Atazanavir Sulfate

Treats HIV-1 infection. ANDA 91673, held by Teva Pharms USA. Atazanavir Sulfate.

As of Nov 15, 2026, ANDA 91673 (Atazanavir Sulfate), held by Teva Pharms USA, was first approved by FDA on Apr 22, 2014, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 22, 2014
Supplements approved: 8
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 capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. Use of atazanavir capsules 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 9 submissions below

Date	Submission	Status	Documents
Apr 22, 2014	Original application	Approved	Letter

Products

4 strengths and forms


Atazanavir SulfateEQ 100MG BASE · capsule;oral	Atazanavir Sulfate	Rx
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 9 submissions, including labeling and manufacturing supplements


Jul 23, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Oct 18, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Oct 18, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Oct 18, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Oct 18, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Oct 18, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Oct 18, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Oct 18, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Apr 22, 2014	Original application	Approved	Letter

Identifiers

Application: ANDA 91673
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals USA

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