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FDA Drug Application 006695 by RECORDATI RARE

Application Number006695
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
AP03/15/1949N       
AP06/12/1978SDS       
AP02/19/1980SLR       
AP03/4/1982SCS       
AP02/21/1983SCP       
AP03/29/1986SPD       
AP01/15/1987SLR       
AP09/18/1987SLR       
AP01/12/1995SCS       
AP010/20/1994SCS       
AP03/22/1995SCS       
AP04/10/1995SCS       
AP012/13/1995SCM       
AP010/16/1998SCS       
AP010/16/1998SCS       
AP03/15/2000SLR       
AP011/17/2000SCS       
AP03/19/2003SLR4510030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/06695slr030ltr.pdf 3/26/2003
AP02/9/2004SLR7782031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/06695slr031ltr.pdf 3/2/2004
AP02/9/2004SLR8184031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/06695slr031_mustargen_lbl.pdf 4/5/2004




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