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FDA Drug Application 021903 by RECORDATI RARE

Application Number021903
Application Type New Drug Application
Sponsor ApplicantRECORDATI RARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/13/2006N13938000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021903lbl.pdf 4/14/2006
AP04/13/2006N19702000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/21-903s000TOC.cfm 4/22/2008
AP09/12/2008SLR20776003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021903s003ltr.pdf 9/16/2008
AP012/22/2009SLR24384004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021903s004ltr.pdf 12/31/2009
AP012/22/2009SLR24394004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021903s004lbl.pdf 1/4/2010
AP02/28/2013SCM       
AP012/3/2013SLR37963008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021903s008lbl.pdf 12/4/2013
AP012/3/2013SLR37977008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021903Orig1s008ltr.pdf 12/5/2013
AP01/13/2016SLR44967009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021903Orig1s009ltr.pdf 1/15/2016
AP01/13/2016SLR45036009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021903s009lbl.pdf 1/26/2016




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