Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103792
Company: GENENTECH
Company: GENENTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HERCEPTIN | TRASTUZUMAB | 21MG/ML | VIAL; INTRAVENOUS | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/25/1998 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/trasgen092598lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf https://web.archive.org/web/20170128163102/https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080591.htm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/18/2024 | SUPPL-5354 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103792s5354lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103792Orig1s5354;761106Orig1s010ltr.pdf | |
| 08/05/2020 | SUPPL-5349 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103792Orig1s5349ltr.pdf |
| 10/17/2018 | SUPPL-5347 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5347lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103792Orig1s5345ltr.pdf | |
| 11/29/2018 | SUPPL-5345 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf | |
| 09/20/2018 | SUPPL-5344 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5344lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf | |
| 03/27/2017 | SUPPL-5339 | Supplement |
Label is not available on this site. |
||
| 04/27/2017 | SUPPL-5337 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103792s5337lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/103792Orig1s5337ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/103792Orig1s5337.pdf | |
| 03/17/2016 | SUPPL-5330 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103792s5330lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103792Orig1s5330ltr.pdf | |
| 04/23/2015 | SUPPL-5327 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103792s5327lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103792Orig1s5327ltr.pdf | |
| 06/30/2014 | SUPPL-5318 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5313,s5318ltr.pdf |
| 06/30/2014 | SUPPL-5313 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5313,s5318ltr.pdf |
| 03/07/2014 | SUPPL-5311 | Supplement |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103792s5311lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5311ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/103792Orig1s5311TOC.cfm | |
| 11/20/2013 | SUPPL-5305 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103792s5300s5305lbl.pdf | |
| 02/23/2012 | SUPPL-5275 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/bla/2012/103792Orig1s5275.pdf |
| 10/29/2010 | SUPPL-5256 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5256lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103792s5256ltr.pdf | |
| 10/20/2010 | SUPPL-5250 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103792s5250ltr.pdf | |
| 04/08/2009 | SUPPL-5213 | Supplement |
Label is not available on this site. |
||
| 05/22/2008 | SUPPL-5189 | Supplement |
Letter (PDF)
Letter (PDF) Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5187,s5189ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/103792s5187-5189_Herceptin_toc.cfm |
| 05/22/2008 | SUPPL-5187 | Supplement |
Letter (PDF)
Letter (PDF) Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5187,s5189ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/103792s5187-5189_Herceptin_toc.cfm |
| 01/18/2008 | SUPPL-5175 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103792s5175lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5175ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/103792Orig1s5175.pdf | |
| 11/16/2006 | SUPPL-5150 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103792s5150lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103792 5150ltr.pdf | |
| 10/16/2003 | SUPPL-5046 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103792-5046ltr.pdf |
| 08/28/2002 | SUPPL-5008 | Supplement |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/trasgen082802LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/trasgen082802L.htm | |
| 12/11/2001 | SUPPL-5004 | Supplement |
Label (PDF)
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/trasgen121101LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/trasgen121101L.htm | |
| 02/09/2000 | SUPPL-1005 | Supplement |
Label
Letter |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/trasgen020900LB.htm https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/trasgen020900L.htm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/18/2024 | SUPPL-5354 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103792s5354lbl.pdf | |
| 11/29/2018 | SUPPL-5345 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5345lbl.pdf | |
| 10/17/2018 | SUPPL-5347 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5347lbl.pdf | |
| 09/20/2018 | SUPPL-5344 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103792s5344lbl.pdf | |
| 04/27/2017 | SUPPL-5337 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103792s5337lbl.pdf | |
| 04/27/2017 | SUPPL-5337 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103792s5337lbl.pdf | |
| 03/17/2016 | SUPPL-5330 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103792s5330lbl.pdf | |
| 04/23/2015 | SUPPL-5327 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103792s5327lbl.pdf | |
| 03/07/2014 | SUPPL-5311 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103792s5311lbl.pdf | |
| 11/20/2013 | SUPPL-5305 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103792s5300s5305lbl.pdf | |
| 10/29/2010 | SUPPL-5256 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5256lbl.pdf | |
| 10/20/2010 | SUPPL-5250 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf | |
| 01/18/2008 | SUPPL-5175 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103792s5175lbl.pdf | |
| 11/16/2006 | SUPPL-5150 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103792s5150lbl.pdf | |
| 08/28/2002 | SUPPL-5008 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/trasgen082802LB.pdf | |
| 12/11/2001 | SUPPL-5004 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/trasgen121101LB.pdf | |
| 02/09/2000 | SUPPL-1005 | Supplement | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/trasgen020900LB.htm | ||
| 09/25/1998 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/trasgen092598lb.pdf |