FDA.reportPublic FDA data

Application 208195

Type
ANDA
Sponsor
YUNG SHIN PHARM

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
63126-101EntecavirEntecavirYUNG SHIN PHARM. IND. CO., LTD.ANDACurrent
63126-102EntecavirEntecavirYUNG SHIN PHARM. IND. CO., LTD.ANDACurrent