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# Hydrochlorothiazide Not Withdrawn Over Safety/Efficacy
- URL: https://www.fdaweb.com/hydrochlorothiazide-not-withdrawn-over-safety-efficacy/
- Published: 2023-05-11T12:00:00.000Z
- Updated: 2026-09-14T18:31:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154426

*Federal Register* notice: FDA has determined that Roxane Laboratories’ hydrochlorothiazide oral solution, 50 mg/5 mL was not withdrawn from sale due to safety or effectiveness concerns. The determination allows the agency to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Hydrochlorothiazide is indicated for: (**1**) adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy; (**2**) edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure; and (**3**) managing hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-11/pdf/2023-10052.pdf?ref=fdaweb.com).