NDA 202157, held by Hetero Labs Unit Iii. Lamivudine; Nevirapine; Zidovudine.
As of Nov 14, 2026, NDA 202157 (Lamivudine; Nevirapine; Zidovudine), held by Hetero Labs Unit Iii, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2011 | Original applicationNew formulation or manufacturer · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine; Nevirapine; Zidovudine150MG; 200MG; 300MG · tablet; oral | Lamivudine; Nevirapine; Zidovudine | 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
