FDA.reportPublic FDA data

Application 206217

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
52343-147ENTECAVIRENTECAVIRLUCID PHARMA LLCANDACurrent
52343-147ENTECAVIRENTECAVIRACETRIS HEALTH, LLCANDACurrent
52343-148ENTECAVIRENTECAVIRLUCID PHARMA LLCANDACurrent
52343-148ENTECAVIRENTECAVIRACETRIS HEALTH, LLCANDACurrent
60687-216EntecavirEntecavirAmerican Health PackagingANDACurrent
60687-216EntecavirEntecavirAmerican Health PackagingANDACurrent
60687-216EntecavirEntecavirAmerican Health PackagingANDACurrent
60687-216EntecavirEntecavirAmerican Health PackagingANDACurrent
65862-841EntecavirEntecavirAurobindo Pharma LimitedANDACurrent
65862-841EntecavirEntecavirAurobindo Pharma LimitedANDACurrent
65862-841EntecavirEntecavirAurobindo Pharma LimitedANDACurrent
65862-841EntecavirEntecavirAurobindo Pharma LimitedANDACurrent
65862-842EntecavirEntecavirAurobindo Pharma LimitedANDACurrent
65862-842EntecavirEntecavirAurobindo Pharma LimitedANDACurrent
65862-842EntecavirEntecavirAurobindo Pharma LimitedANDACurrent
65862-842EntecavirEntecavirAurobindo Pharma LimitedANDACurrent