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FDA Drug Application 103976 by GENENTECH

Application Number103976
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
AP06/20/2003N81700000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093373.htm 3/30/2004
AP06/20/2003N81710000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/omalgen062003L.htm 3/30/2004
AP06/20/2003N81720000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf 3/30/2004
AP06/20/2003N81730000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103291.htm 3/30/2004
AP04/7/2006S139365087   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103976s5097ltr.pdf 4/14/2006
AP04/7/2006S139375087   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103976s5097lbl.pdf 4/14/2006
AP07/2/2007S168665102   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf 7/2/2007
AP07/2/2007S168675102   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089829.pdf 7/2/2007
AP09/26/2014SE8406615161   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5161lbl.pdf 9/30/2014
AP09/26/2014SE8406775161   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5161ltr.pdf 10/1/2014
AP01/1/2010S247245166   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103976s5166ltr.pdf 2/5/2010
AP012/21/2010S274935180   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103976s5180ltr.pdf 1/10/2011
AP012/22/2011S313435191   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103976s5191ltr.pdf 1/5/2012
AP03/21/2014SE8388825211   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5211ltr.pdf 3/25/2014
AP03/21/2014SE8388945211   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5211lbl.pdf 3/25/2014
AP012/3/2015SLR446815224   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103976Orig1s5224ltr.pdf 12/8/2015
AP012/3/2015SLR446945224   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103976s5224lbl.pdf 12/8/2015
AP07/6/2016SE8464735225   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103976Orig1s5225ltr.pdf 7/7/2016
AP07/6/2016SE8464805225   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf 7/8/2016




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