FDA.reportPublic FDA data

Application 062488

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONEHYDROCORTISONE; 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
50090-2365Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneA-S Medication SolutionsANDACurrent
61314-645Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneSandoz Inc.ANDACurrent
61314-645Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneSandoz Inc.ANDACurrent
61314-645Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneSandoz Inc.ANDACurrent
61314-645Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneSandoz Inc.ANDACurrent
63187-648Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneProficient Rx LPANDACurrent
63187-648Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneProficient Rx LPANDACurrent
63187-648Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneProficient Rx LPANDACurrent
63187-648Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneProficient Rx LPANDACurrent
63629-8844Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneBryant Ranch PrepackANDACurrent
63629-8844Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneBryant Ranch PrepackANDACurrent
68071-4577Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7684Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-8130Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisonePreferred Pharmaceuticals Inc.ANDACurrent
68788-9415Neomycin and Polymyxin B Sulfates and Hydrocortisoneneomycin sulfate, polymyxin b sulfate and hydrocortisonePreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22270ORIG2002-07-16