Application 206872

Type
ANDA
Sponsor
CIPLA

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
16714-717ENTECAVIRENTECAVIRNorthStar RxLLCANDACurrent
16714-717ENTECAVIRENTECAVIRNorthStar RxLLCANDACurrent
16714-717ENTECAVIRENTECAVIRNorthStar RxLLCANDACurrent
16714-717ENTECAVIRENTECAVIRNorthStar RxLLCANDACurrent
16714-718ENTECAVIRENTECAVIRNorthStar RxLLCANDACurrent
16714-718ENTECAVIRENTECAVIRNorthStar RxLLCANDACurrent
16714-718ENTECAVIRENTECAVIRNorthStar RxLLCANDACurrent
16714-718ENTECAVIRENTECAVIRNorthStar RxLLCANDACurrent
69097-425ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-425ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-425ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-425ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-425ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-426ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-426ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-426ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-426ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent
69097-426ENTECAVIRENTECAVIRCipla USA Inc.ANDACurrent