FDA.reportPublic FDA data

Application 209613

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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
69238-1303TeriflunomideTeriflunomideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1303TeriflunomideTeriflunomideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1303TeriflunomideTeriflunomideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1303TeriflunomideTeriflunomideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1303TeriflunomideTeriflunomideAmneal Pharmaceuticals LLCANDACurrent
69238-1304TeriflunomideTeriflunomideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1304TeriflunomideTeriflunomideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1304TeriflunomideTeriflunomideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1304TeriflunomideTeriflunomideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1304TeriflunomideTeriflunomideAmneal Pharmaceuticals LLCANDACurrent