Treats hypertension. NDA 220256, held by Azurity. Clonidine Hydrochloride.
As of Nov 13, 2026, NDA 220256 (Javadin), held by Azurity, was first approved by FDA on Oct 23, 2025, with 0 approved supplements and 0 published complete response letters.
JAVADIN is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure reduces 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. There are no controlled trials demonstrating risk reduction with JAVADIN. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2025 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Javadin0.02MG/ML · solution;oral | Clonidine Hydrochloride | 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
