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FDA Drug Application 020850 by BOEHRINGER INGELHEIM

Application Number020850
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
AP011/10/1998N389000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20850ltr.pdf 11/10/1998
AP011/10/1998N390000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20850lbl.pdf 11/10/1998
AP011/10/1998N3589000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20850_Micardis.cfm 8/6/2001
AP011/10/1998N31209000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm218897.htm 12/22/2011
AP010/29/1999SCM       
AP012/2/1999SCM       
AP04/4/2000SCM       
AP010/12/2000SCS       
AP010/23/2003SLR6857005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20850slr005ltr.pdf 10/31/2003
AP03/30/2004SLR8304011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20850slr011ltr.pdf 4/7/2004
AP03/30/2004SLR8521011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020850s011lbl.pdf 5/6/2004
AP09/2/2005SLR12745013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020850s013lbl.pdf 9/8/2005
AP09/2/2005SLR12746013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020850s013ltr.pdf 9/8/2005
AP02/27/2007SLR15964019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020850s019ltr.pdf 3/6/2007
AP08/11/2009SLR23390022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf 9/17/2009
AP08/11/2009SLR23990022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s022,s023ltr.pdf 11/19/2009
AP08/11/2009SLR23391023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf 9/17/2009
AP08/11/2009SLR23991023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s022,s023ltr.pdf 11/19/2009
AP010/16/2009SE123656025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s025lbl.pdf 10/21/2009
AP010/16/2009SE124084025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020850s025ltr.pdf 11/20/2009
AP01/18/2012SLR31432031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850s031ltr.pdf 1/23/2012
AP01/18/2012SLR31468031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s031lbl.pdf 1/23/2012
AP07/6/2011SLR29443032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020850s032ltr.pdf 7/7/2011
AP07/6/2011SLR29487032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020850s032lbl.pdf 7/12/2011
AP09/20/2012SLR33824033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850Orig1s033ltr.pdf 9/24/2012
AP09/20/2012SLR33831033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s033lbl.pdf 9/24/2012
AP01/19/2012SLR31433035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850s035ltr.pdf 1/23/2012
AP01/19/2012SLR31450035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s035lbl.pdf 1/23/2012
AP010/24/2012SLR34175036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020850Orig1s036ltr.pdf 10/26/2012
AP010/24/2012SLR34189036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020850s036lbl.pdf 10/26/2012
AP02/16/2015SCM       
AP012/12/2014SLR41247038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020850Orig1s038ltr.pdf 12/15/2014
AP012/12/2014SLR41257038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020850s038lbl.pdf 12/15/2014
AP08/5/2015SCM       




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