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FDA Drug Application 018723 by ABBVIE

Application Number018723
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/10/1983N19044000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm 2/1/2008
AP03/10/1983N35363000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM342868.pdf 3/8/2013
AP010/26/1984SCF       
AP08/11/1986SLR       
AP012/6/1985SCS       
AP08/11/1986SLR       
AP012/23/1985SCE       
AP011/24/1986SCE       
AP08/17/1988SCS       
AP03/21/1989SCE       
AP08/16/1989SCM       
AP03/18/1994SCM       
AP06/22/1994SCS       
AP03/18/1996SE1       
AP03/23/1995SCS       
AP06/20/1996SE1       
AP012/2/1996SCS       
AP012/24/1997SCF       
AP05/8/1998SCP       
AP04/2/1998SCM       
AP09/22/1998SCS       
AP06/19/2000SLR       
AP012/12/2002SLR8888029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116 6/2/2004
AP011/5/2002SCS       
AP012/9/2002SCS       
AP01/11/2006SLR13386032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf 1/13/2006
AP01/11/2006SLR13448032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018723s032ltr.pdf 1/20/2006
AP010/13/2006SLR15120033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf 10/18/2006
AP010/13/2006SLR15196033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf 10/23/2006
AP010/7/2011SLR30273037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf 10/12/2011
AP010/7/2011SLR30307037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf 10/13/2011
AP04/23/2009SLR22379039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018723s039ltr.pdf 5/1/2009
AP04/23/2009SLR22523039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018723s039lbl.pdf 5/12/2009
AP010/7/2011SLR30308040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf 10/13/2011
AP010/7/2011SLR30274040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf 10/12/2011
AP06/19/2014SLR39614041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf 6/23/2014
AP06/19/2014SLR39642041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s041lbl.pdf 6/23/2014
AP010/7/2011SLR30275043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf46lbl.pdf 10/12/2011
AP010/7/2011SLR30309043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf 10/13/2011
AP010/7/2011SLR30310045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf 10/13/2011
AP010/7/2011SLR30276045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf 10/12/2011
AP010/7/2011SLR30277046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018723s037lbl.pdf 10/12/2011
AP010/7/2011SLR30311046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018081s046,s048,s050,s052,018082s031,s033,s035,s037,018723s037,s040,s043,s045,s046,019680s025,s027,s029,s031,020593s016,s020,s023ltr.pdf 10/13/2011
AP02/27/2013SLR35284047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf 3/1/2013
AP02/27/2013SLR35330047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s047lbl.pdf 3/4/2013
AP07/31/2013SLR37130048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf 9/17/2013
AP07/31/2013SLR37131048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s048lbl.pdf 9/17/2013
AP06/14/2013SLR36414049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018723s049lbl.pdf 7/2/2013
AP011/20/2014SLR41076050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf 11/24/2014
AP011/20/2014SLR41148050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s050lbl.pdf 12/3/2014
AP01/7/2015SLR41524051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf 1/8/2015
AP01/7/2015SLR41536051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s051lbl.pdf 1/8/2015
AP06/9/2014SLR39474052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf 6/10/2014
AP06/9/2014SLR39517052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf 6/11/2014
AP08/20/2014SLR40292053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf 8/21/2014
AP08/20/2014SLR40306053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018723s053lbl.pdf 8/22/2014
AP03/13/2015SLR42157054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf 3/17/2015
AP03/13/2015SLR42186054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.pdf 3/17/2015
AP09/23/2015SLR43993055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf 9/25/2015
AP09/23/2015SLR44137055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s055lbl.pdf 10/6/2015
AP02/19/2016SLR45225056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf 2/23/2016
AP02/19/2016SLR45237056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018723s056lbl.pdf 2/23/2016




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