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FDA Drug Application 022512 by BOEHRINGER INGELHEIM

Application Number022512
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/19/2010N28403000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm248694.htm 3/29/2011
AP010/19/2010N26712000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022512s000lbl.pdf 10/20/2010
AP010/19/2010N26715000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022512s000ltr.pdf 10/20/2010
AP010/19/2010N27073000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022512Orig1s000TOC.cfm 11/30/2010
AP010/19/2010N27914000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022512Orig1s000SumR.pdf 2/17/2011
AP010/19/2010N34826000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231720.pdf 1/3/2013
AP03/4/2011SLR28151004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s004lbl.pdf 3/7/2011
AP03/4/2011SLR28177004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s004ltr.pdf 3/8/2011
AP03/4/2011SLR36205004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022512Orig1s004.pdf 6/4/2013
AP04/5/2011SLR28481005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s005ltr.pdf 4/7/2011
AP011/9/2011SLR30549007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022512s007lbl.pdf 11/10/2011
AP011/9/2011SLR30560007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022512s007ltr.pdf 11/14/2011
AP01/17/2012SLR31414009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s009ltr.pdf 1/19/2012
AP01/17/2012SLR31471009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s009lbl.pdf 1/23/2012
AP04/27/2012SLR32572010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s010lbl.pdf 5/1/2012
AP04/27/2012SLR32573010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s010mg.pdf 5/1/2012
AP04/27/2012SLR32589010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s010ltr.pdf 5/2/2012
AP05/31/2012SLR32808011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512s011ltr.pdf 6/5/2012
AP05/31/2012SLR32891011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s011lbl.pdf 6/11/2012
AP05/31/2012SLR32892011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s011mg.pdf 6/11/2012
AP05/31/2012SLR35671011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022512Orig1s011_replace.pdf 4/10/2013
AP011/2/2012SLR34285014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512Orig1s014ltr.pdf 11/6/2012
AP011/2/2012SLR34296014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s014lbl.pdf 11/6/2012
AP011/2/2012SLR34297014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s014mg.pdf 11/6/2012
AP011/20/2012SCM       
AP012/19/2012SLR34745016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022512s016lbl.pdf 12/21/2012
AP012/19/2012SLR34754016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022512Orig1s016ltr.pdf 12/26/2012
AP04/25/2013SLR35868017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s017lbl.pdf 4/29/2013
AP04/25/2013SLR35881017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022512Orig1s017ltr.pdf 4/30/2013
AP04/4/2014SE839001018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s018lbl.pdf 4/8/2014
AP04/4/2014SE839017018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s018ltr.pdf 4/9/2014
AP010/18/2013SCM       
AP04/16/2014SCM       
AP012/10/2013SLR38000021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022512s021lbl.pdf 12/11/2013
AP012/10/2013SLR38024021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022512Orig1s021ltr.pdf 12/13/2013
AP07/25/2014SCM       
AP08/14/2014SLR40250023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s023ltr.pdf 8/15/2014
AP08/14/2014SLR40251023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s023lbl.pdf 8/15/2014
AP01/15/2015SLR41642024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s024ltr.pdf 1/20/2015
AP01/15/2015SLR41655024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s024lbl.pdf 1/20/2015
AP09/4/2014SLR40446025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022512Orig1s025ltr.pdf 9/8/2014
AP09/4/2014SLR40626025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022512s025.pdf 9/26/2014
AP04/7/2015SCM       
AP09/10/2015SLR43852027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s027lbl.pdf 9/11/2015
AP09/10/2015SLR43854027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s027ltr.pdf 9/14/2015
AP011/20/2015SE844561028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s028ltr.pdf 11/23/2015
AP011/20/2015SE844588028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s028lbl.pdf 11/25/2015
AP08/26/2015SLR43923031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512Orig1s031lbl.pdf 9/21/2015
AP08/26/2015SLR43739031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s031ltr.pdf 8/28/2015
AP09/23/2015SLR44301032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022512Orig1s032ltr.pdf 10/26/2015
AP09/23/2015SLR44307032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s032lbl.pdf 10/27/2015
AP07/28/2016SCM       




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