Atenolol

Treats hypertension. ANDA 76900, held by Zydus Pharms USA. Atenolol.

As of Nov 15, 2026, ANDA 76900 (Atenolol), held by Zydus Pharms USA, was first approved by FDA on Jan 28, 2005, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2005
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hypertension Atenolol is 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Jan 28, 2005	Original application	Approved	None posted

Products

3 strengths and forms


Atenolol25MG · tablet;oral	Atenolol	Rx
Atenolol50MG · tablet;oral	Atenolol	Rx
Atenolol100MG · tablet;oral	Atenolol	Rx

All 13 submissions, including labeling and manufacturing supplements


Mar 28, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Oct 31, 2014	Supplement 24Labeling · Standard review	Approved	None posted
Sep 13, 2011	Supplement 23Labeling	Approved	None posted
Feb 19, 2009	Supplement 12Labeling	Approved	None posted
Feb 19, 2009	Supplement 11Labeling	Approved	None posted
Feb 19, 2009	Supplement 9Labeling	Approved	None posted
Jan 14, 2009	Supplement 18Labeling	Approved	None posted
Aug 29, 2008	Supplement 17Labeling	Approved	None posted
Mar 1, 2007	Supplement 6Manufacturing	Approved	None posted
Jan 27, 2007	Supplement 4Manufacturing	Approved	None posted
Jan 27, 2007	Supplement 3Manufacturing	Approved	None posted
Jul 17, 2006	Supplement 2Labeling	Approved	None posted
Jan 28, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76900
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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