ANDA 78254, held by Northstar Hlthcare. Atenolol.
As of Nov 15, 2026, ANDA 78254 (Atenolol), held by Northstar Hlthcare, was first approved by FDA on Sep 25, 2009, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 25, 2009 | Original application | Approved | None posted |
| Dec 11, 2014 | Supplement 2Labeling | Approved | None posted |
| Dec 11, 2014 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 11, 2014 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 25, 2009 | 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
