Treats toxemia. ANDA 202561, held by Am Regent. Chlorothiazide Sodium.
As of Nov 15, 2026, ANDA 202561 (Chlorothiazide Sodium), held by Am Regent, was first approved by FDA on Apr 22, 2013, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Chlorothiazide sodium for injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Use in Pregnancy Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chlorothiazide SodiumEQ 500MG BASE/VIAL · injectable;injection | Chlorothiazide Sodium | 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
