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FDA Drug Application 018081 by ABBVIE

Application Number018081
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/28/1978N19048000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm 2/1/2008
AP02/28/1978N35366000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM342868.pdf 3/8/2013
AP05/3/1979SLR       
AP012/20/1979SCS       
AP012/20/1979SCF       
AP06/16/1980SCE       
AP012/9/1981SLR       
AP011/4/1981SLR       
AP012/9/1981SLR       
AP09/30/1982SCE       
AP010/28/1983SCM       
AP05/30/1986SLR       
AP012/4/1985SLR       
AP05/30/1986SLR       
AP08/11/1986SLR       
AP012/2/1987SCM       
AP03/21/1989SCM       
AP03/23/1995SCS       
AP012/2/1996SCS       
AP05/16/2000SLR       
AP05/8/1998SCP       
AP09/22/1998SCM       
AP06/19/2000SLR       
AP012/6/1999SCS       
AP06/20/2000SCS       
AP012/20/2000SCM       
AP06/20/2000SCS       
AP012/12/2002SLR8886038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116 6/2/2004
AP01/11/2006SLR13388042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf 1/13/2006
AP01/11/2006SLR13445042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s042ltr.pdf 1/20/2006
AP010/13/2006SLR15118044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf 10/18/2006
AP010/13/2006SLR15198044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf 10/23/2006
AP010/7/2011SLR30278046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf 10/12/2011
AP010/7/2011SLR30299046   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
AP04/23/2009SLR22377047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018081s047,018082s032ltr.pdf 5/1/2009
AP010/7/2011SLR30300048   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
AP010/7/2011SLR30279048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf 10/12/2011
AP06/19/2014SLR39612049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf 6/23/2014
AP06/19/2014SLR39639049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s049,018082s034lbl.pdf 6/23/2014
AP010/7/2011SLR30280050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf 10/12/2011
AP010/7/2011SLR30301050   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
AP010/7/2011SLR30302052   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
AP010/7/2011SLR30281052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf 10/12/2011
AP02/27/2013SLR35282054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf 3/1/2013
AP02/27/2013SLR35329054   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s054,018082s038lbl.pdf 3/4/2013
AP07/31/2013SLR37142056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s056lbl.pdf 9/17/2013
AP07/31/2013SLR37143056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf 9/17/2013
AP06/14/2013SLR36416057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s057,018082s040lbl.pdf 7/2/2013
AP011/20/2014SLR41074058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf 11/24/2014
AP011/20/2014SLR41146058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s058,018082s041lbl.pdf 12/3/2014
AP01/7/2015SLR41522059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf 1/8/2015
AP01/7/2015SLR41534059   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s059,018082s042lbl.pdf 1/8/2015
AP06/9/2014SLR39476060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf 6/10/2014
AP06/9/2014SLR39514060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf 6/11/2014
AP08/20/2014SLR40290061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf 8/21/2014
AP08/20/2014SLR40308061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s061,018082s044lbl.pdf 8/22/2014
AP03/13/2015SLR42155062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf 3/17/2015
AP03/13/2015SLR42183062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s062,018082s045lbl.pdf 3/17/2015
AP09/23/2015SLR43991063   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf 9/25/2015
AP09/23/2015SLR44139063   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s063,018082s046lbl.pdf 10/6/2015
AP02/18/2016SLR45223064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf 2/23/2016
AP02/18/2016SLR45236064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s064,018082s047lbl.pdf 2/23/2016




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