FDA.reportPublic FDA data

Application 208721

Type
ANDA
Sponsor
BRECKENRIDGE

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
51991-895EntecavirEntecavirBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-895EntecavirEntecavirBreckenridge PharmaceuticANDACurrent
51991-895EntecavirEntecavirBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-895EntecavirEntecavirBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-895EntecavirEntecavirBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-896EntecavirEntecavirBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-896EntecavirEntecavirBreckenridge PharmaceuticANDACurrent
51991-896EntecavirEntecavirBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-896EntecavirEntecavirBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-896EntecavirEntecavirBreckenridge Pharmaceutical, Inc.ANDACurrent