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FDA Drug Application 019680 by ABBVIE

Application Number019680
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
AP09/12/1989N19045000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm 2/1/2008
AP09/12/1989N35364000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM342868.pdf 3/8/2013
AP01/14/1993SCS       
AP03/23/1995SCS       
AP06/20/1996SE1       
AP04/26/1996SLR       
AP012/2/1996SCS       
AP05/8/1998SCP       
AP06/19/2000SLR       
AP012/12/2002SLR8889015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116 6/2/2004
AP011/5/2002SCS       
AP01/11/2006SLR13385019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf 1/13/2006
AP01/11/2006SLR13449019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019680s019ltr.pdf 1/20/2006
AP012/19/2006SLR15492021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019680s021lbl.pdf 12/26/2006
AP012/19/2006SLR15531021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019680s021ltr.pdf 12/28/2006
AP010/13/2006SLR15121022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf 10/18/2006
AP010/13/2006SLR15195022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf 10/23/2006
AP03/24/2008SE5       
AP010/7/2011SLR30269025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf 10/12/2011
AP010/7/2011SLR30312025   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
AP04/23/2009SLR22380026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019680s026ltr.pdf 5/1/2009
AP04/23/2009SLR22463026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019680s026lbl.pdf 5/7/2009
AP010/7/2011SLR30313027   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
AP010/7/2011SLR30270027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf 10/12/2011
AP06/19/2014SLR39615028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf 6/23/2014
AP06/19/2014SLR39641028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s028lbl.pdf 6/23/2014
AP010/7/2011SLR30271029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf 10/12/2011
AP010/7/2011SLR30314029   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
AP010/7/2011SLR30315031   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
AP010/7/2011SLR30272031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019680s025lbl.pdf 10/12/2011
AP06/20/2014SLR39622033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019680Orig1s033ltr.pdf 6/23/2014
AP06/20/2014SLR39637033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s033lbl.pdf 6/23/2014
AP02/27/2013SLR35285034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf 3/1/2013
AP02/27/2013SLR35331034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s034lblupdated.pdf 3/4/2013
AP07/31/2013SLR37146035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s035lbl.pdf 9/17/2013
AP07/31/2013SLR37147035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf 9/17/2013
AP06/14/2013SLR36412036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019680s036lbl.pdf 7/2/2013
AP011/20/2014SLR41077037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf 11/24/2014
AP011/20/2014SLR41149037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s037lbl.pdf 12/3/2014
AP01/7/2015SLR41525038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf 1/8/2015
AP01/7/2015SLR41537038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s038lbl.pdf 1/8/2015
AP06/9/2014SLR39473039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf 6/10/2014
AP06/9/2014SLR39515039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf 6/11/2014
AP08/20/2014SLR40293040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf 8/21/2014
AP08/20/2014SLR40305040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019680s040lbl.pdf 8/22/2014
AP03/13/2015SLR42158041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf 3/17/2015
AP03/13/2015SLR42185041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018723s054,019680s041lbl.pdf 3/17/2015
AP09/23/2015SLR43994042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf 9/25/2015
AP09/23/2015SLR44136042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019680s042lbledt.pdf 10/6/2015
AP02/18/2016SLR45226043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf 2/23/2016
AP02/18/2016SLR45238043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019680s043lbl.pdf 2/23/2016




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