NDA 219455, held by Fresenius Medcl Care. Sodium Ctirate.
As of Nov 13, 2026, NDA 219455 (Cienby), held by Fresenius Medcl Care, was first approved by FDA on Oct 19, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2026 | Original applicationNew active ingredient · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cienby40G/L trisodium citrate dihydrate (136MMOL/L citrate) · solution; injection | Sodium Ctirate | Rx |
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
