Application 125085
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AVASTIN | BEVACIZUMAB | VIAL; INTRAVENOUS | 100MG | No | No |
| 002 | AVASTIN | BEVACIZUMAB | VIAL; INTRAVENOUS | 400MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-060 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
| 50242-061 | Avastin | bevacizumab | Genentech, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74718 | SUPPL | 2023-07-11 |
| 72113 | SUPPL | 2022-09-20 |
| 72106 | SUPPL | 2022-09-19 |
| 71473 | SUPPL | 2022-06-28 |
| 69508 | SUPPL | 2021-12-07 |
| 65606 | SUPPL | 2020-12-17 |
| 65554 | SUPPL | 2020-12-09 |
| 64905 | SUPPL | 2020-10-14 |
| 64895 | SUPPL | 2020-10-14 |
| 64807 | SUPPL | 2020-10-02 |
| 64784 | SUPPL | 2020-10-01 |
| 63379 | SUPPL | 2020-06-02 |
| 63354 | SUPPL | 2020-05-29 |
| 59156 | SUPPL | 2019-06-21 |
| 59148 | SUPPL | 2019-06-21 |
| 58656 | SUPPL | 2019-05-13 |
| 54603 | SUPPL | 2018-06-14 |
| 54544 | SUPPL | 2018-06-13 |
| 53995 | SUPPL | 2018-05-03 |
| 53984 | SUPPL | 2018-05-02 |
| 50627 | SUPPL | 2017-12-07 |
| 50626 | SUPPL | 2017-12-07 |
| 46099 | SUPPL | 2016-12-08 |
| 46088 | SUPPL | 2016-12-08 |
| 18782 | SUPPL | 2015-12-02 |
| 9600 | SUPPL | 2015-12-02 |
| 39831 | SUPPL | 2015-10-07 |
| 9599 | SUPPL | 2015-10-01 |
| 31824 | SUPPL | 2015-05-11 |
| 39830 | SUPPL | 2015-05-08 |
| 9598 | SUPPL | 2014-11-17 |
| 18781 | SUPPL | 2014-11-14 |
| 39829 | SUPPL | 2014-09-03 |
| 31822 | SUPPL | 2014-09-03 |
| 44791 | SUPPL | 2014-08-19 |
| 31823 | SUPPL | 2014-08-15 |
| 18780 | SUPPL | 2014-08-14 |
| 31821 | SUPPL | 2013-12-17 |
| 18779 | SUPPL | 2013-12-17 |
| 18778 | SUPPL | 2013-04-01 |
| 31820 | SUPPL | 2013-03-28 |
| 31819 | SUPPL | 2013-01-25 |
| 39828 | SUPPL | 2013-01-24 |
| 18777 | SUPPL | 2012-11-28 |
| 9597 | SUPPL | 2012-11-23 |
| 9595 | SUPPL | 2012-10-29 |
| 39827 | SUPPL | 2012-10-26 |
| 9594 | SUPPL | 2012-05-08 |
| 18776 | SUPPL | 2012-05-07 |
| 9596 | SUPPL | 2011-12-27 |
| 9593 | SUPPL | 2011-10-04 |
| 18775 | SUPPL | 2011-09-30 |
| 22782 | SUPPL | 2011-02-15 |
| 9592 | SUPPL | 2011-02-15 |
| 31818 | SUPPL | 2011-01-10 |
| 44427 | ORIG | 2009-12-11 |
| 31816 | SUPPL | 2009-08-06 |
| 39826 | SUPPL | 2009-08-04 |
| 31817 | SUPPL | 2009-05-13 |
| 18774 | SUPPL | 2009-05-05 |
| 31815 | SUPPL | 2008-03-28 |
| 39825 | SUPPL | 2008-03-27 |
| 9591 | SUPPL | 2008-02-27 |
| 39824 | SUPPL | 2007-09-26 |
| 39823 | SUPPL | 2006-10-23 |
| 31814 | SUPPL | 2006-10-23 |
| 22781 | SUPPL | 2006-10-11 |
| 39822 | SUPPL | 2006-09-25 |
| 9590 | SUPPL | 2006-09-25 |
| 31813 | SUPPL | 2006-06-27 |
| 18773 | SUPPL | 2006-06-21 |
| 43303 | SUPPL | 2006-06-20 |
| 31812 | SUPPL | 2006-04-21 |
| 18772 | SUPPL | 2006-04-21 |
| 9589 | SUPPL | 2005-10-20 |
| 39821 | SUPPL | 2005-09-30 |
| 22780 | ORIG | 2005-01-28 |
| 31811 | ORIG | 2004-02-27 |
| 18771 | ORIG | 2004-02-27 |