ANDA 214263, held by Zydus Pharms USA Inc. Osimertinib Mesylate.
As of Nov 15, 2026, ANDA 214263 (Osimertinib Mesylate), held by Zydus Pharms USA Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2021 | Original application | Tentative approval |
| Osimertinib Mesylate40MG · tablet;oral | Osimertinib Mesylate | None (tentative approval) |
| Osimertinib Mesylate80MG · tablet;oral | Osimertinib Mesylate | 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
