Back to FDA Applications sponsored by AMGEN

FDA Drug Application 125031 by AMGEN

Application Number125031
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
AP01/31/2002N80400000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/pegfamg013102L.htm 3/25/2004
AP01/31/2002N80410000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegfamg013102LB.pdf 3/25/2004
AP01/31/2002N80420000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/pegfamg013102ptLB.pdf 3/25/2004
AP01/31/2002N104540000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125031_0000_NeulastaTOC.cfm 10/25/2004
AP012/17/2004S110120048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125031_0048ltr.pdf 1/26/2005
AP012/17/2004S110430048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125031_0048lbl.pdf 1/26/2005
AP01/24/2005S110520051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125031_0051lbl.pdf 1/26/2005
AP01/24/2005S110340051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125031_0051ltr.pdf 1/26/2005
AP09/16/2005S135980052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125031s0052lbl.pdf 2/8/2006
AP010/25/2006S153350072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125031s072LTR.pdf 11/9/2006
AP010/25/2006S153360072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125031s072LBL.pdf 11/9/2006
AP07/23/2007S174410082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125031s082ltr.pdf 8/1/2007
AP07/23/2007S174580082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125031s082lbl.pdf 8/2/2007
AP04/16/2008S198740095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s0095ltr.pdf 5/22/2008
AP05/25/2012S327690142   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125031s0142ltr.pdf 5/29/2012
AP05/25/2012S327750142   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125031s0142lbl.pdf 5/29/2012
AP011/14/2008S21322091   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s091s105ltr.pdf 12/4/2008
AP011/14/2008S21323105   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125031s091s105ltr.pdf 12/4/2008
AP02/17/2010S25150120   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125031s120ltr.pdf 3/31/2010
AP06/3/2011S29152130   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125031s130ltr.pdf 6/15/2011
AP09/23/2015SLR43987170   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf 9/24/2015
AP09/23/2015SLR44140170   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf 10/6/2015
AP012/23/2014SCM41453175   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125031Orig1s175ltr.pdf 12/30/2014
AP09/23/2015SLR43988179   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf 9/24/2015
AP09/23/2015SLR44141179   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf 10/6/2015
AP011/13/2015SLR44535180   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s180lbl.pdf 11/19/2015
AP011/13/2015SLR44868180   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s180ltr.pdf 12/23/2015
AP09/23/2015SLR44142181   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125031s170s179s181lbl.pdf 10/6/2015
AP09/23/2015SLR43989181   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125031Orig1s170,s179,s181ltr.pdf 9/24/2015
AP04/28/2016SLR45810184   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125031s184lbl.pdf 4/29/2016
AP04/28/2016SLR45851184   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125031Orig1s184ltr.pdf 5/3/2016




Back to FDA Applications sponsored by AMGEN