Treats secondary hyperparathyroidism. ANDA 213717, held by Eugia Pharma. Doxercalciferol.
As of Nov 14, 2026, ANDA 213717 (Doxercalciferol), held by Eugia Pharma, was first approved by FDA on Jan 24, 2022, with 0 approved supplements and 0 published complete response letters.
Doxercalciferol injection is indicated for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease (CKD) on dialysis. Doxercalciferol is a synthetic vitamin D 2 analog:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 24, 2022 | Original application | Approved | None posted |
| Doxercalciferol2MCG/ML (2MCG/ML) · injectable;injection | Doxercalciferol | Discontinued |
| Doxercalciferol4MCG/2ML (2MCG/ML) · injectable;injection | Doxercalciferol | Discontinued |
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
