FDA.reportPublic FDA data

Application 064065

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OTICAIRHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATESUSPENSION/DROPS;OTIC1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-635Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
24208-635Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneBausch & Lomb IncorporatedANDACurrent
49999-439Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin and Polymyxin B Sulfates and HydrocortisoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-0431Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneA-S Medication SolutionsANDACurrent
50090-0431Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneA-S Medication SolutionsANDACurrent
50090-0431Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneA-S Medication SolutionsANDACurrent
50090-0431Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneA-S Medication SolutionsANDACurrent
50436-0737Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneUnit Dose ServicesANDACurrent
52959-084Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneH.J. Harkins Company, Inc.ANDACurrent
53002-9000Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-9000Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneRPK Pharmaceuticals, Inc.ANDACurrent
61919-662NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONENEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEDIRECT RXANDACurrent
61919-662NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONENEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEDIRECT RXANDACurrent
63187-308Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneProficient Rx LPANDACurrent
63187-308Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneProficient Rx LPANDACurrent
63187-308Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneProficient Rx LPANDACurrent
66267-957Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
66267-957Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4229Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4229Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4229Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9924Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9924Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9924Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9924Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0864Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneREMEDYREPACK INC.ANDACurrent
76413-117Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneCentral Texas Community Health CentersANDACurrent