Lamivudine

Treats human immunodeficiency virus type 1 (HIV-1) infection. ANDA 90198, held by Macleods Pharms. Lamivudine.

As of Nov 15, 2026, ANDA 90198 (Lamivudine), held by Macleods Pharms, was first approved by FDA on May 1, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: May 1, 2019
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamivudine is 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 2 submissions below

Date	Submission	Status	Documents
May 1, 2019	Original application	Approved	Letter

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Jun 11, 2020	Supplement 14Labeling · Standard review	Approved	None posted
May 1, 2019	Original application	Approved	Letter

Identifiers

Application: ANDA 90198
Drugs@FDA: Overview at FDA
Company: Macleods Pharmaceuticals

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