FDA.reportPublic FDA data

Application 206745

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENTECAVIRENTECAVIRTABLET;ORAL0.5MGNoNo
002ENTECAVIRENTECAVIRTABLET;ORAL1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-920EntecavirEntecavirZydus Pharmaceuticals USA Inc.ANDACurrent
68382-920EntecavirEntecavirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-920EntecavirEntecavirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-920EntecavirEntecavirZydus Pharmaceuticals USA Inc.ANDACurrent
68382-921EntecavirEntecavirZydus Pharmaceuticals USA Inc.ANDACurrent
68382-921EntecavirEntecavirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-921EntecavirEntecavirZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-921EntecavirEntecavirZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1019EntecavirEntecavirCadila Healthcare LimitedANDACurrent
70771-1019EntecavirEntecavirCadila Healthcare LimitedANDACurrent
70771-1019EntecavirEntecavirZydus Lifesciences LimitedANDACurrent
70771-1020EntecavirEntecavirCadila Healthcare LimitedANDACurrent
70771-1020EntecavirEntecavirCadila Healthcare LimitedANDACurrent
70771-1020EntecavirEntecavirZydus Lifesciences LimitedANDACurrent