For clinically significant metabolic acidosis. NDA 220790, held by Amneal. Sodium Bicarbonate.
As of Nov 13, 2026, NDA 220790 (Sodium Bicarbonate), held by Amneal, was first approved by FDA on Jul 9, 2026, with 0 approved supplements and 0 published complete response letters.
Sodium bicarbonate injection is an alkalinizing agent indicated: to raise plasma pH in adults and pediatric patients with clinically significant metabolic acidosis. to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2026 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Bicarbonate150MEQ/1000ML (0.15MEQ/ML) · solution;intravenous | Sodium Bicarbonate | 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
