ANDA 91101, held by Hikma. Doxercalciferol.
As of Nov 14, 2026, ANDA 91101 (Doxercalciferol), held by Hikma, was first approved by FDA on Aug 30, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2013 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Doxercalciferol4MCG/2ML (2MCG/ML) ยท injectable;injection | Doxercalciferol | 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
