ANDA 220238, held by Qilu Pharmaceutical Co., Ltd.. Abemaciclib.
As of Nov 13, 2026, ANDA 220238 (Abemaciclib), held by Qilu Pharmaceutical Co., Ltd., was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 6, 2025 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Abemaciclib150MG · tablet | Abemaciclib | None (tentative approval) |
| Abemaciclib100MG · tablet | Abemaciclib | None (tentative approval) |
| Abemaciclib50MG · tablet | Abemaciclib | None (tentative approval) |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
