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FDA Drug Application 020863 by OTSUKA

Application Number020863
Application Type New Drug Application
Sponsor ApplicantOTSUKA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/15/1999N434000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/cilostazol_letter.pdf 1/15/1999
AP01/15/1999N435000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20863.cfm 1/15/1999
AP01/15/1999N9363000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/cilo_label.htm 6/14/2004
AP03/31/1999SCM       
AP02/16/2000SCS       
AP06/26/2000SCS       
AP07/7/2000SCM       
AP012/27/2000SCM       
AP03/7/2001SCS       
AP02/4/2004SLR7801007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20863slr007ltr.pdf 3/3/2004
AP09/20/2002SCM       
AP011/23/2005SLR13142011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020863s011lbl.pdf 11/30/2005
AP011/23/2005SLR13159011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020863s011ltr.pdf 11/30/2005
AP01/18/2007SE815700019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s019lbl.pdf 1/24/2007
AP01/18/2007SE815710019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020863s019ltr.pdf 1/25/2007
AP011/13/2007SLR18424021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020863s021lbl.pdf 11/19/2007
AP011/13/2007SLR18455021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020863s021ltr.pdf 11/19/2007
AP01/23/2015SLR41677022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020863Orig1s022ltr.pdf 1/26/2015
AP01/23/2015SLR41730022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s022lbl.pdf 1/29/2015
AP07/30/2015SLR43549023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020863Orig1s023ltr.pdf 7/31/2015
AP07/30/2015SLR43569023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020863s023lbl.pdf 8/4/2015




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