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FDA Drug Application 022078 by ABBVIE

Application Number022078
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/15/2008N19243000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022078lbl.pdf 2/20/2008
AP02/15/2008N19245000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022078s000ltr.pdf 2/21/2008
AP02/15/2008N20394000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022078s000TOC.cfm 7/31/2008
AP02/15/2008N20395000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022078s000_SumR.pdf 8/1/2008
AP02/15/2008N28972000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm 5/26/2011
AP07/24/2008SLR20301002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022078s002ltr.pdf 7/29/2008
AP07/24/2008SLR20314002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022078s002lbl.pdf 7/29/2008
AP07/28/2010SCM26064006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022078s006s007lbl.pdf 7/31/2010
AP07/28/2010SCM26088006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022078s006,s007ltr.pdf 8/2/2010
AP07/28/2010SCM27877006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022078_s006_s007_simcor.pdf 2/15/2011
AP07/28/2010SCM26089007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022078s006,s007ltr.pdf 8/2/2010
AP07/28/2010SCM26065007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022078s006s007lbl.pdf 7/31/2010
AP012/22/2010SCM27401008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022078s008ltr.pdf 12/28/2010
AP02/22/2011SLR27971010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022078s010ltr.pdf 2/28/2011
AP02/22/2011SLR28030010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022078s010lbl.pdf 3/4/2011
AP06/8/2011SLR29060012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022078s012ltr.pdf 6/8/2011
AP06/8/2011SLR29065012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022078s012lbl.pdf 6/8/2011
AP02/28/2012SLR31944013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022078s013ltr.pdf 2/28/2012
AP02/28/2012SLR31949013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022078s013lbl.pdf 2/28/2012
AP02/28/2012SLR31950013Tracked Changes Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022078S013-trackedchangeslbl.pdf 2/28/2012
AP02/28/2012SLR32299013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022078s013.pdf 3/30/2012
AP02/21/2013SLR35226015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020381Orig1s048,022078Orig1s015ltr.pdf 2/25/2013
AP02/21/2013SLR35258015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022078s015lbl.pdf 2/26/2013
AP010/31/2012SLR34229016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022078s016lbl.pdf 11/2/2012
AP010/31/2012SLR34274016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022078Orig1s016ltr.pdf 11/6/2012
AP01/5/2015SCM       




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