NDA 218343, held by Amneal. Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic.
As of Nov 13, 2026, NDA 218343 (Potassium Phosphates In 0.9% Sodium Chloride), held by Amneal, was first approved by FDA on Jul 26, 2024, with 0 approved supplements and 0 published complete response letters.
Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Potassium Phosphates In 0.9% Sodium Chloride1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) · solution;intravenous | Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic | 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
