Treats human immunodeficiency virus type 1 (HIV-1) infection. ANDA 77695, held by Aurobindo Pharma. Lamivudine.
As of Nov 15, 2026, ANDA 77695 (Lamivudine), held by Aurobindo Pharma, was first approved by FDA on Nov 21, 2016, with 3 approved supplements and 0 published complete response letters.
Lamivudine oral solution is a nucleoside analogue indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 21, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine10MG/ML · solution;oral | Lamivudine | Rx |
| Aug 29, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 29, 2019 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 29, 2019 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 21, 2016 | 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
