INDICATIONS & USAGE Atenolol tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 including atenolol. 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 |
|---|---|---|---|
| Sep 13, 2006 | Original application | Approved | None posted |
| Jul 30, 2025 | Supplement 16Labeling · Standard review | Approved | None posted |
| Nov 4, 2014 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 28, 2011 | Supplement 3Labeling | Approved | None posted |
| Jul 6, 2010 | Supplement 2Labeling | Approved | None posted |
| Sep 13, 2006 | Original application | Approved | None posted |
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
