Treats metabolic acidosis. ANDA 202981, held by Hospira. Sodium Bicarbonate.
As of Nov 15, 2026, ANDA 202981 (Sodium Bicarbonate), held by Hospira, was first approved by FDA on Mar 4, 2016, 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 |
|---|---|---|---|
| Mar 4, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sodium Bicarbonate2.5MEQ/5ML (0.5MEQ/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
