ANDA 78785, held by Emcure Pharma. Atazanavir Sulfate.
As of Nov 15, 2026, ANDA 78785 (Atazanavir Sulfate), held by Emcure Pharma, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 2008 | Original application | Tentative approval |
| Atazanavir Sulfate100MG · capsule; oral | Atazanavir Sulfate | None (tentative approval) |
| Atazanavir Sulfate150MG · capsule; oral | Atazanavir Sulfate | None (tentative approval) |
| Atazanavir Sulfate200MG · capsule; oral | Atazanavir Sulfate | 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
