FDA.reportPublic FDA data

Application 213497

Type
ANDA
Sponsor
AXUNIO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEFLUNOMIDELEFLUNOMIDETABLET;ORAL10MGNoNo
002LEFLUNOMIDELEFLUNOMIDETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-447LeflunomideleflunomideBurel Pharmaceuticals, LLCANDACurrent
35573-448LeflunomideleflunomideBurel Pharmaceuticals, LLCANDACurrent