Back to FDA Applications sponsored by BOEHRINGER INGELHEIM

FDA Drug Application 021530 by BOEHRINGER INGELHEIM

Application Number021530
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/1/2004N8854000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21530_mobic_lbl.pdf 6/1/2004
AP06/1/2004N8868000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21530ltr.pdf 6/1/2004
AP06/1/2004N13770000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021530s000_MobicTOC.cfm 3/21/2006
AP06/1/2004N24019000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088646.pdf 11/19/2009
AP08/11/2005SE112591001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf 8/15/2005
AP08/11/2005SE112599001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf 8/15/2005
AP08/11/2005SLR12592003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020938s013,015,021530s001,003ltr.pdf 8/15/2005
AP08/11/2005SLR12600003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020938s013,015,021530s001,003lbl.pdf 8/15/2005
AP01/25/2007SLR15729005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020938s017,021530s005lbl.pdf 2/2/2007
AP01/25/2007SLR15748005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020938s017, 021530s005ltr.pdf 2/2/2007
AP06/27/2008SLR20106006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020938s018,021530s006lbl.pdf 6/30/2008
AP06/27/2008SLR20141006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020938s018, 021530s006ltr.pdf 7/1/2008
AP04/26/2010SLR25365007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021530s007lbl.pdf 4/28/2010
AP04/26/2010SLR25398007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s019,021530s007ltr.pdf 4/29/2010
AP07/29/2010SLR26081008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020938s020,021530s008lbl.pdf 8/1/2010
AP07/29/2010SLR26098008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020938s020,021530s008ltr.pdf 8/3/2010
AP08/3/2011SLR29686009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020938s021,021530s009ltr.pdf 8/5/2011
AP08/3/2011SLR29698009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020938s021,021530s009lbl.pdf 8/5/2011
AP03/5/2012SLR32056011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021530s011lbl.pdf 3/5/2012
AP03/5/2012SLR32084011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020938s022,021530s011ltr.pdf 3/12/2012
AP08/12/2014SCM       
AP05/9/2016SLR45960014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf 5/11/2016
AP05/9/2016SLR46016014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf 5/12/2016
AP05/9/2016SLR45961015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020938s024s025,021530s014s015lbl.pdf 5/11/2016
AP05/9/2016SLR46017015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020938Orig1s024,s025,021530Origs014,s015ltr.pdf 5/12/2016
AP09/1/2016SLR46969016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021530s016lbl.pdf 9/2/2016
AP09/1/2016SLR46972016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021530Orig1s016ltr.pdf 9/6/2016




Back to FDA Applications sponsored by BOEHRINGER INGELHEIM