Treats HIV-1 infection. ANDA 79188, held by Aurobindo Pharma Ltd. Emtricitabine.
As of Nov 15, 2026, ANDA 79188 (Emtricitabine), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 15, 2023, with 0 approved supplements and 0 published complete response letters.
Emtricitabine capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Emtricitabine200MG · capsule;oral | Emtricitabine | Rx |
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
