Treats metabolic acidosis. ANDA 211091, held by Exela Pharma. Sodium Bicarbonate.
As of Nov 15, 2026, ANDA 211091 (Sodium Bicarbonate), held by Exela Pharma, was first approved by FDA on Jun 20, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2019 | Original application | Approved | None posted |
| Sodium Bicarbonate5MEQ/10ML (0.5MEQ/ML) · solution;intravenous | Sodium Bicarbonate | Rx |
| Sodium Bicarbonate44.6MEQ/50ML (0.9MEQ/ML) · solution;intravenous | Sodium Bicarbonate | Rx |
| Sodium Bicarbonate10MEQ/10ML (1MEQ/ML) · solution;intravenous | Sodium Bicarbonate | Rx |
| Sodium Bicarbonate50MEQ/50ML (1MEQ/ML) · solution;intravenous | Sodium Bicarbonate | 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
