NDA 220381, held by Fresenius Kabi USA. Sodium Glycerophosphate.
As of Nov 13, 2026, NDA 220381 (Glycophos), held by Fresenius Kabi USA, was first approved by FDA on Jul 29, 2026, with 0 approved supplements and 0 published complete response letters.
Glycophos is indicated as a source of phosphorus in adults and pediatric patients 12 years and older as part of parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2026 | Original applicationNew active ingredient · Standard review | Approved |
| Glycophos4.32GM/20ML (216MG/ML) · solution;intravenous | Sodium Glycerophosphate | RxReference drug |
| Glycophos21.6GM/100ML (216MG/ML) · solution;intravenous | Sodium Glycerophosphate | RxReference drug |
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
