FDA.reportPublic FDA data

Application 072199

Type
ANDA
Sponsor
AMNEAL PHARMS NY

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30142-167IbuprofenIbuprofenThe Kroger Co.ANDACurrent
53746-142IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-142IbuprofenIbuprofenAmneal PharmaceuticalsANDACurrent
53746-142IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-144IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
53746-144IbuprofenIbuprofenAmneal PharmaceuticalsANDACurrent
53746-144IbuprofenIbuprofenAmneal Pharmaceuticals of New York LLCANDACurrent
59726-167Pain ReliefIbuprofenP and L Development of New York CorporationANDACurrent