Treats hypertension. ANDA 77877, held by Ipca Labs Ltd. Atenolol.
As of Nov 15, 2026, ANDA 77877 (Atenolol), held by Ipca Labs Ltd, was first approved by FDA on Dec 27, 2006, 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 |
|---|---|---|---|
| Dec 27, 2006 | Original application | Approved | None posted |
| Mar 28, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| Mar 20, 2015 | Supplement 3Labeling | Approved | None posted |
| Nov 7, 2014 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 20, 2011 | Supplement 10Labeling | Approved | None posted |
| May 8, 2009 | Supplement 5Labeling | Approved | None posted |
| Dec 27, 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
