Treats hypertension. NDA 214439, held by Cmp Dev LLC. Amlodipine Besylate.
As of Nov 13, 2026, NDA 214439 (Norliqva), held by Cmp Dev LLC, was first approved by FDA on Feb 24, 2022, with 1 approved supplement and 1 published complete response letter.
NORLIQVA is a calcium channel blocker for the treatment of: Hypertension NORLIQVA is indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40% 1.1 Hypertension NORLIQVA is indicated for the treatment of hypertension, to lower blood pressure in adults and children 6 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 24, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Apr 22, 2021 | NORLIQVA (amlodipine)Facility Inspections, Additional Product Quality Comment | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| NorliqvaEQ 1MG BASE/ML · solution;oral | Amlodipine Besylate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 2, 2026 | Supplement 1Labeling · Standard review | Approved | |
| Feb 24, 2022 | Original applicationNew formulation or manufacturer · 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
