FDA.reportPublic FDA data

Application 206652

Type
ANDA
Sponsor
AMNEAL 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
10135-615EntecavirEntecavirMarlex Pharmaceuticals IncANDACurrent
10135-616EntecavirEntecavirMarlex Pharmaceuticals IncANDACurrent
42291-261EntecavirEntecavirAvKARE, Inc.ANDACurrent
42291-261EntecavirEntecavirAvKAREANDACurrent
42291-261EntecavirEntecavirAvKAREANDACurrent
42291-261EntecavirEntecavirAvKAREANDACurrent
42291-261EntecavirEntecavirAvKAREANDACurrent
42291-262EntecavirEntecavirAvKAREANDACurrent
42291-262EntecavirEntecavirAvKAREANDACurrent
42291-262EntecavirEntecavirAvKAREANDACurrent
42291-262EntecavirEntecavirAvKAREANDACurrent
42291-262EntecavirEntecavirAvKARE, Inc.ANDACurrent
65162-446EntecavirEntecavirAmneal Pharmaceuticals LLCANDACurrent
65162-446EntecavirEntecavirAmneal Pharmaceuticals LLCANDACurrent
65162-446EntecavirEntecavirAmneal Pharmaceuticals LLCANDACurrent
65162-446EntecavirEntecavirAmneal Pharmaceuticals LLCANDACurrent
65162-449EntecavirEntecavirAmneal Pharmaceuticals LLCANDACurrent
65162-449EntecavirEntecavirAmneal Pharmaceuticals LLCANDACurrent
65162-449EntecavirEntecavirAmneal Pharmaceuticals LLCANDACurrent
65162-449EntecavirEntecavirAmneal Pharmaceuticals LLCANDACurrent