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 |
|---|---|---|---|
| Jan 24, 1992 | Original application | Approved | None posted |
| Sep 18, 2024 | Supplement 47Labeling · Standard review | Approved | None posted |
| Jul 1, 2015 | Supplement 35Labeling · Standard review | Approved | None posted |
| Dec 12, 2005 | Supplement 26Labeling | Approved | None posted |
| Feb 6, 2004 | Supplement 24Labeling | Approved | None posted |
| Oct 28, 2003 | Supplement 23Labeling | Approved | None posted |
| Jan 3, 2003 | Supplement 21Manufacturing | Approved | None posted |
| Feb 15, 2001 | Supplement 20Manufacturing | Approved | None posted |
| Aug 10, 2000 | Supplement 19Labeling | Approved | None posted |
| Jun 7, 2000 | Supplement 18Labeling | Approved | None posted |
| Apr 26, 1999 | Supplement 15Labeling | Approved | None posted |
| Apr 26, 1999 | Supplement 14Manufacturing | Approved | None posted |
| Apr 26, 1999 | Supplement 13Manufacturing | Approved | None posted |
| Apr 26, 1999 | Supplement 12Manufacturing | Approved | None posted |
| Apr 5, 1999 | Supplement 17Manufacturing | Approved | None posted |
| Feb 25, 1999 | Supplement 16Labeling | Approved | None posted |
| Aug 14, 1998 | Supplement 11Manufacturing | Approved | None posted |
| Feb 5, 1998 | Supplement 10Manufacturing | Approved | None posted |
| Feb 13, 1997 | Supplement 9Labeling | Approved | None posted |
| Oct 30, 1996 | Supplement 8Manufacturing | Approved | None posted |
| Aug 29, 1994 | Supplement 7Labeling | Approved | None posted |
| Aug 31, 1993 | Supplement 6Labeling | Approved | None posted |
| Feb 8, 1993 | Supplement 4Labeling | Approved | None posted |
| Dec 21, 1992 | Supplement 3Labeling | Approved | None posted |
| Oct 5, 1992 | Supplement 2Labeling | Approved | None posted |
| May 20, 1992 | Supplement 1Labeling | Approved | None posted |
| Jan 24, 1992 | 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
