Lamivudine

ANDA 202032, held by Aurobindo Pharma Ltd. Lamivudine.

As of Nov 15, 2026, ANDA 202032 (Lamivudine), held by Aurobindo Pharma Ltd, was first approved by FDA on Nov 17, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 17, 2011
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 17, 2011	Original application	Approved	Review

Products

2 strengths and forms


Lamivudine150MG · tablet;oral	Lamivudine	Discontinued
Lamivudine300MG · tablet;oral	Lamivudine	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Sep 24, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Sep 24, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Sep 24, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Sep 24, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Sep 24, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Sep 24, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Mar 31, 2012	Supplement 1Labeling	Approved	None posted
Nov 17, 2011	Original application	Approved	Review

Identifiers

Application: ANDA 202032
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