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FDA Drug Application 021395 by BOEHRINGER INGELHEIM

Application Number021395
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
AP01/30/2004N7826000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395_spiriva_lbl.pdf 3/3/2004
AP01/30/2004N7959000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21395ltr.pdf 3/16/2004
AP01/30/2004N8520000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm 5/6/2004
AP01/30/2004N9730000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107272.htm 7/13/2004
AP08/23/2004SLR10036001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21395s001ltr.pdf 8/25/2004
AP08/23/2004SLR10079001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21395s001lbl.pdf 8/25/2004
AP09/20/2006SLR14943007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s007lbl.pdf 9/21/2006
AP09/20/2006SLR14955007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s007ltr.pdf 9/25/2006
AP012/8/2006SLR15462008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf 12/14/2006
AP012/8/2006SLR15554008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s008, s015ltr.pdf 12/28/2006
AP03/3/2009SLR22052014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s014lbl.pdf 3/19/2009
AP03/3/2009SLR22053014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021395s014ltr.pdf 3/19/2009
AP012/8/2006SLR15463015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021395s008s015lbl.pdf 12/14/2006
AP012/8/2006SLR15555015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021395s008, s015ltr.pdf 12/28/2006
AP06/20/2008SLR20075022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021395s022ltr.pdf 6/25/2008
AP011/13/2008SLR21239027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021395s027lbl.pdf 11/18/2008
AP011/13/2008SLR21242027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021395s027ltr.pdf 11/18/2008
AP012/17/2009SE824304029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021395s029lbl.pdf 12/18/2009
AP012/17/2009SE824340029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021395s029ltr.pdf 12/24/2009
AP012/17/2009SE836179029   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/021395Orig1s029.pdf 6/3/2013
AP07/28/2011SLR29639033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021395s033lbl.pdf 7/29/2011
AP07/28/2011SLR29641033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021395s033ltr.pdf 8/1/2011
AP011/4/2011SLR       
AP010/26/2015SCM       
AP04/23/2015SCM       
AP04/22/2015SCM       
AP012/10/2015SLR44762040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021395Orig1s040ltr.pdf 12/14/2015
AP012/10/2015SLR44779040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021395s040lbl.pdf 12/15/2015
AP03/24/2016SCM       
AP04/29/2016SCM       
AP08/29/2016SCM       
AP06/23/2016SLR46412044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021395Orig1s044ltr.pdf 6/24/2016




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