin B Sulfates and GramicidinNeomycin sulfate, Polymyxin B Sulfate and GramicidinRebel Distributors CorpANDACurrent
24208-790NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINneomycin sulfate, polymyxin b sulfate and gramicidinBausch & Lomb IncorporatedANDACurrent
24208-790NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINneomycin sulfate, polymyxin b sulfate and gramicidinBausch & Lomb IncorporatedANDACurrent
24208-790NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINneomycin sulfate, polymyxin b sulfate and gramicidinBausch & Lomb IncorporatedANDACurrent
50090-0247NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINneomycin sulfate, polymyxin b sulfate and gramicidinA-S Medication SolutionsANDACurrent
50090-0247NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINneomycin sulfate, polymyxin b sulfate and gramicidinA-S Medication SolutionsANDACurrent
50090-0247NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINneomycin sulfate, polymyxin b sulfate and gramicidinA-S Medication SolutionsANDACurrent
50090-0247NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINneomycin sulfate, polymyxin b sulfate and gramicidinA-S Medication SolutionsANDACurrent
55045-1194NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDINneomycin sulfate, polymyxin b sulfate and gramicidinDispensing Solutions, Inc.ANDACurrent