Back to FDA Applications sponsored by RECORDATI RARE

FDA Drug Application 019998 by RECORDATI RARE

Application Number019998
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 CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/30/1991N       
AP05/11/1992SCM       
AP05/6/1992SLR       
AP02/25/1992SLR       
AP012/29/1992SLR       
AP04/14/1997SCM       
AP011/10/1998SCS       
AP03/4/1999SCS       
AP012/7/1999SCM       
AP010/5/1999SLR       
AP07/11/2007SLR17281013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019998s013ltr.pdf 7/16/2007
AP07/11/2007SLR17292013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf 7/16/2007
AP010/14/2010SLR26676017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019998s017ltr.pdf 10/19/2010
AP04/24/2014SCM       
AP07/25/2016SCM       




Back to FDA Applications sponsored by RECORDATI RARE