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FDA Drug Application 020954 by OTSUKA PHARM

Application Number020954
Application Type New Drug Application
Sponsor ApplicantOTSUKA PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/4/1999N706000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20954ltr.pdf 2/4/1999
AP02/4/1999N707000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20954.cfm 6/14/1999
AP02/4/1999N708000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20954lbl.pdf 2/4/1999
AP012/23/2002SLR3803001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954slr001ltr.pdf 12/23/2002
AP012/23/2002SLR7838001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20954-S001_BUSULFEX.pdf 3/9/2004
AP012/7/1999SCS       
AP04/24/2002SLR3806003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954s003.pdf 4/24/2002
AP04/24/2002SLR7839003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20954-S003_BUSULFEX.pdf 3/9/2004
AP01/13/2003SE24209004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020954s004lbl.pdf 3/6/2003
AP01/13/2003SE24838004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20954se2-004ltr.pdf 1/13/2003
AP01/13/2003SE29040004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-954S004_Busulfex.cfm 6/4/2004
AP011/13/2002SCP3808005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20954scp005ltr.pdf 11/13/2002
AP011/13/2002SCP3810005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20954scp005_busulfex_lbl.pdf 11/13/2002
AP011/13/2002SCP6114005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/20-954s005_Busulfex.cfm 7/8/2003
AP04/19/2007SCP16256008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020954s008lbl.pdf 4/20/2007
AP04/19/2007SCP16313008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020954s008_LTR.pdf 4/25/2007
AP06/23/2011SLR29326009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf 6/29/2011
AP06/23/2011SLR29365009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf 6/29/2011
AP06/23/2011SLR29327010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020954s009s010lbl.pdf 6/29/2011
AP06/23/2011SLR29366010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020954s009,s010ltr.pdf 6/29/2011
AP09/4/2014SCM       
AP01/16/2015SLR41648014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020954Orig1s014ltr.pdf 1/20/2015
AP01/16/2015SLR41652014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020954s014lbl.pdf 1/20/2015
AP010/28/2015SCM       
AP05/19/2016SLR46078016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020954Orig1s016ltr.pdf 5/20/2016
AP05/19/2016SLR46101016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020954s016lbl.pdf 5/23/2016




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