Tenormin

Treats hypertension. NDA 18240, held by Twi Pharms. Atenolol.

As of Nov 13, 2026, NDA 18240 (Tenormin), held by Twi Pharms, was first approved by FDA on Aug 19, 1981, with 36 approved supplements and 0 published complete response letters.

First approved: Aug 19, 1981
Review: Standard
Supplements approved: 36
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hypertension TENORMIN 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 37 submissions below


Apr 9, 1990	Supplement 13Efficacy (new indication or use)	Approved	None posted
Sep 13, 1989	Supplement 5Efficacy (new indication or use)	Approved	None posted
Sep 4, 1985	Supplement 2Efficacy (new indication or use)	Approved	None posted
Aug 19, 1981	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

3 strengths and forms


Tenormin50MG · tablet;oral	Atenolol	RxReference drug
Tenormin100MG · tablet;oral	Atenolol	RxReference drug
Tenormin25MG · tablet;oral	Atenolol	RxReference drug

All 37 submissions, including labeling and manufacturing supplements


Dec 22, 2023	Supplement 47Labeling · Standard review	Approved	Letter Label
Sep 10, 2015	Supplement 39Manufacturing · Standard review	Approved	None posted
Sep 3, 2015	Supplement 38Manufacturing · Standard review	Approved	None posted
Aug 27, 2015	Supplement 37Manufacturing · Standard review	Approved	None posted
Jul 16, 2015	Supplement 35Manufacturing · Standard review	Approved	None posted
Jul 15, 2015	Supplement 34Manufacturing · Standard review	Approved	None posted
Jul 9, 2015	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 31, 2012	Supplement 32Labeling	Approved	Label Letter
Aug 17, 2011	Supplement 31Labeling · Standard review	Approved	Label Letter
Apr 29, 2008	Supplement 30Labeling · Standard review	Approved	Letter
Feb 9, 2005	Supplement 29Labeling · Standard review	Approved	Letter
Nov 6, 2003	Supplement 28Labeling · Standard review	Approved	Letter
Jan 9, 2003	Supplement 27Labeling · Standard review	Approved	Letter
Apr 4, 2000	Supplement 25Labeling · Standard review	Approved	Review
Jul 21, 1999	Supplement 26Labeling · Standard review	Approved	Review
Oct 11, 1996	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 9, 1996	Supplement 23Labeling · Standard review	Approved	None posted
May 4, 1994	Supplement 21Labeling · Standard review	Approved	None posted
Apr 29, 1993	Supplement 20Labeling · Standard review	Approved	None posted
Aug 5, 1992	Supplement 19Labeling	Approved	None posted
Aug 5, 1992	Supplement 18Labeling	Approved	None posted
Sep 18, 1991	Supplement 17Labeling	Approved	None posted
Feb 21, 1991	Supplement 16Labeling	Approved	None posted
Feb 21, 1991	Supplement 15Labeling	Approved	None posted
Feb 21, 1991	Supplement 14Labeling	Approved	None posted
Apr 9, 1990	Supplement 13Efficacy (new indication or use)	Approved	None posted
Sep 13, 1989	Supplement 5Efficacy (new indication or use)	Approved	None posted
Feb 13, 1987	Supplement 11Manufacturing · Standard review	Approved	None posted
Sep 18, 1985	Supplement 9Labeling	Approved	None posted
Sep 4, 1985	Supplement 2Efficacy (new indication or use)	Approved	None posted
Nov 19, 1984	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 12, 1984	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 15, 1983	Supplement 6Manufacturing · Standard review	Approved	None posted
Sep 27, 1983	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 7, 1983	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 23, 1981	Supplement 1Labeling	Approved	None posted
Aug 19, 1981	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18240
Drugs@FDA: Overview at FDA
Company: TWi Pharmaceuticals

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