Treats HIV-1 infection. ANDA 91168, held by Cipla. Emtricitabine.
As of Nov 15, 2026, ANDA 91168 (Emtricitabine), held by Cipla, was first approved by FDA on Jul 2, 2018, with 2 approved supplements and 0 published complete response letters.
Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 2, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Emtricitabine200MG · capsule;oral | Emtricitabine | Rx |
| Nov 21, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 22, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jul 2, 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
