NDA 205425, held by Cipla Ltd. Lopinavir;Ritonavir.
As of Nov 14, 2026, NDA 205425 (Lopinavir And Ritonavir), held by Cipla Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 21, 2015 | Original applicationNew formulation or manufacturer · Priority review | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lopinavir And Ritonavir40MG;10MG · pellets;oral | Lopinavir;Ritonavir | 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
