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FDA Drug Application 021906 by ABBVIE

Application Number021906
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/28/2005N12995000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021906lbl.pdf 11/1/2005
AP010/28/2005N13005000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021906ltr.pdf 11/1/2005
AP010/28/2005N24001000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM310187.pdf 11/19/2009
AP010/28/2005N17296000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021906s000TOC.cfm 7/18/2007
AP04/20/2007SE816300002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s012,021906s002lbl.pdf 4/25/2007
AP04/20/2007SE816308002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s012, 021906s002_LTR.pdf 4/25/2007
AP012/21/2006SLR15515003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021906s003,021251s013lbl.pdf 12/28/2006
AP012/21/2006SLR15589003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021906s003, 21251s013ltr.pdf 1/8/2007
AP03/2/2007SLR15969004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s014, 021906s004ltr.pdf 3/7/2007
AP03/2/2007SLR15985004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s014,021906s004lbl.pdf 3/7/2007
AP06/29/2007SLR16877005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s016,021906s00533ltr.pdf 7/5/2007
AP06/29/2007SLR16950005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s016,021906s005lbl.pdf 7/5/2007
AP011/9/2007SE218421007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s018,021906s007lbl.pdf 11/19/2007
AP011/9/2007SE218459007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s018, 021906s007ltr.pdf 11/19/2007
AP09/25/2007SLR18034008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021906s008,021251s019lbl.pdf 9/26/2007
AP09/25/2007SLR18151008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021906s008, 021251s019ltr.pdf 10/4/2007
AP06/20/2008SLR20067013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s022, 021906s013ltr.pdf 6/24/2008
AP06/20/2008SLR20084013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021251s022,021906s013lbl.pdf 6/26/2008
AP04/6/2009SLR22228014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s014,021251s023ltr.pdf 4/10/2009
AP04/6/2009SLR22273014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.pdf 4/16/2009
AP010/3/2008SLR20973015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021906s015, 021251s024ltr.pdf 10/8/2008
AP010/3/2008SLR21009015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021906s015,021251s024lbl.pdf 10/9/2008
AP04/20/2009SE822312017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s026,021906s017lbl.pdf 4/23/2009
AP04/20/2009SE822319017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s017,021251s026ltr.pdf 4/24/2009
AP01/29/2010SLR24703022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.pdf 2/4/2010
AP01/29/2010SLR24740022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s029,021906s022ltr.pdf 2/5/2010
AP04/27/2010SE525446024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021906s024,021251s031ltr.pdf 5/3/2010
AP04/27/2010SE525511024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s024,021251s031lbl.pdf 5/7/2010
AP06/14/2010SLR25741026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s026lbl.pdf 6/15/2010
AP06/14/2010SLR25750026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s033,021906s026ltr.pdf 6/16/2010
AP02/24/2011SLR27990032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s039,021906s032ltr.pdf 3/1/2011
AP02/24/2011SLR28048032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021251s039,021906s032lbl.pdf 3/4/2011
AP05/6/2011SLR28778033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s040,21906s033ltr.pdf 5/10/2011
AP04/20/2012SLR32511034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034lbl.pdf 4/24/2012
AP04/20/2012SLR32512034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034mg.pdf 4/24/2012
AP04/20/2012SLR32528034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s034,021251s041ltr.pdf 4/24/2012
AP02/17/2012SLR31857035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s042,021906s035lbl.pdf 2/22/2012
AP02/17/2012SLR31895035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021251s042,021906s035ltr.pdf 2/27/2012
AP05/16/2012SLR32701036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044lbl.pdf 5/17/2012
AP05/16/2012SLR32702036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044mg.pdf 5/17/2012
AP05/16/2012SLR32712036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s036,021251s044ltr.pdf 5/18/2012
AP011/30/2012SCM       
AP01/17/2013SLR34901038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s038,021251Orig1s045ltr.pdf 1/22/2013
AP01/17/2013SLR34924038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s045,021906s038lbl.pdf 1/22/2013
AP011/7/2013SLR37765039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s039,021251Orig1s046ltr.pdf 11/8/2013
AP011/7/2013SLR37779039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf 11/8/2013
AP01/28/2015SE841716040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s040,021251Orig1s047ltr.pdf 1/29/2015
AP01/28/2015SE841744040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s047,021906s040lbl.pdf 1/30/2015
AP06/26/2015SE843177042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf 7/1/2015
AP06/26/2015SE843249042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s042,021251Orig1s049ltr.pdf 7/6/2015
AP03/27/2015SLR42346043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s050,021906Orig1s043ltr.pdf 4/1/2015
AP03/27/2015SLR42403043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s050,021906s043lbl.pdf 4/2/2015
AP011/10/2015SLR44457044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.pdf 11/12/2015
AP011/10/2015SLR44490044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s051,021906Orig1s044ltr.pdf 11/17/2015
AP012/2/2015SCM       
AP09/15/2016SLR47081047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s053,021906Orig1s047ltr.pdf 9/20/2016
AP09/15/2016SLR47123047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s053,021906s047lbl.pdf 9/20/2016




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