Entecavir

ANDA 208721, held by Breckenridge. Entecavir.

As of Nov 14, 2026, ANDA 208721 (Entecavir), held by Breckenridge, was first approved by FDA on Mar 15, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 15, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 15, 2018	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Nov 13, 2020	Supplement 2Labeling · Standard review	Approved	None posted
May 13, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Mar 15, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 208721
Drugs@FDA: Overview at FDA
Company: Breckenridge Pharmaceutical

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