ANDA 75602, held by Hikma. Aminocaproic Acid.
As of Nov 15, 2026, ANDA 75602 (Aminocaproic), held by Hikma, was first approved by FDA on May 24, 2001, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aminocaproic500MG ยท tablet;oral | Aminocaproic Acid | Discontinued |
| Aug 31, 2010 | Supplement 10Labeling | Approved | None posted |
| Aug 31, 2010 | Supplement 9Labeling | Approved | None posted |
| Aug 26, 2004 | Supplement 4Labeling | Approved | None posted |
| Aug 13, 2002 | Supplement 1Manufacturing | Approved | None posted |
| May 24, 2001 | 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
