NDA 21943, held by Aurobindo Pharma Ltd. Lamivudine; Zidovudine; Efavirenz.
As of Nov 14, 2026, NDA 21943 (Lamivudine; Zidovudine), held by Aurobindo Pharma Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2006 | Original applicationNew combination · Priority review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine; Zidovudine150MG; 300MG; 600MG · tablet; oral | Lamivudine; Zidovudine; Efavirenz | None (tentative approval) |
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
