Treats HIV-1 infection. ANDA 212579, held by Laurus. Atazanavir Sulfate.
As of Nov 15, 2026, ANDA 212579 (Atazanavir Sulfate), held by Laurus, was first approved by FDA on Apr 30, 2021, with 1 approved supplement and 0 published complete response letters.
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 of age and older weighing at least 15 kg. Limitations of Use: Atazanavir is 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2021 | Original application | Approved | None posted |
| 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 |
| Jun 21, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 30, 2021 | Original application | Approved | None posted |
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
