NDA 19280, held by Pharmacia And Upjohn. Tranexamic Acid.
As of Nov 13, 2026, NDA 19280 (Cyklokapron), held by Pharmacia And Upjohn, was first approved by FDA on Dec 30, 1986, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 1986 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cyklokapron500MG · tablet;oral | Tranexamic Acid | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 1999 | Supplement 8Labeling · Standard review | Approved | |
| Dec 30, 1986 | Original applicationNew molecular entity · Standard review | 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
