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FDA Drug Application 103411 by SIGMA TAU

Application Number103411
Application Type Biologic License Application
Sponsor ApplicantSIGMA TAU
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
AP02/1/1994N       
AP07/24/2006S145195052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103411s5052lbl.pdf 7/24/2006
AP07/24/2006S146105052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103411s5052ltr.pdf 8/4/2006
AP03/23/2011S309225126   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103411s5126lbl.pdf 12/12/2011
AP04/22/2014SLR391225180   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103411Orig1s5180ltr.pdf 4/23/2014
AP04/22/2014SLR391245180   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103411s5180lbl.pdf 4/23/2014
AP010/7/2016SLR473345188   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103411Orig1s5188ltr.pdf 10/12/2016
AP010/7/2016SLR473365188   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103411s5188lbl.pdf 10/12/2016




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