Entecavir

Treats chronic hepatitis B virus infection. ANDA 206872, held by Cipla. Entecavir.

As of Nov 15, 2026, ANDA 206872 (Entecavir), held by Cipla, was first approved by FDA on Dec 6, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 6, 2016
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Entecavir tablet is a hepatitis B virus nucleoside analogue 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 6, 2016	Original application	Approved	None posted

Products

2 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Jun 18, 2020	Supplement 4Labeling · Standard review	Approved	None posted
May 13, 2019	Supplement 2Labeling · Standard review	Approved	None posted
May 13, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Dec 6, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206872
Drugs@FDA: Overview at FDA
Company: Cipla

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