ANDA 73476, held by Sun Pharm Industries. Atenolol.
As of Nov 15, 2026, ANDA 73476 (Atenolol), held by Sun Pharm Industries, was first approved by FDA on Mar 30, 1993, with 18 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atenolol100MG · tablet;oral | Atenolol | Discontinued |
| Apr 29, 2015 | Supplement 35Labeling · Standard review | Approved | None posted |
| Oct 24, 2011 | Supplement 34Labeling | Approved | None posted |
| Mar 15, 2010 | Supplement 33Labeling | Approved | None posted |
| Aug 26, 2005 | Supplement 25Labeling | Approved | None posted |
| May 3, 2005 | Supplement 24Labeling | Approved | None posted |
| Jul 24, 2002 | Supplement 15Manufacturing | Approved | None posted |
| Feb 19, 2002 | Supplement 14Manufacturing | Approved | None posted |
| Sep 5, 2000 | Supplement 11Labeling | Approved | None posted |
| May 16, 2000 | Supplement 10Manufacturing | Approved | None posted |
| May 16, 2000 | Supplement 9Manufacturing | Approved | None posted |
| Dec 5, 1997 | Supplement 8Manufacturing | Approved | None posted |
| Feb 24, 1997 | Supplement 7Manufacturing | Approved | None posted |
| Nov 25, 1996 | Supplement 6Labeling | Approved | None posted |
| Jun 22, 1995 | Supplement 5Manufacturing | Approved | None posted |
| Oct 13, 1994 | Supplement 4Labeling | Approved | None posted |
| Jan 12, 1994 | Supplement 2Manufacturing | Approved | None posted |
| Dec 16, 1993 | Supplement 3Labeling | Approved | None posted |
| Apr 19, 1993 | Supplement 1Labeling | Approved | None posted |
| Mar 30, 1993 | 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
