FDA.reportPublic FDA data

Application 071935

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
53746-137IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-137IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-137IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-137IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-137IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent