Treats primary disease. ANDA 211558, held by B Braun Medical. Tromethamine.
As of Nov 15, 2026, ANDA 211558 (Tromethamine), held by B Braun Medical, was first approved by FDA on Dec 9, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Tromethamine Injection is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease: Metabolic Acidosis Associated with Cardiac Bypass Surgery. Tromethamine Injection has been found to be primarily beneficial in correcting metabolic acidosis which may occur during or immediately following cardiac bypass surgical procedures. Correction of Acidity of ACD Blood in Cardiac Bypass Surgery. It is well known that ACD blood is acidic and becomes more acidic on storage. Tromethamine effectively corrects this acidity.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tromethamine18GM/500ML (3.6GM/100ML) · solution;injection | Tromethamine | 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
