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FDA Drug Application 204677 by PIRAMAL IMAGING

Application Number204677
Application Type New Drug Application
Sponsor ApplicantPIRAMAL IMAGING
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/19/2014N38858000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s000lbl.pdf 3/20/2014
AP03/19/2014N38864000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s000ltr.pdf 3/21/2014
AP03/19/2014N39040000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204677Orig1s000TOC.cfm 4/14/2014
AP03/19/2014N39041000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204677Orig1s000SumR.pdf 4/14/2014
AP04/3/2014SLR38973001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204677Orig1s001ltr.pdf 4/4/2014
AP04/3/2014SLR39005001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204677s001lbl.pdf 4/8/2014
AP010/15/2014SCM       
AP010/15/2014SCM       
AP08/13/2014SCM       
AP05/4/2015SCM       
AP05/19/2015SCM       
AP05/18/2015SCM       
AP01/25/2016SCM       
AP09/29/2016SLR47277011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204677Orig1s011ltr.pdf 10/4/2016
AP09/29/2016SLR47288011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s011lbl.pdf 10/6/2016
AP08/25/2016SLR46889012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204677Orig1s012ltr.pdf 8/29/2016
AP08/25/2016SLR46903012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204677s012lbl.pdf 8/29/2016
AP03/8/2016SCM       




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