FDA.reportPublic FDA data

Application 208782

Type
ANDA
Sponsor
PRINSTON INC

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
43547-436ENTECAVIRENTECAVIRSolco Healthcare LLCANDACurrent
43547-436ENTECAVIRENTECAVIRSolco Healthcare LLCANDACurrent
43547-436ENTECAVIRENTECAVIRSolco Healthcare LLCANDACurrent
43547-436ENTECAVIRENTECAVIRSolco Healthcare LLCANDACurrent
43547-437ENTECAVIRENTECAVIRSolco Healthcare LLCANDACurrent
43547-437ENTECAVIRENTECAVIRSolco Healthcare LLCANDACurrent
43547-437ENTECAVIRENTECAVIRSolco Healthcare LLCANDACurrent
43547-437ENTECAVIRENTECAVIRSolco Healthcare LLCANDACurrent
50268-289ENTECAVIRENTECAVIRAvPAKANDACurrent
50268-289ENTECAVIRENTECAVIRAvPAKANDACurrent