Back to FDA Applications sponsored by ASTELLAS

FDA Drug Application 125036 by ASTELLAS

Application Number125036
Application Type Biologic License Application
Sponsor ApplicantASTELLAS
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
AP01/30/2003N78810000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080439.htm 3/11/2004
AP01/30/2003N78820000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/alefbio013003L.htm 3/11/2004
AP01/30/2003N78830000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/alefbio013003LB.htm 3/11/2004
AP05/3/2011S287410135   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125036s0135ltr.pdf 5/6/2011
AP05/3/2011S287470135   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125036s0135lbl.pdf 5/6/2011
AP012/28/2011S313450142   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125036s0142ltr.pdf 1/5/2012
AP012/28/2011S313570142   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125036s0142lbl.pdf 1/6/2012
AP05/1/2012S326000144   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125036s0144lbl.pdf 5/2/2012
AP05/1/2012S326010144   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125036s0144mg.pdf 5/2/2012
AP05/1/2012S326080144   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125036s0144ltr.pdf 5/3/2012
AP09/1/2005S18301044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125036s044lbl.pdf 10/31/2007
AP010/18/2006S18302071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125036s071lbl.pdf 10/31/2007
AP010/18/2006S18303073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125036s073lbl.pdf 10/31/2007
AP03/1/2009S22061100   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125036s100lbl.pdf 3/19/2009
AP03/1/2009S22076100   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125036s100ltr.pdf 3/23/2009
AP02/28/2011S28354131   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125036s131ltr.pdf 3/25/2011




Back to FDA Applications sponsored by ASTELLAS