Atenolol

ANDA 74099, held by Novitium Pharma. Atenolol.

As of Nov 15, 2026, ANDA 74099 (Atenolol), held by Novitium Pharma, was first approved by FDA on Apr 28, 1992, with 20 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1992
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Apr 28, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Atenolol25MG · tablet;oral	Atenolol	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Jul 29, 2025	Supplement 31Labeling · Standard review	Approved	None posted
Jul 29, 2025	Supplement 30Labeling · Standard review	Approved	None posted
Sep 14, 2005	Supplement 21Labeling	Approved	None posted
May 21, 2001	Supplement 19Manufacturing	Approved	None posted
Jun 5, 2000	Supplement 16Labeling	Approved	None posted
May 24, 1999	Supplement 15Manufacturing	Approved	None posted
Apr 5, 1999	Supplement 14Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 13Manufacturing	Approved	None posted
Jul 30, 1997	Supplement 12Manufacturing	Approved	None posted
Jul 30, 1997	Supplement 11Manufacturing	Approved	None posted
Feb 18, 1997	Supplement 10Labeling	Approved	None posted
Jun 10, 1996	Supplement 9Manufacturing	Approved	None posted
May 15, 1996	Supplement 8Manufacturing	Approved	None posted
May 15, 1996	Supplement 7Manufacturing	Approved	None posted
Oct 4, 1994	Supplement 5Manufacturing	Approved	None posted
Sep 8, 1994	Supplement 6Labeling	Approved	None posted
Jan 14, 1994	Supplement 3Manufacturing	Approved	None posted
Dec 13, 1993	Supplement 4Labeling	Approved	None posted
Feb 4, 1993	Supplement 2Labeling	Approved	None posted
Sep 25, 1992	Supplement 1Labeling	Approved	None posted
Apr 28, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 74099
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