ANDA 75816, held by Hospira. Calcitriol.
As of Nov 15, 2026, ANDA 75816 (Calcitriol), held by Hospira, was first approved by FDA on Jan 16, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2004 | Original application | Approved | None posted |
| Calcitriol0.001MG/ML · injectable;injection | Calcitriol | Discontinued |
| Calcitriol0.002MG/ML · injectable;injection | Calcitriol | 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