Atenolol

ANDA 72304, held by Aiping Pharm Inc. Atenolol.

As of Nov 15, 2026, ANDA 72304 (Atenolol), held by Aiping Pharm Inc, was first approved by FDA on Jul 15, 1988, with 22 approved supplements and 0 published complete response letters.

First approved: Jul 15, 1988
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jul 15, 1988	Original application	Approved	None posted

Products

3 strengths and forms


Atenolol100MG · tablet;oral	Atenolol	Rx
Atenolol25MG · tablet;oral	Atenolol	Rx
Atenolol50MG · tablet;oral	Atenolol	Rx

All 23 submissions, including labeling and manufacturing supplements


Jun 7, 2002	Supplement 25Manufacturing	Approved	None posted
Dec 26, 2000	Supplement 24Manufacturing	Approved	None posted
Aug 2, 1999	Supplement 23Manufacturing	Approved	None posted
Oct 9, 1997	Supplement 21Manufacturing	Approved	None posted
Jan 29, 1997	Supplement 22Labeling	Approved	None posted
May 25, 1995	Supplement 20Manufacturing	Approved	None posted
Oct 18, 1994	Supplement 19Labeling	Approved	None posted
Dec 16, 1993	Supplement 18Labeling	Approved	None posted
Mar 10, 1993	Supplement 17Labeling	Approved	None posted
Jun 18, 1992	Supplement 16Labeling	Approved	None posted
Jun 18, 1992	Supplement 15Manufacturing	Approved	None posted
Jun 18, 1992	Supplement 14Manufacturing	Approved	None posted
Dec 6, 1991	Supplement 13Labeling	Approved	None posted
Nov 8, 1990	Supplement 12Labeling	Approved	None posted
Oct 1, 1990	Supplement 11Labeling	Approved	None posted
Dec 15, 1989	Supplement 10Labeling	Approved	None posted
Aug 14, 1989	Supplement 5Manufacturing	Approved	None posted
Aug 14, 1989	Supplement 4Labeling	Approved	None posted
Aug 14, 1989	Supplement 3Manufacturing	Approved	None posted
Aug 14, 1989	Supplement 2Manufacturing	Approved	None posted
Mar 29, 1989	Supplement 1Manufacturing	Approved	None posted
Dec 15, 1988	Supplement 6Manufacturing	Approved	None posted
Jul 15, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 72304
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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