FDA.reportPublic FDA data

Application 202122

Type
ANDA
Sponsor
TEVA PHARMS USA

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
0093-5786EntecavirEntecavirTeva Pharmaceuticals USA,ANDACurrent
0093-5786EntecavirEntecavirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5786EntecavirEntecavirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5786EntecavirEntecavirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5786EntecavirEntecavirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5787EntecavirEntecavirTeva Pharmaceuticals USA,ANDACurrent
0093-5787EntecavirEntecavirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5787EntecavirEntecavirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5787EntecavirEntecavirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5787EntecavirEntecavirTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32181ORIG2014-08-28