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FDA Drug Application 020938 by BOEHRINGER INGELHEIM

Application Number020938
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
AP04/13/2000N657000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20938ltr.pdf 4/13/2000
AP04/13/2000N658000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20938lbl.pdf 4/13/2000
AP04/13/2000N3622000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-938_Mobic.cfm 7/18/2001
AP04/13/2000N24018000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf 11/19/2009
AP08/23/2000SCF       
AP011/14/2000SCM       
AP012/15/2000SCS       
AP07/16/2004SE19770004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20938s004ltr.pdf 7/21/2004
AP07/16/2004SE19816004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20938s004lbl.pdf 7/21/2004
AP01/10/2002SCM       
AP06/10/2002SCP       
AP04/28/2003SLR5576007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020938s007lbl.pdf 5/6/2003
AP04/28/2003SLR5737007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20938slr007ltr.pdf 5/29/2003
AP011/21/2002SCS       
AP012/13/2002SCM       
AP08/11/2005SE112593013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf 8/15/2005
AP08/11/2005SE112601013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf 8/15/2005
AP08/11/2005SLR12594015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf 8/15/2005
AP08/11/2005SLR12602015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf 8/15/2005
AP01/25/2007SLR15730017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020938s017,021530s005lbl.pdf 2/2/2007
AP01/25/2007SLR15749017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020938s017, 021530s005ltr.pdf 2/2/2007
AP06/27/2008SLR20107018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020938s018,021530s006lbl.pdf 6/30/2008
AP06/27/2008SLR20140018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020938s018, 021530s006ltr.pdf 7/1/2008
AP04/26/2010SLR25364019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s019lbl.pdf 4/28/2010
AP04/26/2010SLR25397019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s019,021530s007ltr.pdf 4/29/2010
AP07/29/2010SLR26082020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s020,021530s008lbl.pdf 8/1/2010
AP07/29/2010SLR26097020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s020,021530s008ltr.pdf 8/3/2010
AP08/3/2011SLR29685021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020938s021,021530s009ltr.pdf 8/5/2011
AP08/3/2011SLR29699021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020938s021,021530s009lbl.pdf 8/5/2011
AP03/5/2012SLR32053022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020938s022lbl.pdf 3/5/2012
AP03/5/2012SLR32083022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020938s022,021530s011ltr.pdf 3/12/2012
AP05/9/2016SLR45958024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf 5/11/2016
AP05/9/2016SLR46014024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf 5/12/2016
AP05/9/2016SLR45959025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf 5/11/2016
AP05/9/2016SLR46015025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf 5/12/2016
AP06/30/2016SLR46446026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s026ltr.pdf 7/1/2016
AP06/30/2016SLR46461026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s026lbl.pdf 7/5/2016




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