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FDA Drug Application 103172 by GENENTECH

Application Number103172
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
AP06/18/1996N78410000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080430.htm 3/10/2004
AP06/18/1996N78420000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1996/altegen061896L.htm 3/10/2004
AP09/4/2001S79205003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/altegen090401L.htm 3/12/2004
AP09/4/2001S79215003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/altegen090401LB.pdf 3/12/2004
AP05/15/2002S78435009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/altegen051502L.htm 3/10/2004
AP05/15/2002S78445009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/altegen051502LB.pdf 3/10/2004
AP01/4/2005S122935071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103172s5071lbl.pdf 7/27/2005
AP02/13/2015S418575203   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103172Orig1s5203ltr.pdf 2/17/2015
AP02/13/2015S419555203   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103172s5203lbl.pdf 3/2/2015
AP02/13/2015S437125203   http://www.accessdata.fda.gov/drugsatfda_docs/bla/2015/103172Orig1s5203.pdf 8/25/2015




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