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FDA Drug Application 020059 by ASTELLAS

Application Number020059
Application Type New Drug Application
Sponsor ApplicantASTELLAS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/18/1995N38189000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm234178.htm 12/27/2013
AP06/26/1995SCS       
AP010/2/1996SCM       
AP01/7/1997SCS       
AP012/10/1997SLR       
AP09/22/1998SCM       
AP010/26/1999SCS       
AP08/31/2001SE82635007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20059s7ltr.pdf 8/31/2001
AP08/31/2001SE85550007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20059s7lbl.pdf 4/30/2003
AP08/31/2001SE88583007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-059S007_Adenoscan.pdf 5/25/2004
AP02/1/2000SCM       
AP07/14/2005SLR12025011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf 7/21/2005
AP011/6/2009SLR24030014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020059s014lbl.pdf 11/19/2009
AP011/6/2009SLR24530014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020059s014ltr.pdf 1/19/2010
AP012/9/2013SCM       
AP01/3/2014SLR38218016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s016ltr.pdf 1/7/2014
AP01/3/2014SLR38225016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s016lbl.pdf 1/7/2014
AP08/20/2014SLR40296017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018ltr.pdf 8/21/2014
AP08/20/2014SLR40311017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf 8/22/2014
AP08/20/2014SLR40297018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020059Orig1s017,s018ltr.pdf 8/21/2014
AP08/20/2014SLR40312018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020059s017s018lbl.pdf 8/22/2014




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