Treats hypertension. NDA 219141, held by Novitium Pharma. Hydrochlorothiazide.
As of Nov 14, 2026, NDA 219141 (Inzirqo), held by Novitium Pharma, was first approved by FDA on Jan 28, 2025, with 0 approved supplements and 0 published complete response letters.
INZIRQO (hydrochlorothiazide) is a thiazide diuretic indicated for: The treatment of hypertension in adult and pediatric patients alone or in combination with other antihypertensive agents, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarction. The treatment of edema associated with congestive heart failure, hepatic cirrhosis and renal disease including the nephrotic syndrome in adult and pediatric patients.. 1.1 Hypertension INZIRQO is indicated for the treatment of hypertension in adult and pediatric patients, to lower blood pressure.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Inzirqo10MG/ML · for suspension;oral | Hydrochlorothiazide | 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
