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FDA Drug Application 021455 by HOFFMANN LA ROCHE

Application Number021455
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
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
AP05/16/2003N5676000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21455_boniva_lbl.pdf 5/29/2003
AP05/16/2003N5863000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21455ltr.pdf 6/8/2003
AP05/16/2003N6017000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-455_Boniva.cfm 7/2/2003
AP05/16/2003N7098000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 12/9/2003
AP05/16/2003N27648000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM241518.pdf 2/1/2011
AP03/24/2005SE211286001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001lbl.pdf 3/25/2005
AP03/24/2005SE211287001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001ppi.pdf 3/25/2005
AP03/24/2005SE211293001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21455s001ltr.pdf 3/28/2005
AP06/13/2006SLR14340003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021455s003LTR.pdf 6/20/2006
AP02/13/2007SLR15868005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021455s005lbl.pdf 2/21/2007
AP02/13/2007SLR15882005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021455s005ltr.pdf 2/23/2007
AP011/28/2008SE121296007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021455s007ltr.pdf 11/28/2008
AP011/28/2008SE142090007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021455Orig1s007.pdf 3/11/2015
AP01/8/2010SLR24472009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021455s009lbl.pdf 1/8/2010
AP01/8/2010SLR24520009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021455s009ltr.pdf 1/15/2010
AP01/25/2011SLR27636011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021455s011lbl.pdf 1/31/2011
AP01/25/2011SLR27673011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021455s011ltr.pdf 2/2/2011
AP07/1/2011SLR29417013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021455s013ltr.pdf 7/6/2011
AP04/19/2013SLR35802014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf 4/23/2013
AP04/19/2013SLR35820014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021455Orig1s014,s015ltr.pdf 4/24/2013
AP04/19/2013SLR35821015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021455Orig1s014,s015ltr.pdf 4/24/2013
AP04/19/2013SLR35803015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf 4/23/2013
AP04/5/2013SCM       
AP06/18/2014SCM       
AP012/17/2014SLR41294018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021455Orig1s018ltr.pdf 12/18/2014
AP012/17/2014SLR41325018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021455s18lbl.pdf 12/19/2014
AP03/18/2015SLR42213019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021455Orig1s019ltr.pdf 3/19/2015
AP03/18/2015SLR42247019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s019lbl.pdf 3/24/2015
AP04/8/2015SLR42485020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf 4/10/2015
AP04/8/2015SLR42504020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021455Orig1s020ltr.pdf 4/13/2015




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