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FDA Drug Application 103780 by SERONO INC

Application Number103780
Application Type Biologic License Application
Sponsor ApplicantSERONO INC
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
AP03/7/2002N72730000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ifnbser030702L.htm 12/17/2003
AP03/7/2002N72740000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ifnbser030702LB.pdf 12/17/2003
AP03/7/2002N72750000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089019.pdf 12/17/2003
AP03/7/2002N72760000   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080737.htm 12/17/2003
AP05/2/2003S80775010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/ifnbser050203L.htm 3/26/2004
AP05/2/2003S80785010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/ifnbser050203LB.pdf 3/26/2004
AP05/2/2003S80795010   http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm080739.htm 3/26/2004
AP012/23/2004S110185030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5030ltr.pdf 1/26/2005
AP012/23/2004S110395030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5030lbl.pdf 1/26/2005
AP012/17/2004S110135052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103780_5052ltr.pdf 1/26/2005
AP012/17/2004S110375052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103780_5052lbl.pdf 1/26/2005
AP06/30/2005S120355062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/103780s5062ltr.pdf 7/21/2005
AP06/30/2005S120385062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/103780s5062lbl.pdf 7/21/2005
AP012/21/2012SCM347865121   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103780Orig1s5121ltr.pdf 12/28/2012
AP012/21/2012SCM347975121   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103780s5121lbl.pdf 12/28/2012
AP04/19/2013SLR357865140   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103780s5140lbl.pdf 4/23/2013
AP04/19/2013SLR358345140   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103780Orig1s5140ltr.pdf 4/24/2013
AP03/10/2015SLR421045172   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5172ltr.pdf 3/11/2015
AP03/10/2015SLR421265172   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5172lbl.pdf 3/12/2015
AP04/24/2014SLR391475178   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179ltr.pdf 4/25/2014
AP04/24/2014SLR391565178   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf 4/28/2014
AP04/24/2014SLR391485179   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103780Orig1s5178,s5179ltr.pdf 4/25/2014
AP04/24/2014SLR391575179   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103780s5178s5179lbl.pdf 4/28/2014
AP012/22/2015S448735194   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103780Orig1s5194ltr.pdf 12/23/2015
AP012/22/2015S448865194   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103780s5194lbl.pdf 12/28/2015
AP09/27/2016SE8472045196   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103780s5196lbl.pdf 9/29/2016
AP09/27/2016SE8472425196   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103780Orig1s5196ltr.pdf 9/30/2016




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