FDA.reportPublic FDA data

Application 064135

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXASPORINDEXAMETHASONE; 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
11695-1403NEO-POLY-DEXNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneButler Animal Health SupplyANDACurrent
13985-028Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneMWI/VetOneANDACurrent
24208-830Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-830Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneBausch & Lomb IncorporatedANDACurrent
45865-796Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and Dexamethasonemedsource pharmaceuticalsANDACurrent
50090-0570Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneA-S Medication SolutionsANDACurrent
50090-0570Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneA-S Medication SolutionsANDACurrent
52959-085Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneH.J. Harkins Company, Inc.ANDACurrent
53002-9510Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneRPK Pharmaceuticals, Inc.ANDACurrent
53002-9510Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneRPK Pharmaceuticals, Inc.ANDACurrent
57319-347Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePhoenix Pharmaceutical, Inc.ANDACurrent
61919-167NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONEDIRECT RXANDACurrent
63187-498Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneProficient Rx LPANDACurrent
63187-498Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneProficient Rx LPANDACurrent
63187-498Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneProficient Rx LPANDACurrent
66267-958Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4375Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4375Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9702Neomycin Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate and DexamethasonePreferred Pharmaceuticals, Inc.ANDACurrent
72189-320NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONEneomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ dropsDirectRxANDACurrent