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FDA Drug Application 010669 by ASPEN GLOBAL INC

Application Number010669
Application Type New Drug Application
Sponsor ApplicantASPEN GLOBAL INC
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
AP03/18/1957N       
AP03/9/1977SCS       
AP02/15/1979SCS       
AP03/22/1978SCS       
AP06/8/1978SCP       
AP08/27/1981SLR       
AP03/12/1984SPD       
AP09/22/1986SLR       
AP03/6/1990SCP       
AP02/28/1989SLR       
AP010/14/1992SCS       
AP02/9/1996SLR       
AP02/4/1994SCM       
AP06/29/1995SCS       
AP07/24/2001SCM2782021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf 7/24/2001
AP07/24/2001SCS2783022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf 7/24/2001
AP07/24/2001SCF2784023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s21s22s23ltr.pdf 7/24/2001
AP06/20/2001SLR2785024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10669s24ltr.pdf 6/20/2001
AP011/14/2002SCM       
AP011/13/2003SLR6926028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/10669slr028ltr.pdf 11/25/2003
AP011/13/2003SLR7013028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/10669slr028_leukeran_lbl.pdf 12/2/2003
AP05/24/2005SLR11699029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010669s029ltr.pdf 5/25/2005
AP04/23/2010SLR25373030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010669s030ltr.pdf 4/28/2010
AP04/23/2010SLR25422030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010669s030lbl.pdf 5/3/2010
AP010/28/2011SLR30445032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/010669s032lbl.pdf 11/1/2011
AP010/28/2011SLR30479032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010669s032ltr.pdf 11/3/2011




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