ANDA 91475, held by Hetero Labs Ltd Iii. Lamivudine.
As of Nov 15, 2026, ANDA 91475 (Lamivudine), held by Hetero Labs Ltd Iii, was first approved by FDA on Oct 6, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine10MG/ML ยท solution;oral | Lamivudine | 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
