Back to FDA Applications sponsored by ASPEN GLOBAL

FDA Drug Application 009386 by ASPEN GLOBAL

Application Number009386
Application Type New Drug Application
Sponsor ApplicantASPEN GLOBAL
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
AP06/26/1954N       
AP011/21/1975SOA       
AP02/10/1977SCP       
AP011/8/1979SLR       
AP05/11/1981SLR       
AP05/19/1986SPD       
AP04/9/1987SLR       
AP04/9/1987SLR       
AP03/20/1990SCP       
AP09/17/1990SLR       
AP07/15/1991SLR7544013   http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/09386slr013_tabloid_lbl.pdf 1/15/2004
AP07/29/1994SLR       
AP012/23/1997SCM       
AP03/15/2000SLR       
AP09/6/2000SLR       
AP01/23/2003SCM6096019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/9-386s019_Myleran.cfm 7/8/2003
AP01/23/2003SCM4203019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/009386s019lbl.pdf 3/6/2003
AP01/23/2003SCM4782019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386scm019ltr.pdf 1/23/2003
AP09/20/2002SLR       
AP04/16/2003SLR5359021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr021_myleran_lbl.pdf 4/17/2003
AP04/16/2003SLR5642021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr021ltr.pdf 5/16/2003
AP012/24/2003SLR7489023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/09386slr023ltr.pdf 1/9/2004
AP012/24/2003SLR7653023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/09386slr023_myleran_lbl.pdf 2/3/2004




Back to FDA Applications sponsored by ASPEN GLOBAL