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FDA Drug Application 050709 by ASTELLAS

Application Number050709
Application Type New Drug Application
Sponsor ApplicantASTELLAS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/8/1994N6625000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050709_prograf_toc.cfm 9/10/2003
AP06/22/1995SCS       
AP04/25/1996SLR       
AP04/22/1997SE2       
AP04/22/1997SE1       
AP04/20/1998SCS       
AP012/1/2000SE85568010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf 5/2/2003
AP07/25/2001SLR5569012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s12lbl.pdf 5/2/2003
AP06/16/2004SLR9492013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50708slr021,50709slr013ltr.pdf 6/23/2004
AP06/16/2004SLR9506013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf 6/23/2004
AP012/13/2005SLR13288018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050708s025,050709s018ltr.pdf 12/16/2005
AP03/29/2006SE113841019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s024, 050709s019ltr.pdf 4/5/2006
AP04/27/2006SLR14009020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf 5/1/2006
AP04/27/2006SLR14025020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s026, 050709s020LTR.pdf 5/1/2006
AP05/19/2009SLR22600021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf 5/21/2009
AP05/19/2009SLR22640021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s027,050709s021ltr.pdf 5/27/2009
AP05/19/2009SLR34037021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050709Orig1s021_StatR.pdf 10/11/2012
AP05/19/2009SLR34040021Medical Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050709Orig1s021_MedR.pdf 10/11/2012
AP02/13/2009SLR21862026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s034,050709s026ltr.pdf 2/18/2009
AP02/13/2009SLR21895026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf 2/20/2009
AP07/14/2011SLR29526028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf 7/18/2011
AP07/14/2011SLR29549028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf 7/19/2011
AP07/14/2011SLR29527030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf 7/18/2011
AP07/14/2011SLR29550030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf 7/19/2011
AP02/6/2012SLR31693031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050709s031lbl.pdf 2/6/2012
AP02/6/2012SLR31713031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s038,050709s031ltr.pdf 2/8/2012
AP07/5/2012SLR33094033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s040,050709s033ltr.pdf 7/9/2012
AP07/5/2012SLR33111033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf 7/10/2012
AP08/14/2012SLR33451034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708Orig1s041,050709Orig1s034ltr.pdf 8/15/2012
AP08/14/2012SLR33479034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf 8/15/2012
AP08/16/2013SCM       
AP09/4/2013SLR36990036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050708Orig1s043,050709Orig1s036ltr.pdf 9/9/2013
AP09/4/2013SLR37013036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf 9/9/2013
AP07/1/2015SCM       
AP05/19/2015SLR42857038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050708Orig1s045,050709Orig1s038ltr.pdf 5/21/2015
AP05/19/2015SLR42861038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf 5/21/2015




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