FDA.reportPublic FDA data

Application 207095

Type
ANDA
Sponsor
SHANDONG XINHUA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo
002IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11788-003IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-003IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-005IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-005IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-007IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-007IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
58624-7007IbuprofenIbuprofenShandong Xinhua Pharmaceutical Co., Ltd.ANDACurrent
58624-7008IbuprofenIbuprofenShandong Xinhua Pharmaceutical Co., Ltd.ANDACurrent
58624-7009IbuprofenIbuprofenShandong Xinhua Pharmaceutical Co., Ltd.ANDACurrent
58624-7010IbuprofenIbuprofenShandong Xinhua Pharmaceutical Co., Ltd.ANDACurrent
58624-7011IbuprofenIbuprofenShandong Xinhua Pharmaceutical Co., Ltd.ANDACurrent
58624-7012IbuprofenIbuprofenShandong Xinhua Pharmaceutical Co., Ltd.ANDACurrent