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FDA Drug Application 103353 by AMGEN

Application Number103353
Application Type Biologic License Application
Sponsor ApplicantAMGEN
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
AP02/20/1991N308470000   http://www.accessdata.fda.gov/drugsatfda_docs/bla/pre96/103353Orig1s000.pdf 12/2/2011
AP04/2/1998S80521036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/filgamg040298L.htm 3/25/2004
AP04/2/1998S80531036   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/filgamg040298lb.pdf 3/25/2004
AP04/2/1998S80541036   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080686.htm 3/25/2004
AP05/29/2002S102605001Physician Package Insert Part 1  http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902PLBp1.pdf 9/22/2004
AP05/29/2002S102615001Physician Package Insert Part 2  http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902PLBp2.pdf 9/22/2004
AP05/29/2002S102625001Physician Package Insert 3  http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902PLBp3.pdf 9/22/2004
AP05/29/2002S80505001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/filgamg052902L.pdf 3/25/2004
AP05/29/2002S80515001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/filgamg052902LB.pdf 3/25/2004
AP012/17/2004S110165059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103353_5059ltr.pdf 1/26/2005
AP012/17/2004S110405059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103353_5059lbl.pdf 1/26/2005
AP010/25/2006S153345086   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103353s5086LTR.pdf 11/9/2006
AP010/25/2006S153375086   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103353s5086LBL.pdf 11/9/2006
AP03/2/2010S250015127   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103353s5127ltr.pdf 3/8/2010
AP03/2/2010S250305127   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103353_5127lbl.pdf 3/11/2010
AP05/25/2012S327705147   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103353s5147ltr.pdf 5/29/2012
AP05/25/2012S327765147   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103353s5147lbl.pdf 5/29/2012
AP09/13/2013SLR371095157   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103353s5157lbl.pdf 9/17/2013
AP09/13/2013SLR371415157   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103353Orig1s5157ltr.pdf 9/17/2013
AP03/30/2015SE8424075183   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5183ltr.pdf 4/3/2015
AP02/6/2015SLR418005184   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5184lbl.pdf 2/6/2015
AP02/6/2015SLR418015184   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5184ltr.pdf 2/6/2015
AP07/30/2015SLR435505186   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103353Orig1s5186ltr.pdf 7/31/2015
AP07/30/2015SLR435615186   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103353s5186lbl.pdf 8/4/2015
AP06/29/2016S464455188   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103353Orig1s5188ltr.pdf 6/30/2016
AP06/29/2016S465985188   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103353s5188.pdf 7/22/2016




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