Treats secondary hyperparathyroidism. ANDA 205360, held by Avet. Doxercalciferol.
As of Nov 14, 2026, ANDA 205360 (Doxercalciferol), held by Avet, was first approved by FDA on Sep 15, 2020, with 0 approved supplements and 0 published complete response letters.
Doxercalciferol capsules are indicated for the treatment of secondary hyperparathyroidism in adult patients with Stage 3 or Stage 4 chronic kidney disease (CKD) and adult patients with CKD on dialysis. Doxercalciferol Capsules is a synthetic vitamin D 2 analog:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2020 | Original application | Approved | None posted |
| Doxercalciferol0.5MCG · capsule;oral | Doxercalciferol | Rx |
| Doxercalciferol1MCG · capsule;oral | Doxercalciferol | Rx |
| Doxercalciferol2.5MCG · capsule;oral | 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
