Atenolol

ANDA 73542, held by Novitium Pharma. Atenolol.

As of Nov 15, 2026, ANDA 73542 (Atenolol), held by Novitium Pharma, was first approved by FDA on Dec 19, 1991, with 19 approved supplements and 0 published complete response letters.

First approved: Dec 19, 1991
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Dec 19, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Atenolol50MG · tablet;oral	Atenolol	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Jul 29, 2025	Supplement 30Labeling · Standard review	Approved	None posted
Jul 29, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Sep 19, 2005	Supplement 20Labeling	Approved	None posted
May 21, 2001	Supplement 18Manufacturing	Approved	None posted
Jun 5, 2000	Supplement 15Labeling	Approved	None posted
May 24, 1999	Supplement 14Manufacturing	Approved	None posted
Apr 5, 1999	Supplement 13Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 12Manufacturing	Approved	None posted
Feb 18, 1997	Supplement 11Labeling	Approved	None posted
May 15, 1996	Supplement 10Manufacturing	Approved	None posted
May 15, 1996	Supplement 9Manufacturing	Approved	None posted
Oct 4, 1994	Supplement 7Manufacturing	Approved	None posted
Sep 8, 1994	Supplement 8Labeling	Approved	None posted
May 17, 1994	Supplement 4Manufacturing	Approved	None posted
Jan 14, 1994	Supplement 6Manufacturing	Approved	None posted
Dec 13, 1993	Supplement 5Labeling	Approved	None posted
Feb 4, 1993	Supplement 3Labeling	Approved	None posted
Sep 25, 1992	Supplement 2Labeling	Approved	None posted
Apr 22, 1992	Supplement 1Labeling	Approved	None posted
Dec 19, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 73542
Drugs@FDA: Overview at FDA
Company: Novitium Pharma

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