Atazanavir Sulfate

Treats HIV-1 infection. ANDA 212278, held by Hetero Labs Ltd Iii. Atazanavir Sulfate.

As of Nov 15, 2026, ANDA 212278 (Atazanavir Sulfate), held by Hetero Labs Ltd Iii, was first approved by FDA on Feb 2, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 2, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use:

Atazanavir are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus.
Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions.

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
Feb 2, 2022	Original application	Approved	None posted

Products

3 strengths and forms


Atazanavir SulfateEQ 150MG BASE · capsule;oral	Atazanavir Sulfate	Rx
Atazanavir SulfateEQ 200MG BASE · capsule;oral	Atazanavir Sulfate	Rx
Atazanavir SulfateEQ 300MG BASE · capsule;oral	Atazanavir Sulfate	Rx

All 2 submissions, including labeling and manufacturing supplements


May 8, 2025	Supplement 2Labeling · Standard review	Approved	None posted
Feb 2, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 212278
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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