FDA.reportPublic FDA data

Application 209498

Type
ANDA
Sponsor
QILU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MGNoNo
002TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL250MGNoNo
003TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-4666Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateApotex Corp.ANDACurrent
67184-0519Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0519Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0519Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0520Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0520Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0520Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0521Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0521Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0521Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQilu Pharmaceutical Co., Ltd.ANDACurrent
69076-105Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQuinn Pharmaceuticals, LLCANDACurrent
69076-105Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQuinn Pharmaceuticals, LLCANDACurrent
69076-105Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQuinn PharmaceuticalsANDACurrent
69076-105Tenofovir Disoproxil FumarateTenofovir Disoproxil FumarateQuinn PharmaceuticalsANDACurrent