Treats HIV-1 infection. ANDA 204806, held by Aurobindo Pharma. Atazanavir Sulfate.
As of Nov 15, 2026, ANDA 204806 (Atazanavir Sulfate), held by Aurobindo Pharma, was first approved by FDA on Jun 25, 2018, with 3 approved supplements and 0 published complete response letters.
Atazanavir capsule is 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2018 | Original application | Approved |
| 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 |
| Jun 26, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 21, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jun 21, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jun 25, 2018 | Original application | Approved |
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
