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FDA Drug Application 020291 by BOEHRINGER INGELHEIM

Application Number020291
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/24/1996N       
AP04/8/1997SCS       
AP010/14/1997SCM       
AP011/26/1997SCM       
AP03/23/1999SCS       
AP06/19/1998SCS       
AP02/22/1999SCM       
AP08/18/1999SCS       
AP09/16/1999SCM       
AP07/23/2001SCS       
AP06/1/2006SLR14214020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020291s020LTR.pdf 6/2/2006
AP06/1/2006SLR14219020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020291s020lbl.pdf 6/2/2006
AP011/10/2008SLR21209023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020291s023lbl.pdf 11/12/2008
AP011/10/2008SLR21223023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020291s023ltr.pdf 11/13/2008
AP05/7/2009SLR22477026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s026lbl.pdf 5/11/2009
AP05/7/2009SLR22543026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s026ltr.pdf 5/13/2009
AP06/2/2009SLR22689027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020291s027lbl.pdf 6/4/2009
AP06/2/2009SLR22714027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020291s027ltr.pdf 6/8/2009
AP04/1/2011SLR28439029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020291s029lbl.pdf 4/1/2011
AP04/1/2011SLR28466029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020291s029ltr.pdf 4/6/2011
AP09/17/2012N33797030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s030ltr.pdf 9/20/2012
AP08/20/2012SLR33533031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020291s031lbl.pdf 8/20/2012
AP08/20/2012SLR33536031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020291Orig1s031ltr.pdf 8/22/2012




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