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FDA Drug Application 019818 by SIGMA TAU

Application Number019818
Application Type New Drug Application
Sponsor ApplicantSIGMA TAU
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/21/1990N       
AP011/28/1990SCS       
AP06/10/1991SCS       
AP09/27/1991SLR       
AP04/13/1992SCE       
AP04/22/1992SCS       
AP03/9/1993SCS       
AP012/28/1992SCS       
AP011/10/1992SLR       
AP08/11/1993SCF       
AP06/16/1994SCS       
AP012/6/1993SCS       
AP09/16/1998SCS       
AP08/17/2001SCS       
AP04/15/2002SCM       
AP010/26/2007SLR18321034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf 11/7/2007
AP010/26/2007SLR18397034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019818s034ltr.pdf 11/8/2007
AP09/25/2008SLR20900042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019818s042ltr.pdf 9/29/2008
AP09/25/2008SLR20935042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf 10/3/2008
AP01/15/2013SCM       
AP010/7/2013SCM       
AP010/15/2013SCM       
AP01/10/2014SCM       
AP012/17/2013SCM       
AP03/4/2014SCM       
AP06/5/2014SLR39492053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf 6/10/2014
AP06/5/2014SLR39500053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019818Orig1s053ltr.pdf 6/11/2014
AP07/17/2014SCM       
AP012/21/2015SCM       




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