Treats hypertension. NDA 211340, held by Azurity. Amlodipine Benzoate.
As of Nov 13, 2026, NDA 211340 (Katerzia), held by Azurity, was first approved by FDA on Jul 8, 2019, with 1 approved supplement and 0 published complete response letters.
KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension KATERZIA is indicated for the treatment of hypertension in adults and children 6 years 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
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 8, 2019 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| KaterziaEQ 1MG BASE/ML · suspension;oral | Amlodipine Benzoate | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2021 | Supplement 1Manufacturing | Approved | |
| Jul 8, 2019 | 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
