Lamivudine

Treats human immunodeficiency virus type 1 (HIV-1) infection. ANDA 77464, held by Aurobindo Pharma. Lamivudine.

As of Nov 15, 2026, ANDA 77464 (Lamivudine), held by Aurobindo Pharma, was first approved by FDA on Nov 21, 2016, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 21, 2016
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamivudine tablets are a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.

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
Nov 21, 2016	Original application	Approved	Letter Letter

Products

2 strengths and forms


Lamivudine150MG · tablet;oral	Lamivudine	Rx
Lamivudine300MG · tablet;oral	Lamivudine	Rx

All 4 submissions, including labeling and manufacturing supplements


Sep 26, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Sep 26, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Sep 26, 2019	Supplement 16Labeling · Standard review	Approved	None posted
Nov 21, 2016	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 77464
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