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FDA Drug Application 019651 by APIL

Application Number019651
Application Type New Drug Application
Sponsor ApplicantAPIL
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
AP01/31/1992N       
AP05/27/1993SLR       
AP011/26/1995SCS       
AP05/6/1996SCM       
AP05/6/1996SCS       
AP08/19/1997SE15939005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/asacol_19651s5.cfm 6/18/2003
AP08/30/1996SLR       
AP011/25/1996SCS       
AP01/31/1997SCS       
AP07/8/1997SCM       
AP08/14/2000SLR       
AP08/14/2000SLR       
AP04/25/2000SCS       
AP09/5/2000SCS       
AP04/10/2007SLR16250016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019651s016LTR.pdf 4/20/2007
AP09/14/2009SLR23533020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019651s020lbl.pdf 10/6/2009
AP09/14/2009SLR23841020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019651s020ltr.pdf 11/12/2009
AP05/24/2010SLR25635023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019651s023ltr.pdf 5/28/2010
AP05/24/2010SLR25656023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019651s023lbl.pdf 5/28/2010
AP010/18/2013S37475024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019651Orig1s024ltr.pdf 10/21/2013
AP010/18/2013S37515024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019651s024lbl.pdf 10/22/2013
AP05/27/2015SE842932025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019651Orig1s025ltr.pdf 5/28/2015
AP05/27/2015SE842942025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019651s025lbl.pdf 5/29/2015
AP09/16/2015SCM       




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