Treats hypertension. ANDA 78512, held by Aurobindo Pharma. Atenolol.
As of Nov 15, 2026, ANDA 78512 (Atenolol), held by Aurobindo Pharma, was first approved by FDA on Oct 31, 2007, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hypertension Atenolol tablets 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 |
|---|---|---|---|
| Oct 31, 2007 | Original application | Approved | None posted |
| Mar 29, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| May 27, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 17, 2012 | Supplement 4Manufacturing | Approved | None posted |
| Oct 18, 2011 | Supplement 5Labeling | Approved | None posted |
| Sep 2, 2009 | Supplement 2Labeling | Approved | None posted |
| Oct 31, 2007 | 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
