Treats secondary hyperparathyroidism. NDA 207174, held by Accord Hlthcare. Paricalcitol.
As of Nov 13, 2026, NDA 207174 (Paricalcitol), held by Accord Hlthcare, was first approved by FDA on Feb 4, 2016, with 1 approved supplement and 0 published complete response letters.
Paricalcitol Injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Paricalcitol0.002MG/ML (0.002MG/ML) · solution;intravenous | Paricalcitol | Rx |
| Paricalcitol0.005MG/ML (0.005MG/ML) · solution;intravenous | Paricalcitol | Rx |
| Paricalcitol0.01MG/2ML (0.005MG/ML) · solution;intravenous | Paricalcitol | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Feb 4, 2016 | 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
