ANDA 74265, held by Chartwell Rx. Atenolol.
As of Nov 15, 2026, ANDA 74265 (Atenolol), held by Chartwell Rx, was first approved by FDA on Feb 28, 1994, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 1994 | Original application | Approved | None posted |
| Jan 27, 2000 | Supplement 12Manufacturing | Approved | None posted |
| Jan 27, 2000 | Supplement 13Manufacturing | Approved | None posted |
| Jan 27, 2000 | Supplement 14Manufacturing | Approved | None posted |
| Jan 27, 2000 | Supplement 15Manufacturing | Approved | None posted |
| Oct 21, 1997 | Supplement 10Manufacturing | Approved | None posted |
| Aug 8, 1997 | Supplement 11Labeling | Approved | None posted |
| Jun 4, 1997 | Supplement 8Manufacturing | Approved | None posted |
| Apr 1, 1997 | Supplement 9Labeling | Approved | None posted |
| Mar 13, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Mar 13, 1996 | Supplement 4Manufacturing | Approved | None posted |
| Mar 13, 1996 | Supplement 5Labeling | Approved | None posted |
| Mar 13, 1996 | Supplement 6Manufacturing | Approved | None posted |
| Mar 13, 1996 | Supplement 7Manufacturing | Approved | None posted |
| Sep 2, 1994 | Supplement 2Labeling | Approved | None posted |
| Aug 1, 1994 | Supplement 1Labeling | Approved | None posted |
| Feb 28, 1994 | 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
