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FDA Drug Application 020647 by SOMERSET

Application Number020647
Application Type New Drug Application
Sponsor ApplicantSOMERSET
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/15/1996N       
AP08/6/1997SLR4280003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020647a_s01_s02_s03.pdf 8/6/1997
AP02/15/2001SCS       
AP012/31/2008SLR21513006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020647s006,020647s007ltr.pdf 1/6/2009
AP012/31/2008SLR45680006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf 4/14/2016
AP012/31/2008SLR45681007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020647s006s007lbl.pdf 4/14/2016
AP012/31/2008SLR21514007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020647s006,020647s007ltr.pdf 1/6/2009
AP05/20/2013SCM       




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