Application 103792
- Type
- BLA
- Sponsor
- GENENTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HERCEPTIN | TRASTUZUMAB | VIAL; INTRAVENOUS | 21MG/ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50242-132 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-132 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-132 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-132 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-132 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-132 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-134 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-134 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-134 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-134 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-134 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-333 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-333 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-333 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
| 50242-333 | Herceptin | Trastuzumab | Genentech, Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85985 | SUPPL | 2026-05-19 |
| 85968 | SUPPL | 2026-05-19 |
| 78853 | SUPPL | 2024-06-20 |
| 78830 | SUPPL | 2024-06-20 |
| 64228 | SUPPL | 2020-08-06 |
| 56058 | SUPPL | 2018-12-20 |
| 56600 | SUPPL | 2018-11-30 |
| 56008 | SUPPL | 2018-10-18 |
| 56002 | SUPPL | 2018-10-17 |
| 55730 | SUPPL | 2018-10-01 |
| 48857 | SUPPL | 2017-06-28 |
| 48198 | SUPPL | 2017-05-02 |
| 48168 | SUPPL | 2017-04-28 |
| 18656 | SUPPL | 2016-03-22 |
| 9466 | SUPPL | 2016-03-18 |
| 22751 | SUPPL | 2015-11-18 |
| 39718 | SUPPL | 2015-04-24 |
| 9465 | SUPPL | 2015-04-24 |
| 31673 | SUPPL | 2014-07-01 |
| 9464 | SUPPL | 2014-07-01 |
| 22752 | SUPPL | 2014-03-18 |
| 9463 | SUPPL | 2014-03-11 |
| 44559 | SUPPL | 2014-03-10 |
| 39717 | SUPPL | 2014-03-07 |
| 9462 | SUPPL | 2014-01-02 |
| 9461 | SUPPL | 2014-01-02 |
| 18655 | SUPPL | 2013-11-22 |
| 43286 | SUPPL | 2012-05-23 |
| 43285 | SUPPL | 2012-05-10 |
| 31672 | SUPPL | 2010-12-03 |
| 18654 | SUPPL | 2010-11-01 |
| 31671 | SUPPL | 2010-10-26 |
| 39716 | SUPPL | 2010-10-19 |
| 31670 | SUPPL | 2008-05-29 |
| 31669 | SUPPL | 2008-05-29 |
| 39715 | SUPPL | 2008-01-23 |
| 9460 | SUPPL | 2008-01-23 |
| 60818 | SUPPL | 2008-01-18 |
| 31668 | SUPPL | 2006-12-04 |
| 18653 | SUPPL | 2006-11-17 |
| 39714 | SUPPL | 2004-03-15 |
| 39713 | SUPPL | 2004-03-15 |
| 39712 | SUPPL | 2004-03-15 |
| 39711 | ORIG | 2004-03-15 |
| 31666 | SUPPL | 2004-03-15 |
| 31665 | SUPPL | 2004-03-15 |
| 31664 | ORIG | 2004-03-15 |
| 22750 | ORIG | 2004-03-15 |
| 9459 | SUPPL | 2004-03-15 |
| 31667 | SUPPL | 2003-11-06 |