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FDA Drug Application 125276 by GENENTECH

Application Number125276
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
AP01/8/2010N244890000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125276lbl.pdf 1/12/2010
AP01/8/2010N245070000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM197463.pdf 1/13/2010
AP01/8/2010N246350000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125276s000ltr.pdf 1/26/2010
AP01/8/2010N250060000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000TOC.cfm 3/9/2010
AP01/8/2010N250070000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125276s000SumR.pdf 3/9/2010
AP04/15/2011S285670022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf 4/18/2011
AP04/15/2011S289580022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s0022,s0023ltr.pdf 5/26/2011
AP04/15/2011S289590023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s0022,s0023ltr.pdf 5/26/2011
AP04/15/2011S285680023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s0022s0023lbl.pdf 4/18/2011
AP08/13/2012S334460046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276Orig1s0046ltr.pdf 8/15/2012
AP08/13/2012S334610046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0046lbl.pdf 8/15/2012
AP06/20/2012S329610048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276s0048ltr.pdf 6/22/2012
AP010/11/2012SE5340940049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125276Orig1s0049ltr.pdf 10/15/2012
AP010/11/2012SE5341070049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125276s0049lbl.pdf 10/15/2012
AP010/11/2012SE5348000049   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2012/125276Orig1s049TOC.cfm 12/28/2012
AP01/4/2011S27512007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf 1/11/2011
AP01/4/2011S27513010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf 1/11/2011
AP01/4/2011S27486010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s007,s010,s011ltr.pdf 1/7/2011
AP01/4/2011S27487011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125276s007,s010,s011ltr.pdf 1/7/2011
AP01/4/2011S27514011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125276s007s010s011lbl.pdf 1/11/2011
AP04/29/2013SE835897064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s064ltr.pdf 5/1/2013
AP04/29/2013SE835920064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s064lbl.pdf 5/1/2013
AP07/2/2013SLR36447075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s075ltr.pdf 7/5/2013
AP010/21/2013SLR37498092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125276s092lbl.pdf 10/21/2013
AP010/21/2013SLR37500092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125276Orig1s092ltr.pdf 10/22/2013
AP011/13/2014SLR40993105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125276Orig1s105ltr.pdf 11/14/2014
AP08/18/2015SE843696106   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125276s106,125472s014ltr.pdf 8/21/2015
AP09/23/2016SE847170107   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125276Orig1s107,125472Orig1s018ltr.pdf 9/26/2016
AP09/23/2016SE847176107   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125276s107_125472s018lbl.pdf 9/27/2016




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