FDA.reportPublic FDA data

Application 205824

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-388EntecavirEntecavirAccord Healthcare Inc.ANDACurrent
16729-388EntecavirEntecavirAccord Healthcare Inc.ANDACurrent
16729-388EntecavirEntecavirAccord Healthcare Inc.ANDACurrent
16729-388EntecavirEntecavirAccord Healthcare Inc.ANDACurrent
16729-389EntecavirEntecavirAccord Healthcare Inc.ANDACurrent
16729-389EntecavirEntecavirAccord Healthcare Inc.ANDACurrent
16729-389EntecavirEntecavirAccord Healthcare Inc.ANDACurrent
16729-389EntecavirEntecavirAccord Healthcare Inc.ANDACurrent
51407-064EntecavirEntecavirGolden State Medical Supply, Inc.ANDACurrent
51407-064EntecavirEntecavirGolden State Medical Supply, Inc.ANDACurrent
51407-064EntecavirEntecavirGolden State Medical Supply, Inc.ANDACurrent
51407-064EntecavirEntecavirGolden State Medical SupplyANDACurrent
51407-064EntecavirEntecavirGolden State Medical Supply Inc.ANDACurrent
51407-065EntecavirEntecavirGolden State Medical Supply Inc.ANDACurrent
51407-065EntecavirEntecavirGolden State Medical Supply, Inc.ANDACurrent
51407-065EntecavirEntecavirGolden State Medical SupplyANDACurrent
51407-065EntecavirEntecavirGolden State Medical Supply, Inc.ANDACurrent
51407-065EntecavirEntecavirGolden State Medical Supply, Inc.ANDACurrent