Tenoretic 100, Tenoretic 50

NDA 18760, held by Twi Pharms. Atenolol; Chlorthalidone.

As of Nov 13, 2026, NDA 18760 (Tenoretic 100, Tenoretic 50), held by Twi Pharms, was first approved by FDA on Jun 8, 1984, with 29 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1984
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
Jun 8, 1984	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms


Tenoretic 100100MG;25MG · tablet;oral	Atenolol; Chlorthalidone	DiscontinuedReference drug
Tenoretic 5050MG;25MG · tablet;oral	Atenolol; Chlorthalidone	DiscontinuedReference drug

All 30 submissions, including labeling and manufacturing supplements


Dec 22, 2023	Supplement 44Labeling · Standard review	Approved	Letter Label
Oct 31, 2012	Supplement 29Labeling	Approved	Label Letter
Aug 21, 2011	Supplement 28Labeling	Approved	Label Letter
Oct 29, 2008	Supplement 27Labeling · Standard review	Approved	Label Letter
Feb 9, 2005	Supplement 26Labeling · Standard review	Approved	Letter
Oct 30, 2003	Supplement 25Labeling · Standard review	Approved	Letter
Jan 31, 2003	Supplement 24Labeling · Standard review	Approved	Letter
Apr 4, 2000	Supplement 22Labeling · Standard review	Approved	Review
Jul 21, 1999	Supplement 23Labeling · Standard review	Approved	Review
Oct 11, 1996	Supplement 21Manufacturing · Standard review	Approved	None posted
Feb 9, 1996	Supplement 20Labeling · Standard review	Approved	None posted
May 4, 1994	Supplement 18Labeling · Standard review	Approved	None posted
Jun 4, 1993	Supplement 17Labeling · Standard review	Approved	None posted
Apr 29, 1993	Supplement 16Labeling · Standard review	Approved	None posted
Aug 5, 1992	Supplement 14Labeling	Approved	None posted
Aug 5, 1992	Supplement 15Labeling	Approved	None posted
Sep 18, 1991	Supplement 13Labeling	Approved	None posted
Apr 26, 1991	Supplement 10Labeling	Approved	None posted
Apr 26, 1991	Supplement 11Labeling	Approved	None posted
Apr 26, 1991	Supplement 12Labeling	Approved	None posted
Jan 8, 1987	Supplement 9Manufacturing · Standard review	Approved	None posted
Sep 20, 1985	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 19, 1985	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 17, 1985	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 8, 1985	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 19, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 6, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 20, 1984	Supplement 2Labeling	Approved	None posted
Aug 13, 1984	Supplement 1Manufacturing · Standard review	Approved	None posted
Jun 8, 1984	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18760
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