Manages secondary hyperparathyroidism and resultant metabolic bone disease. ANDA 91356, held by Onesource Specialty. Calcitriol.
As of Nov 15, 2026, ANDA 91356 (Calcitriol), held by Onesource Specialty, was first approved by FDA on Dec 12, 2014, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Predialysis Patients Calcitriol capsule is indicated in the management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (Ccr 15 to 55 mL/min) not yet on dialysis. In children, the creatinine clearance value must be corrected for a surface area of 1.73 square meters. A serum iPTH level of ≥ 100 pg/mL is strongly suggestive of secondary hyperparathyroidism. Dialysis Patients Calcitriol capsule is indicated in the management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 12, 2014 | Original application | Approved | None posted |
| Calcitriol0.25MCG · capsule;oral | Calcitriol | Rx |
| Calcitriol0.5MCG · capsule;oral | Calcitriol | Rx |
| Sep 16, 2026 | Supplement 11Manufacturing | Approved | None posted |
| Dec 12, 2014 | Original application | Approved | None posted |
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
