NDA 208614, held by Hospira. Doxercalciferol.
As of Nov 13, 2026, NDA 208614 (Doxercalciferol), held by Hospira, was first approved by FDA on Jul 24, 2018, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 24, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Doxercalciferol4MCG/2ML (2MCG/ML) · injectable;injection | Doxercalciferol | DiscontinuedReference drug |
| Doxercalciferol10MCG/5ML (2MCG/ML) · injectable;injection | Doxercalciferol | DiscontinuedReference drug |
| Aug 28, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Jul 24, 2018 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
