FDA.reportPublic FDA data

Application 079233

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53746-458IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-458IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-460IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-460IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-462IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-462IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent