Treats hypertension. NDA 218647, held by Prm Pharma. Chlorthalidone.
As of Nov 13, 2026, NDA 218647 (Hemiclor), held by Prm Pharma, was first approved by FDA on Mar 17, 2025, with 0 approved supplements and 0 published complete response letters.
HEMICLOR is a thiazide-like diuretic indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hemiclor12.5MG · tablet;oral | Chlorthalidone | RxReference drug |
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
