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FDA Drug Application 050682 by RECORDATI RARE

Application Number050682
Application Type New Drug Application
Sponsor ApplicantRECORDATI RARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/10/1964N       
AP03/22/1988SLR       
AP02/17/1997SLR       
AP02/18/1997SLR       
AP02/14/1996SCM       
AP06/6/1997SCS       
AP06/7/2000SLR       
AP03/13/1998SCM       
AP05/22/1998SCS       
AP02/8/1999SCS       
AP01/22/2001SLR       
AP02/14/2001SCS       
AP010/28/2002SLR2594019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50682slr019ltr.pdf 10/28/2002
AP03/19/2003SLR4497020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50682slr020ltr.pdf 3/26/2003
AP011/30/2004SLR10729021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50682s021ltr.pdf 12/6/2004
AP08/17/2005SLR12634022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050682s022ltr.pdf 8/19/2005
AP03/13/2009SLR22009025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050682s025ltr.pdf 3/17/2009
AP03/13/2009SLR22189025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050682s025lbl.pdf 4/3/2009
AP02/3/2012SLR31663029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf 2/6/2012
AP02/3/2012SLR31708029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf 2/7/2012
AP02/3/2012SLR31709030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050682s029,s030ltr.pdf 2/7/2012
AP02/3/2012SLR31664030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050682s029s030lbl.pdf 2/6/2012
AP04/7/2015SCM       




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