ANDA 76257, held by Epic Pharma LLC. Glyburide.
As of Nov 14, 2026, ANDA 76257 (Glyburide), held by Epic Pharma LLC, was first approved by FDA on Jun 27, 2002, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 27, 2002 | Original application | Approved | None posted |
| Apr 13, 2015 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 13, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 30, 2010 | Supplement 8Labeling | Approved | None posted |
| Aug 19, 2010 | Supplement 5Labeling | Approved | None posted |
| Jun 23, 2010 | Supplement 6Labeling | Approved | None posted |
| Sep 18, 2009 | Supplement 4Labeling | Approved | None posted |
| Jun 27, 2002 | 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
