Entecavir

Treats chronic hepatitis B virus infection. ANDA 206652, held by Amneal Pharms. Entecavir.

As of Nov 15, 2026, ANDA 206652 (Entecavir), held by Amneal Pharms, was first approved by FDA on Nov 12, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Nov 12, 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
Nov 12, 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 16, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Apr 16, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Sep 30, 2016	Supplement 1Manufacturing	Approved	None posted
Nov 12, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 206652
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals

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