NDA 206317, held by Rockwell Medical Inc. Ferric Pyrophosphate Citrate.
As of Nov 14, 2026, NDA 206317 (Triferic), held by Rockwell Medical Inc, was first approved by FDA on Jan 23, 2015, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 23, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Triferic27.2MG IRON/5ML (5.44MG IRON/ML) · solution;intravenous | Ferric Pyrophosphate Citrate | DiscontinuedReference drug |
| Triferic272MG IRON/50ML (5.44MG IRON/ML) · solution;intravenous | Ferric Pyrophosphate Citrate | DiscontinuedReference drug |
| Jul 10, 2019 | Supplement 12Labeling · Standard review | Approved | |
| Mar 29, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Oct 16, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Jul 28, 2016 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 16, 2016 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Nov 12, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 10, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 23, 2015 | 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
