Manages hypocalcemia. ANDA 211030, held by Gland. Calcitriol.
As of Nov 15, 2026, ANDA 211030 (Calcitriol), held by Gland, was first approved by FDA on Feb 3, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Calcitriol injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 3, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Calcitriol0.001MG/ML · injectable;injection | Calcitriol | 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
