NDA 203076, held by Cipla Ltd. Lamivudine; Nevirapine; Zidovudine.
As of Nov 13, 2026, NDA 203076 (Lamivudine; Nevirapine; Zidovudine), held by Cipla Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 16, 2012 | Original applicationTYPE 3/4 · Standard review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lamivudine; Nevirapine; Zidovudine30MG; 50MG; 60MG · tablet; oral suspension | 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
