FDA.reportPublic FDA data

Application 213652

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
50090-5992LeflunomideLeflunomideA-S Medication SolutionsANDACurrent
59651-348LeflunomideLeflunomideAurobindo Pharma LimitedANDACurrent
59651-348LeflunomideLeflunomideAurobindo Pharma LimitedANDACurrent
59651-349LeflunomideLeflunomideAurobindo Pharma LimitedANDACurrent
59651-349LeflunomideLeflunomideAurobindo Pharma LimitedANDACurrent