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FDA Drug Application 103792 by GENENTECH

Application Number103792
Application Type Biologic License Application
Sponsor ApplicantGENENTECH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/25/1998N79340000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/trasgen092598L.pdf 3/15/2004
AP09/25/1998N79350000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/trasgen092598lb.pdf 3/15/2004
AP09/25/1998N79360000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080591.htm 3/15/2004
AP02/9/2000S79421005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/trasgen020900L.htm 3/15/2004
AP02/9/2000S79431005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/trasgen020900LB.htm 3/15/2004
AP012/11/2001S79405004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/trasgen121101L.htm 3/15/2004
AP012/11/2001S79415004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/trasgen121101LB.pdf 3/15/2004
AP08/28/2002S79385008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/trasgen082802L.htm 3/15/2004
AP08/28/2002S79395008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/trasgen082802LB.pdf 3/15/2004
AP010/16/2003S68925046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/103792-5046ltr.pdf 11/6/2003
AP011/16/2006S153685150   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103792s5150lbl.pdf 11/17/2006
AP011/16/2006S154335150   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103792 5150ltr.pdf 12/4/2006
AP01/18/2008S189285175   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103792s5175lbl.pdf 1/23/2008
AP01/18/2008S189365175   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5175ltr.pdf 1/23/2008
AP05/22/2008S198995187   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5187,s5189ltr.pdf 5/29/2008
AP111/20/2013N198995187   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5187,s5189ltr.pdf 5/29/2008
AP05/22/2008S326745187   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/103792s5187-5189_Herceptin_toc.cfm 5/10/2012
AP111/20/2013N326745187   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/103792s5187-5189_Herceptin_toc.cfm 5/10/2012
AP05/22/2008S382125187   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189ltr.pdf 1/2/2014
AP111/20/2013N382125187   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189ltr.pdf 1/2/2014
AP05/22/2008S327505189   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/103792s5187-5189_Herceptin_toc.cfm 5/23/2012
AP111/20/2013N327505189   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/103792s5187-5189_Herceptin_toc.cfm 5/23/2012
AP05/22/2008S382115189   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189ltr.pdf 1/2/2014
AP111/20/2013N382115189   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103792Orig1s5187,s5189ltr.pdf 1/2/2014
AP05/22/2008S198985189   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5187,s5189ltr.pdf 5/29/2008
AP111/20/2013N198985189   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103792s5187,s5189ltr.pdf 5/29/2008
AP010/20/2010S266865250   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5250lbl.pdf 10/19/2010
AP010/20/2010S267715250   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103792s5250ltr.pdf 10/26/2010
AP010/29/2010S268455256   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103792s5256lbl.pdf 11/1/2010
AP010/29/2010S271485256   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103792s5256ltr.pdf 12/3/2010
AP02/23/2012SCM445155275   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2012/103792Orig1s5275.pdf 11/18/2015
AP011/20/2013SLR378885305   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103792s5300s5305lbl.pdf 11/22/2013
AP03/7/2014SE8387255311   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103792s5311lbl.pdf 3/7/2014
AP03/7/2014SE8387315311Medical Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/103792Orig1s5311MedR.pdf 3/10/2014
AP03/7/2014SE8387445311   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5311ltr.pdf 3/11/2014
AP03/7/2014SE8388085311   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/103792Orig1s5311TOC.cfm 3/18/2014
AP06/30/2014SLR397175313   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5313,s5318ltr.pdf 7/1/2014
AP06/30/2014SLR397185318   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103792Orig1s5313,s5318ltr.pdf 7/1/2014
AP04/23/2015SLR426495327   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103792Orig1s5327ltr.pdf 4/24/2015
AP04/23/2015SLR426535327   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103792s5327lbl.pdf 4/24/2015
AP03/17/2016SLR454545330   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103792Orig1s5330ltr.pdf 3/18/2016
AP03/17/2016SLR454655330   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103792s5330lbl.pdf 3/22/2016




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