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FDA Drug Application 018082 by ABBVIE

Application Number018082
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative; New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/28/1978N19049000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm 2/1/2008
AP02/28/1978N35367000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM342868.pdf 3/8/2013
AP05/3/1979SLR       
AP012/20/1979SCS       
AP09/29/1980SCE       
AP012/9/1981SLR       
AP011/4/1981SLR       
AP09/30/1982SCP       
AP012/4/1985SLR       
AP08/11/1986SLR       
AP03/23/1995SCS       
AP012/2/1996SCS       
AP05/16/2000SLR       
AP06/19/2000SLR       
AP012/12/2002SLR8887024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116 6/2/2004
AP01/11/2006SLR13387026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf 1/13/2006
AP01/11/2006SLR13447026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018082s026ltr.pdf 1/20/2006
AP010/13/2006SLR15119027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf 10/18/2006
AP010/13/2006SLR15199027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf 10/23/2006
AP010/7/2011SLR30282031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf 10/12/2011
AP010/7/2011SLR30303031   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
AP04/23/2009SLR22378032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/018081s047,018082s032ltr.pdf 5/1/2009
AP04/23/2009SLR22522032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018081s047,018082s032lbl.pdf 5/12/2009
AP010/7/2011SLR30304033   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
AP010/7/2011SLR30283033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf 10/12/2011
AP06/19/2014SLR39613034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf 6/23/2014
AP06/19/2014SLR39640034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s049,018082s034lbl.pdf 6/23/2014
AP010/7/2011SLR30284035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf 10/12/2011
AP010/7/2011SLR30305035   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
AP010/7/2011SLR30306037   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
AP010/7/2011SLR30285037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018081s046_18082s031lbl.pdf 10/12/2011
AP02/27/2013SLR35283038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf 3/1/2013
AP02/27/2013SLR35328038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s054,018082s038lbl.pdf 3/4/2013
AP07/31/2013SLR37144039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081S056lbl.pdf 9/17/2013
AP07/31/2013SLR37145039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf 9/17/2013
AP06/14/2013SLR36417040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018081s057,018082s040lbl.pdf 7/2/2013
AP011/20/2014SLR41075041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf 11/24/2014
AP011/20/2014SLR41147041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s058,018082s041lbl.pdf 12/3/2014
AP01/7/2015SLR41523042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf 1/8/2015
AP01/7/2015SLR41535042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s059,018082s042lbl.pdf 1/8/2015
AP06/9/2014SLR39475043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf 6/10/2014
AP06/9/2014SLR39516043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf 6/11/2014
AP08/20/2014SLR40291044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf 8/21/2014
AP08/20/2014SLR40307044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s061,018082s044lbl.pdf 8/22/2014
AP03/13/2015SLR42156045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf 3/17/2015
AP03/13/2015SLR42184045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s062,018082s045lbl.pdf 3/17/2015
AP09/23/2015SLR43992046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf 9/25/2015
AP09/23/2015SLR44138046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018081s063,018082s046lbl.pdf 10/6/2015
AP02/18/2016SLR45224047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf 2/23/2016
AP02/18/2016SLR45235047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018081s064,018082s047lbl.pdf 2/23/2016




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