ANDA 219421, held by Alkem Laboratories Limited. Bempedoic Acid, Ezetimibe.
As of Nov 15, 2026, ANDA 219421 (Bempedoic Acid And Ezetimibe), held by Alkem Laboratories Limited, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2025 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bempedoic Acid And Ezetimibe180MG ยท tablet | Bempedoic Acid, Ezetimibe | 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
