ANDA 74759, held by Epic Pharma LLC. Aminocaproic Acid.
As of Nov 15, 2026, ANDA 74759 (Aminocaproic Acid), held by Epic Pharma LLC, was first approved by FDA on Sep 2, 1998, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 2, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminocaproic Acid0.25GM/ML ยท solution;oral | Aminocaproic Acid | Discontinued |
| Aug 31, 2010 | Supplement 11Labeling | Approved | None posted |
| Aug 31, 2010 | Supplement 10Labeling | Approved | None posted |
| Aug 13, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Apr 23, 2002 | Supplement 2Manufacturing | Approved | None posted |
| Apr 23, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Sep 2, 1998 | Original application | Approved |
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
