FDA.reportPublic FDA data

Application 062166

Type
ANDA
Sponsor
PERRIGO CO TENNESSEE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATEBACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATEOINTMENT;OPHTHALMIC400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GMNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0574-4144Neo Polycin HCneomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone acetatePaddock Laboratories, LLCANDACurrent
0574-4144Neo Polycin HCneomycin and polymyxin b sulfates, bacitracin zinc and hydrocortisone acetatePadagis US LLCANDACurrent
21695-736Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone AcetateNeomycin sulfate and Polymyxin B Sulfate, Bacitracin zinc and Hydrocortisone AcetateRebel Distributors CorpANDACurrent