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FDA Drug Application 021168 by ABBVIE

Application Number021168
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
AP08/4/2000N1376000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21168ltr.pdf 8/4/2000
AP08/4/2000N1377000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21168lbl.pdf 8/4/2000
AP08/4/2000N7242000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-168_Depakote.cfm 12/15/2003
AP08/4/2000N19047000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm 2/1/2008
AP08/4/2000N35365000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM342868.pdf 3/8/2013
AP05/31/2002SCM1657001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21168s001ltr.pdf 5/31/2002
AP05/31/2002SCM1658001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21168s1lbl.pdf 5/31/2002
AP012/12/2002SLR8891003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116 6/2/2004
AP012/20/2002SLR8892004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20782,21168slr004ltr.pdf 6/2/2004
AP012/20/2002SLR4901004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20782_depakote_lbl.pdf 4/4/2003
AP012/20/2002SLR14433004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021168_S004_DepakoteTOC.cfm 7/10/2006
AP08/14/2003SE514434007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021168_S007_DepakoteTOC.cfm 7/10/2006
AP08/14/2003SE59383007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21168se5-007ltr.pdf 6/15/2004
AP08/14/2003SE59384007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21168se5-007_depakote_lbl.pdf 6/15/2004
AP04/20/2003SCS       
AP01/11/2006SLR13383009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf 1/13/2006
AP01/11/2006SLR13450009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021168s009ltr.pdf 1/20/2006
AP012/6/2005SE113238012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021168s012lbl.pdf 12/13/2005
AP012/6/2005SE113243012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021168s012ltr.pdf 12/13/2005
AP010/13/2006SLR15123014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf 10/18/2006
AP010/13/2006SLR15194014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf 10/23/2006
AP03/24/2008SE519531015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021168s015ltr.pdf 3/26/2008
AP03/24/2008SE519546015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021168s015lbl.pdf 3/27/2008
AP010/7/2011SLR30262016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf 10/12/2011
AP010/7/2011SLR30346016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf 10/19/2011
AP010/7/2011SLR30347017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf 10/19/2011
AP010/7/2011SLR30263017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf 10/12/2011
AP04/23/2009SLR22400018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021168s018ltr.pdf 5/4/2009
AP04/23/2009SLR22462018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021168s018lbl.pdf 5/7/2009
AP06/19/2014SLR39617019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf 6/23/2014
AP06/19/2014SLR39643019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s019lbl.pdf 6/23/2014
AP010/7/2011SLR30264020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf 10/12/2011
AP010/7/2011SLR30348020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf 10/19/2011
AP010/7/2011SLR30349022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021168s016,s017,s020,s022ltr.pdf 10/19/2011
AP010/7/2011SLR30265022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021168s016lbl.pdf 10/12/2011
AP02/27/2013SLR35287023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf 3/1/2013
AP02/27/2013SLR35315023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s023lbl.pdf 3/1/2013
AP07/31/2013SLR37148024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s024lbl.pdf 9/17/2013
AP07/31/2013SLR37149024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf 9/17/2013
AP06/14/2013SLR36415025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021168s025lbl.pdf 7/2/2013
AP011/20/2014SLR41079026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf 11/24/2014
AP011/20/2014SLR41151026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s026lbl.pdf 12/3/2014
AP01/7/2015SLR41527027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf 1/8/2015
AP01/7/2015SLR41539027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s027lbl.pdf 1/8/2015
AP06/9/2014SLR39471028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf 6/10/2014
AP06/9/2014SLR39513028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf 6/11/2014
AP08/20/2014SLR40295029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf 8/21/2014
AP08/20/2014SLR40303029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021168s029lbl.pdf 8/22/2014
AP03/20/2015SLR42534030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021168Orig1s030ltr.pdf 4/16/2015
AP03/20/2015SLR42598030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168Orig1s030lbl.pdf 4/21/2015
AP03/13/2015SLR42160031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf 3/17/2015
AP03/13/2015SLR42181031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s031lbl.pdf 3/17/2015
AP09/23/2015SLR43996032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf 9/25/2015
AP09/23/2015SLR44134032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021168s032lbl.pdf 10/6/2015
AP02/18/2016SLR45228033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf 2/23/2016
AP02/18/2016SLR45260033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021168s033lbl.pdf 2/24/2016
AP05/12/2016SCM       




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