Treats secondary hyperparathyroidism. ANDA 215810, held by Alembic. Doxercalciferol.
As of Nov 14, 2026, ANDA 215810 (Doxercalciferol), held by Alembic, was first approved by FDA on Jun 15, 2023, with 0 approved supplements and 0 published complete response letters.
Doxercalciferol Injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis Doxercalciferol is a synthetic vitamin D 2 analog:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 15, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Doxercalciferol4MCG/2ML (2MCG/ML) · injectable;injection | Doxercalciferol | Rx |
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
