Treats hypertension. ANDA 73026, held by Pharmobedient. Atenolol.
As of Nov 15, 2026, ANDA 73026 (Atenolol), held by Pharmobedient, was first approved by FDA on Sep 17, 1991, with 33 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Hypertension 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 17, 1991 | Original application | Approved | None posted |
| Aug 29, 2023 | Supplement 48Labeling · Standard review | Approved | None posted |
| Aug 29, 2023 | Supplement 46Labeling · Standard review | Approved | None posted |
| Nov 3, 2014 | Supplement 41Labeling · Standard review | Approved | None posted |
| Nov 30, 2011 | Supplement 40Labeling | Approved | None posted |
| Aug 28, 2008 | Supplement 39Labeling | Approved | None posted |
| Apr 11, 2007 | Supplement 36Labeling | Approved | None posted |
| Apr 19, 2002 | Supplement 28Manufacturing | Approved | None posted |
| Mar 22, 2002 | Supplement 27Manufacturing | Approved | None posted |
| Mar 22, 2002 | Supplement 26Labeling | Approved | None posted |
| Mar 22, 2002 | Supplement 25Manufacturing | Approved | None posted |
| Mar 22, 2002 | Supplement 24Manufacturing | Approved | None posted |
| Aug 7, 2001 | Supplement 23Manufacturing | Approved | None posted |
| Jun 8, 2001 | Supplement 22Manufacturing | Approved | None posted |
| Mar 8, 2001 | Supplement 21Manufacturing | Approved | None posted |
| Jul 24, 2000 | Supplement 20Labeling | Approved | None posted |
| Mar 29, 2000 | Supplement 18Labeling | Approved | None posted |
| May 5, 1999 | Supplement 17Manufacturing | Approved | None posted |
| Apr 27, 1999 | Supplement 16Manufacturing | Approved | None posted |
| Apr 27, 1999 | Supplement 15Manufacturing | Approved | None posted |
| Apr 5, 1999 | Supplement 14Labeling | Approved | None posted |
| Apr 5, 1999 | Supplement 13Manufacturing | Approved | None posted |
| Oct 1, 1997 | Supplement 12Manufacturing | Approved | None posted |
| Aug 13, 1997 | Supplement 10Manufacturing | Approved | None posted |
| Feb 26, 1997 | Supplement 11Labeling | Approved | None posted |
| Mar 1, 1996 | Supplement 9Labeling | Approved | None posted |
| Mar 22, 1995 | Supplement 8Labeling | Approved | None posted |
| Jan 24, 1994 | Supplement 7Manufacturing | Approved | None posted |
| Oct 8, 1993 | Supplement 5Manufacturing | Approved | None posted |
| Sep 8, 1993 | Supplement 6Labeling | Approved | None posted |
| Jul 12, 1993 | Supplement 4Manufacturing | Approved | None posted |
| Apr 7, 1993 | Supplement 3Labeling | Approved | None posted |
| Oct 28, 1992 | Supplement 2Labeling | Approved | None posted |
| May 1, 1992 | Supplement 1Labeling | Approved | None posted |
| Sep 17, 1991 | 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
