FDA.reportPublic FDA data

Application 062341

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MAXITROLDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATESUSPENSION/DROPS;OPHTHALMIC0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-551Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneAidarex Pharmaceuticals LLCANDACurrent
49999-141Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
49999-141Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
49999-141Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-1957Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneA-S Medication SolutionsANDACurrent
50090-3068Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneA-S Medication SolutionsANDACurrent
50090-3068Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneA-S Medication SolutionsANDACurrent
53002-9511Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneRPK Pharmaceuticals, Inc.ANDACurrent
61314-630Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneSandoz Inc.ANDACurrent
61314-630Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneSandoz Inc.ANDACurrent
61314-630Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneSandoz Inc.ANDACurrent
61314-630Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneSandoz Inc.ANDACurrent
68071-3359Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3359Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7686Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9120Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2198Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneREMEDYREPACK INC.ANDACurrent
70518-2198Neomycin and Polymyxin B Sulfates and Dexamethasoneneomycin sulfate, polymyxin b sulfate and dexamethasoneREMEDYREPACK INC.ANDACurrent