Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103792
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://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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103792s5175lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5175ltr.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
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

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