Treats secondary hyperparathyroidism. ANDA 210452, held by Gland. Doxercalciferol.
As of Nov 14, 2026, ANDA 210452 (Doxercalciferol), held by Gland, was first approved by FDA on Sep 26, 2019, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 26, 2019 | Original application | Approved |
| 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
