Entecavir

ANDA 202122, held by Teva Pharms USA. Entecavir.

As of Nov 15, 2026, ANDA 202122 (Entecavir), held by Teva Pharms USA, was first approved by FDA on Aug 26, 2014, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 26, 2014
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 26, 2014	Original application	Approved	Letter

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Jun 16, 2020	Supplement 8Labeling · Standard review	Approved	None posted
May 13, 2019	Supplement 3Labeling · Standard review	Approved	None posted
May 13, 2019	Supplement 5Labeling · Standard review	Approved	None posted
May 13, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Aug 26, 2014	Original application	Approved	Letter

Identifiers

Application: ANDA 202122
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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