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FDA Drug Application 201152 by BOEHRINGER INGELHEIM

Application Number201152
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
AP03/25/2011N28397000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s000lbl.pdf 3/29/2011
AP03/25/2011N28399000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201152s000ltr.pdf 3/29/2011
AP03/25/2011N30641000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089818.pdf 11/17/2011
AP03/25/2011N33058000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201152Orig1s000TOC.cfm 6/29/2012
AP03/25/2011N33059000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201152Orig1s000SumR.pdf 6/29/2012
AP05/6/2011SLR28776001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf 5/10/2011
AP011/9/2011SLR30553002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201152s002lbl.pdf 11/10/2011
AP011/9/2011SLR30564002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201152s002ltr.pdf 11/14/2011
AP011/8/2012S34338004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s004lbl.pdf 11/8/2012
AP011/8/2012S34339004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s004mg.pdf 11/8/2012
AP011/8/2012S34358004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201152Orig1s004ltr.pdf 11/13/2012
AP09/28/2012SE833953005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201152Orig1s005ltr.pdf 10/3/2012
AP09/28/2012SE833978005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s005lbl.pdf 10/4/2012
AP09/28/2012SE833979005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201152s005mg.pdf 10/4/2012
AP01/27/2014SLR38382007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201152Orig1s007ltr.pdf 1/28/2014
AP01/27/2014SLR38392007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201152s007lbl.pdf 1/28/2014




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