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FDA Drug Application 010841 by RECORDATI RARE

Application Number010841
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
AP04/22/1957N       
AP02/5/1980SCS       
AP07/12/1982SCP       
AP011/4/1982SCS       
AP010/28/1983SCM       
AP011/13/1984SCS       
AP09/26/2003SLR6729013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf 10/1/2003
AP09/26/2003SLR6730014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10841slr013,014ltr.pdf 10/1/2003
AP05/13/1998SCP       
AP04/4/2002SCM       
AP012/10/2002SCS       
AP02/2/2007SLR15799020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/010841s020LTR.pdf 2/12/2007
AP02/2/2007SLR15852020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/010841s020lbl.pdf 2/21/2007
AP04/23/2009SLR22343021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010841s021lbl.pdf 4/28/2009
AP04/23/2009SLR22354021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010841s021ltr.pdf 4/29/2009
AP06/7/2010SLR25727022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022lbl.pdf 6/14/2010
AP06/7/2010SLR25729022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010841s022ltr.pdf 6/14/2010
AP06/7/2010SLR25774022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010841s022MedGuide.pdf 6/24/2010
AP05/31/2011SLR29017023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010841s023ltr.pdf 6/2/2011
AP01/23/2013SCM       




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