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FDA Drug Application 020576 by RARE DIS THERAP

Application Number020576
Application Type New Drug Application
Sponsor ApplicantRARE DIS THERAP
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
AP010/25/1996N       
AP05/5/1998SLR       
AP08/13/1998SCS       
AP03/16/1999SLR       
AP01/21/2000SCM       
AP08/25/2000SCP       
AP02/17/2006SLR13666008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020576s008lbl.pdf 2/28/2006
AP02/17/2006SLR13699008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020576s008ltr.pdf 3/1/2006
AP04/5/2010SLR25217010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020576s010lbl.pdf 4/5/2010
AP04/5/2010SLR25233010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020576s010ltr.pdf 4/8/2010




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