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FDA Drug Application 020579 by BOEHRINGER INGELHEIM

Application Number020579
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
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
AP04/15/1997N25037000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020579_s000.pdf 3/16/2010
AP08/25/1997SCS       
AP05/26/1998SLR       
AP012/8/1998SCS       
AP01/19/1999SCM       
AP02/23/1999SCS       
AP09/2/1999SCM       
AP05/1/2001SLR       
AP06/30/2000SCM       
AP07/26/2000SCP       
AP06/6/2001SCS       
AP08/20/2001SCM       
AP012/17/2001SCS       
AP010/18/2005SLR12950016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020579s016lbl.pdf 10/24/2005
AP010/18/2005SLR12976016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020579s016ltr.pdf 10/25/2005
AP01/11/2007SLR15656020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s020lbl.pdf 1/16/2007
AP01/11/2007SLR15661020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s020ltr.pdf 1/16/2007
AP02/16/2007SLR15861021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020579s021lbl.pdf 2/21/2007
AP02/16/2007SLR15892021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020579s021ltr.pdf 2/23/2007
AP04/29/2008SLR19759023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s023ltr.pdf 5/5/2008
AP012/2/2008SLR21317024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020579s024ltr.pdf 12/4/2008
AP010/29/2009SLR23715025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s025lbl.pdf 10/30/2009
AP010/29/2009SLR23967025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s025ltr.pdf 11/19/2009
AP012/22/2009SE824351026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020579s026ltr.pdf 12/29/2009
AP012/22/2009SE824396026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020579s026lbl.pdf 1/4/2010
AP07/25/2011SLR29616027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020579s027lbl.pdf 7/27/2011
AP07/25/2011SLR29617027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020579s027ltr.pdf 7/27/2011
AP07/20/2014SLR39982028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s028lbl.pdf 7/24/2014
AP07/20/2014SLR39988028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s028ltr.pdf 7/24/2014
AP010/21/2014SLR40840029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020579s029lbl.pdf 10/21/2014
AP010/21/2014SLR40860029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020579Orig1s029ltr.pdf 10/22/2014
AP01/21/2016SCM       
AP09/9/2016SCM       




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