Entecavir

Treats chronic hepatitis B virus infection. ANDA 206217, held by Aurobindo Pharma. Entecavir.

As of Nov 15, 2026, ANDA 206217 (Entecavir), held by Aurobindo Pharma, was first approved by FDA on Aug 26, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Aug 26, 2015
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Aug 26, 2015	Original application	Approved	None posted

Products

2 strengths and forms


Entecavir0.5MG · tablet;oral	Entecavir	Rx
Entecavir1MG · tablet;oral	Entecavir	Rx

All 6 submissions, including labeling and manufacturing supplements


Jun 18, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Mar 10, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Mar 10, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Mar 10, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Mar 10, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Aug 26, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 206217
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters