Manages hypertension. ANDA 213412, held by Alkem Labs Ltd. Chlorthalidone.
As of Nov 15, 2026, ANDA 213412 (Chlorthalidone), held by Alkem Labs Ltd, was first approved by FDA on Feb 11, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 11, 2020 | Original application | Approved | None posted |
| Chlorthalidone25MG · tablet;oral | Chlorthalidone | Rx |
| Chlorthalidone50MG · tablet;oral | Chlorthalidone | 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
