NDA 205508, held by Emcure Pharms Ltd. Atazanavir Sulfate; Ritonavir.
As of Nov 15, 2026, NDA 205508 (Atazanavir Sulfate; Ritonavir), held by Emcure Pharms Ltd, was not approved, with 0 approved supplements and 1 published complete response letter.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2014 | Original applicationNew combination · Priority review | Tentative approval |
| Letter | Product | Now |
|---|---|---|
| Jul 28, 2025 | NDA 205508Facility Inspections, Bioequivalence/Bioavailability, Product | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atazanavir Sulfate; Ritonavir300MG; 100MG · tablet; oral | Atazanavir Sulfate; 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
