FDA.reportPublic FDA data

Application 209663

Type
ANDA
Sponsor
GLENMARK PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERIFLUNOMIDETERIFLUNOMIDETABLET;ORAL7MGNoNo
002TERIFLUNOMIDETERIFLUNOMIDETABLET;ORAL14MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-311teriflunomideteriflunomideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-311teriflunomideteriflunomideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-311teriflunomideteriflunomideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-311teriflunomideteriflunomideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-312teriflunomideteriflunomideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-312teriflunomideteriflunomideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-312teriflunomideteriflunomideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-312teriflunomideteriflunomideGlenmark Pharmaceuticals Inc., USAANDACurrent