NDA 201657, held by Hospira. Paricalcitol.
As of Nov 13, 2026, NDA 201657 (Paricalcitol), held by Hospira, was first approved by FDA on Oct 21, 2014, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2014 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paricalcitol0.002MG/ML (0.002MG/ML) · solution;intravenous | Paricalcitol | Discontinued |
| Paricalcitol0.005MG/ML (0.005MG/ML) · solution;intravenous | Paricalcitol | Discontinued |
| Paricalcitol0.01MG/2ML (0.005MG/ML) · solution;intravenous | Paricalcitol | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Jan 11, 2017 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| May 14, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 24, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 21, 2014 | 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
