Atenolol

ANDA 74120, held by Teva Pharms. Atenolol.

As of Nov 15, 2026, ANDA 74120 (Atenolol), held by Teva Pharms, was first approved by FDA on Feb 24, 1995, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 24, 1995
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 24, 1995	Original application	Approved	None posted

Products

2 strengths and forms


Atenolol50MG · tablet;oral	Atenolol	Discontinued
Atenolol100MG · tablet;oral	Atenolol	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Mar 23, 1999	Supplement 3Manufacturing	Approved	None posted
Nov 25, 1996	Supplement 2Labeling	Approved	None posted
May 31, 1996	Supplement 1Manufacturing	Approved	None posted
Feb 24, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74120
Drugs@FDA: Overview at FDA
Company: Teva 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