BLA 20304, held by Bayer Hlthcare. Aprotinin.
As of Nov 14, 2026, BLA 20304 (Trasylol), held by Bayer Hlthcare, was first approved by FDA on Dec 29, 1993, with 12 approved supplements and 0 published complete response letters.
| Aug 28, 1998 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 12, 1994 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | None posted |
| Dec 29, 1993 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trasylol10,000KIU/ML · injectable;injection | Aprotinin | Discontinued |
| Dec 15, 2006 | Supplement 22Labeling · Standard review | Approved | |
| Sep 18, 2001 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Apr 11, 2001 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Jul 24, 2000 | Supplement 9Labeling · Standard review | Approved | |
| Sep 21, 1999 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 5, 1999 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 28, 1998 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Sep 30, 1997 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 8, 1997 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 19, 1995 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 12, 1994 | Supplement 2Efficacy (new indication or use) · Priority review | Approved | None posted |
| Feb 7, 1994 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Dec 29, 1993 | Original applicationNew molecular entity · Priority review | 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
