Treats hypertension. NDA 208401, held by Azurity. Lisinopril.
As of Nov 13, 2026, NDA 208401 (Qbrelis), held by Azurity, was first approved by FDA on Jul 29, 2016, with 1 approved supplement and 0 published complete response letters.
QBRELIS is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older. Adjunct therapy for heart failure. Treatment of Acute Myocardial Infarction. 1.1 Hypertension QBRELIS is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Qbrelis1MG/ML · solution;oral | Lisinopril | RxReference drug |
| Jul 28, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Jul 29, 2016 | Original applicationNew dosage form · Standard review | Approved |
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
