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FDA Drug Application 018878 by RECORDATI RARE

Application Number018878
Application Type New Drug Application
Sponsor ApplicantRECORDATI RARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/30/1985N       
AP010/31/1986SCM       
AP06/20/1985SLR       
AP06/8/1988SLR       
AP09/21/1994SLR       
AP09/13/1994SLR       
AP010/14/1997SCM       
AP05/15/1998SLR       
AP010/24/2000SCS       
AP011/16/2000SCS       
AP02/12/2001SCS       
AP05/6/2003SLR5762018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf 5/30/2003
AP05/6/2003SLR5763019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf 5/30/2003
AP011/8/2002SCS       
AP02/1/2006SLR13587023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018878s023lbl.pdf 2/7/2006
AP02/1/2006SLR13615023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018878s023ltr.pdf 2/8/2006
AP01/12/2007SLR15660024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018878s024lbl.pdf 1/16/2007
AP01/12/2007SLR15717024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018878s024ltr.pdf 1/25/2007
AP01/19/2010SLR24542027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018878s027lbl.pdf 1/20/2010
AP01/19/2010SLR24639027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018878s027ltr.pdf 1/26/2010




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