Back to FDA Applications sponsored by ASTELLAS

FDA Drug Application 050708 by ASTELLAS

Application Number050708
Application Type New Drug Application
Sponsor ApplicantASTELLAS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/8/1994N6626000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/050708_prograf_toc.cfm 9/10/2003
AP06/22/1995SCP       
AP06/22/1995SCS       
AP06/22/1995SCP       
AP04/25/1996SLR       
AP04/22/1997SE2       
AP04/22/1997SE1       
AP04/20/1998SCS       
AP08/24/1998SCS9343010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50709s10lbl.pdf 6/14/2004
AP08/24/1998SCF       
AP012/1/2000SE85564013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s13lbl.pdf 5/2/2003
AP05/8/2001SCM       
AP07/25/2001SLR5566015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf 5/2/2003
AP07/25/2001SLR5567016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50708s15s16lbl.pdf 5/2/2003
AP010/24/2002SCS       
AP06/16/2004SLR9491021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50708slr021,50709slr013ltr.pdf 6/23/2004
AP06/16/2004SLR9505021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50708slr021,50709slr013_prograf_lbl.pdf 6/23/2004
AP03/29/2006SE113840024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s024, 050709s019ltr.pdf 4/5/2006
AP012/13/2005SLR13289025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050708s025,050709s018ltr.pdf 12/16/2005
AP04/27/2006SLR14008026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050708s026,050709s020lbl.pdf 5/1/2006
AP04/27/2006SLR14024026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050708s026, 050709s020LTR.pdf 5/1/2006
AP05/19/2009SLR22599027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s027,050709s021lbl.pdf 5/21/2009
AP05/19/2009SLR22639027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s027,050709s021ltr.pdf 5/27/2009
AP05/19/2009SLR34038027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050708Orig1s027_StatR.pdf 10/11/2012
AP05/19/2009SLR34039027Medical Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/050708Orig1s027_MedR.pdf 10/11/2012
AP02/13/2009SLR21861034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050708s034,050709s026ltr.pdf 2/18/2009
AP02/13/2009SLR21894034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050708s034,050709s026lbl.pdf 2/20/2009
AP07/14/2011SLR29547036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf 7/19/2011
AP07/14/2011SLR29528036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf 7/18/2011
AP07/14/2011SLR29529037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050708s036s037,050709s028s030lbl.pdf 7/18/2011
AP07/14/2011SLR29548037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050708s036s037,050709s028s030ltr.pdf 7/19/2011
AP02/6/2012SLR31692038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s038lbl.pdf 2/6/2012
AP02/6/2012SLR31712038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s038,050709s031ltr.pdf 2/8/2012
AP07/5/2012SLR33093040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708s040,050709s033ltr.pdf 7/9/2012
AP07/5/2012SLR33112040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s040,050709s033lbl.pdf 7/10/2012
AP08/14/2012SLR33450041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050708Orig1s041,050709Orig1s034ltr.pdf 8/15/2012
AP08/14/2012SLR33478041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050708s041,050709s034lbl.pdf 8/15/2012
AP01/28/2013SCM       
AP09/4/2013SLR36989043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050708Orig1s043,050709Orig1s036ltr.pdf 9/9/2013
AP09/4/2013SLR37014043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050708s043,050709s036lbl.pdf 9/9/2013
AP03/19/2014SCM       
AP05/19/2015SLR42856045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050708Orig1s045,050709Orig1s038ltr.pdf 5/21/2015
AP05/19/2015SLR42860045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050708s045,050709s038lbl.pdf 5/21/2015




Back to FDA Applications sponsored by ASTELLAS

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.