ANDA 73353, held by Watson Labs Teva. Atenolol.
As of Nov 15, 2026, ANDA 73353 (Atenolol), held by Watson Labs Teva, was first approved by FDA on Dec 27, 1991, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 1991 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atenolol100MG ยท tablet;oral | Atenolol | Discontinued |
| Dec 13, 2006 | Supplement 26Labeling | Approved | None posted |
| Jun 22, 2006 | Supplement 25Labeling | Approved | None posted |
| Sep 25, 2003 | Supplement 22Labeling | Approved | None posted |
| Apr 25, 2001 | Supplement 18Manufacturing | Approved | None posted |
| Mar 30, 2001 | Supplement 19Labeling | Approved | None posted |
| Aug 7, 2000 | Supplement 17Labeling | Approved | None posted |
| Dec 15, 1997 | Supplement 14Manufacturing | Approved | None posted |
| Dec 15, 1997 | Supplement 13Manufacturing | Approved | None posted |
| Jun 23, 1997 | Supplement 12Manufacturing | Approved | None posted |
| Nov 25, 1996 | Supplement 11Labeling | Approved | None posted |
| Nov 8, 1994 | Supplement 10Labeling | Approved | None posted |
| Mar 31, 1994 | Supplement 9Labeling | Approved | None posted |
| Jul 22, 1993 | Supplement 7Manufacturing | Approved | None posted |
| May 5, 1993 | Supplement 6Labeling | Approved | None posted |
| Dec 7, 1992 | Supplement 3Labeling | Approved | None posted |
| Jul 22, 1992 | Supplement 1Manufacturing | Approved | None posted |
| Jul 6, 1992 | Supplement 2Labeling | Approved | None posted |
| Dec 27, 1991 | Original application | Approved | None posted |
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
