Lamivudine

Treats chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B…. ANDA 211306, held by Annora. Lamivudine.

As of Nov 15, 2026, ANDA 211306 (Lamivudine), held by Annora, was first approved by FDA on Mar 21, 2019, with 0 approved supplements and 0 published complete response letters.

First approved: Mar 21, 2019
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamivudine tablets (HBV) are indicated for the treatment of chronic hepatitis B virus (HBV) infection associated with evidence of hepatitis B viral replication and active liver inflammation. The following points should be considered when initiating therapy with lamivudine tablets (HBV):

Due to high rates of resistance development in treated patients, initiation of treatment with lamivudine tablets (HBV) should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
Lamivudine tablets (HBV) have not been evaluated in patients co-infected with HIV, hepatitis C virus (HCV), or hepatitis delta virus.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Mar 21, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lamivudine100MG · tablet;oral	Lamivudine	Rx

Identifiers

Application: ANDA 211306
Drugs@FDA: Overview at FDA
Company: Annora 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