Application Nr Approved Date Route Status External Links
ANDA206217 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Entecavir Tablets Are Indicated For The Treatment Of Chronic Hepatitis B Virus Infection In Adults And Pediatric Patients 2 Years Of Age And Older With Evidence Of Active Viral Replication And Either Evidence Of Persistent Elevations In Serum Aminotransferases (Alt Or Ast) Or Histologically Active Disease. The Following Points Should Be Considered When Initiating Therapy With Entecavir Tablets: In Adult Patients, This Indication Is Based On Clinical Trial Data In Nucleoside-Inhibitor-Treatment-Naïve And Lamivudine-Resistant Subjects With Hbeag-Positive And Hbeag-Negative Hbv Infection And Compensated Liver Disease And A More Limited Number Of Subjects With Decompensated Liver Disease. [See Clinical Studies (14.1) ] . In Pediatric Patients 2 Years Of Age And Older, This Indication Is Based On Clinical Trial Data In Nucleoside-Inhibitor-Treatment-Naïve And In A Limited Number Of Lamivudine-Experienced Subjects With Hbeag-Positive Chronic Hbv Infection And Compensated Liver Disease [See Clinical Studies (14.2) ]. Entecavir Is A Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Indicated For The Treatment Of Chronic Hepatitis B Virus Infection In Adults And Children At Least 2 Years Of Age With Evidence Of Active Viral Replication And Either Evidence Of Persistent Elevations In Serum Aminotransferases (Alt Or Ast) Or Histologically Active Disease.( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Entecavir ENTECAVIR ZINC3802690

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