FDA.reportPublic FDA data

Application 064053

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEHYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATESOLUTION/DROPS;OTIC1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-912Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneBlenheim Pharmacal, IncANDACurrent
21695-437Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneRebel Distributors CorpANDACurrent
21695-438Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and HydrocortisoneRebel Distributors CorpANDACurrent
24208-631Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneBausch & Lomb IncoporatedANDACurrent
24208-631Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneBausch & Lomb IncoporatedANDACurrent
24208-631Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneBausch & Lomb IncoporatedANDACurrent
49999-254Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0433Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneA-S Medication SolutionsANDACurrent
53002-9061Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-9061Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneRPK Pharmaceuticals, Inc.ANDACurrent
63187-270Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneProficient Rx LPANDACurrent
63187-270Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneProficient Rx LPANDACurrent
66267-954Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneNuCare Pharmaceuticals, Inc.ANDACurrent
66267-954Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4174Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4174Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0763Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneREMEDYREPACK INC.ANDACurrent
70518-0763Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneREMEDYREPACK INC.ANDACurrent
70518-0763Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneREMEDYREPACK INC.ANDACurrent
70518-0763Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneREMEDYREPACK INC.ANDACurrent
70518-0763Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneREMEDYREPACK INC.ANDACurrent
70518-0763Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneREMEDYREPACK INC.ANDACurrent
76420-104Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin Sulfate, Polymyxin B Sulfate, HydrocortisoneAsclemed USA, Inc.ANDACurrent