FDA.reportPublic FDA data

Application 064063

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11695-1436NEO-POLY-DEXNeomycin sulfate, Polymyxin B Sulfate, and DexamethasoneButler Animal Health SupplyANDACurrent
13985-014Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin sulfate, Polymyxin B Sulfate, and DexamethasoneMWI/VetOneANDACurrent
13985-744Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneMWIANDACurrent
24208-795Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-795Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-795Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneBausch & Lomb IncorporatedANDACurrent
24208-795Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneBausch & Lomb IncorporatedANDACurrent
50090-6181Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneA-S Medication SolutionsANDACurrent
57319-307NPDNeomycin sulfate, Polymyxin B Sulfate, and DexamethasonePhoenix Pharmaceutical, Inc.ANDACurrent
63187-669Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneProficient Rx LPANDACurrent
63187-669Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneProficient Rx LPANDACurrent
63187-669Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneProficient Rx LPANDACurrent
68071-2428Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6841Neomycin and Polymyxin B Sulfates and DexamethasoneNeomycin Sulfate, Polymyxin B Sulfate, and DexamethasonePreferred Pharmaceuticals Inc.ANDACurrent
80425-0229NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent