Treats human immunodeficiency virus type 1 (HIV-1) infection. ANDA 91606, held by Apotex. Lamivudine.
As of Nov 15, 2026, ANDA 91606 (Lamivudine), held by Apotex, was first approved by FDA on Dec 2, 2011, with 9 approved supplements and 0 published complete response letters.
Lamivudine tablets are 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 |
|---|---|---|---|
| Dec 2, 2011 | Original application | Approved | None posted |
| Lamivudine150MG · tablet;oral | Lamivudine | Rx |
| Lamivudine300MG · tablet;oral | Lamivudine | Rx |
| Oct 3, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 3, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 31, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 31, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| Dec 31, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 31, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 31, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 2, 2011 | 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
