Atenolol

ANDA 74499, held by Sun Pharm Industries. Atenolol.

As of Nov 15, 2026, ANDA 74499 (Atenolol), held by Sun Pharm Industries, was first approved by FDA on Jul 30, 1997, with 13 approved supplements and 0 published complete response letters.

First approved: Jul 30, 1997
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Jul 30, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Atenolol25MG · tablet;oral	Atenolol	Discontinued

All 14 submissions, including labeling and manufacturing supplements


Apr 29, 2015	Supplement 34Labeling · Standard review	Approved	None posted
Oct 24, 2011	Supplement 33Labeling	Approved	None posted
Mar 15, 2010	Supplement 32Labeling	Approved	None posted
Aug 26, 2005	Supplement 22Labeling	Approved	None posted
May 3, 2005	Supplement 21Labeling	Approved	None posted
Jul 24, 2002	Supplement 12Manufacturing	Approved	None posted
Feb 19, 2002	Supplement 10Manufacturing	Approved	None posted
Dec 28, 2001	Supplement 9Manufacturing	Approved	None posted
Dec 28, 2001	Supplement 11Manufacturing	Approved	None posted
Sep 5, 2000	Supplement 4Labeling	Approved	None posted
May 16, 2000	Supplement 2Manufacturing	Approved	None posted
May 16, 2000	Supplement 3Manufacturing	Approved	None posted
Mar 25, 1998	Supplement 1Manufacturing	Approved	None posted
Jul 30, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74499
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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