FDA approves Amneal's sodium bicarbonate injection NDA220790

The U.S. Food and Drug Administration approved NDA220790 for sodium bicarbonate, an intravenous solution sponsored by Amneal, with a submission status date of July 9, 2026. The product is listed as a solution administered by the intravenous route, with a brand name of Sodium Bicarbonate and an active ingredient strength of 150MEQ/1000ML (0.15MEQ/ML).¹

The application was reviewed under standard review priority and was classified as an original submission (ORIG 1), submission number 1. The submission class is designated as Type 5, New Formulation or New Manufacturer.¹

According to the FDA's application documents, an approval letter was issued dated July 10, 2026, and the product label was posted on July 16, 2026. Both documents are hosted on the FDA's Drugs@FDA site under application number 220790.¹

The submission status is recorded as "AP," indicating the application was approved. The full application record can be found on the FDA's Drugs@FDA database under application number NDA220790.¹

No additional details on indication, dosing regimen, or clinical trial data supporting the approval were included in the available FDA records reviewed for this report.