Activase, Cathflo Activase
BLA 103172, held by Genentech. Alteplase.
- First approved: Nov 13, 1987
- Review: Priority
- Supplements approved: 11
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 12 submissions below| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 4, 2005 | Supplement 5071Efficacy (new indication or use) · Standard review | Approved | |
| Sep 4, 2001 | Supplement 5003Efficacy (new indication or use) · Standard review | Approved | |
| Jun 18, 1996 | Supplement 1055Efficacy (new indication or use) · Priority review | Approved | |
| Apr 3, 1995 | Supplement 1036Efficacy (new indication or use) · Priority review | Approved | None posted |
| Nov 13, 1987 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Products
3 strengths and formsAll 12 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 1, 2022 | Supplement 5268Labeling · Standard review | Approved | |
| Oct 8, 2020 | Supplement 5267Labeling · Standard review | Approved | |
| Feb 28, 2018 | Supplement 5260Labeling · Standard review | Approved | |
| Feb 28, 2018 | Supplement 5259Labeling · Standard review | Approved | |
| Jun 30, 2017 | Supplement 5253Labeling · Standard review | Approved | |
| Feb 13, 2015 | Supplement 5203Labeling · Standard review | Approved | |
| Jan 4, 2005 | Supplement 5071Efficacy (new indication or use) · Standard review | Approved | |
| May 15, 2002 | Supplement 5009 | Approved | |
| Sep 4, 2001 | Supplement 5003Efficacy (new indication or use) · Standard review | Approved | |
| Jun 18, 1996 | Supplement 1055Efficacy (new indication or use) · Priority review | Approved | |
| Apr 3, 1995 | Supplement 1036Efficacy (new indication or use) · Priority review | Approved | None posted |
| Nov 13, 1987 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Identifiers
- Application
- BLA 103172
- Drugs@FDA
- Overview at FDA
- Company
- Genentech
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters