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FDA Drug Application 020593 by ABBVIE

Application Number020593
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
AP012/30/1996N19041000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm192645.htm 2/1/2008
AP012/16/1997SCS       
AP06/19/2000SLR       
AP012/8/1999SCS       
AP05/15/2000SCS       
AP06/20/2000SCS       
AP01/24/2002SE219232006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020593_S006_DEPACON.pdf 2/19/2008
AP01/24/2002SE21655006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20593s006ltr.pdf 1/24/2002
AP01/24/2002SE21656006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20593s006lbl.pdf 1/24/2002
AP06/26/2002SCS       
AP08/12/2002SCS       
AP012/12/2002SLR8890009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18081slr038,18082s024,18723s024,19680s015,20593s009,2116 6/2/2004
AP01/11/2006SLR13384011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018081s42,18082s26,18723s32,19680s19,20593s11,21168s9lbl.pdf 1/13/2006
AP01/11/2006SLR13446011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020593s011ltr.pdf 1/20/2006
AP010/13/2006SLR15122015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/18081s44,18082s27,18723s33,19680s22,20593s15,21168s14lbl.pdf 10/18/2006
AP010/13/2006SLR15197015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018081s44_82s27,20593s15,18723s33,19680s22,21168s14.pdf 10/23/2006
AP010/7/2011SLR31290016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020593s016s020s023lbl.pdf 10/7/2011
AP010/7/2011SLR30316016   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
AP06/19/2014SLR39616019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s049,018082Orig1s034,018723Orig1s041,019680Orig1s028,020593Orig1s019,021168Orig1s019ltr.pdf 6/23/2014
AP06/19/2014SLR39638019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020593s019lbl.pdf 6/23/2014
AP010/7/2011SLR30317020   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
AP010/7/2011SLR30267020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020593s016s020s023lbl.pdf 10/12/2011
AP010/7/2011SLR30268023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020593s016s020s023lbl.pdf 10/7/2011
AP010/7/2011SLR30318023   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
AP02/27/2013SLR35286025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081s054,018082s038,018723s047,019680s034,020593s025,021168s023_replace_ltr.pdf 3/1/2013
AP02/27/2013SLR35327025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020593s025lbl.pdf 3/4/2013
AP07/31/2013SLR37150026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020593s026lbl.pdf 9/17/2013
AP07/31/2013SLR37151026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018081Orig1s057,018082Orig1s040,018723Orig1s049,019680Orig1s036,020593Orig1s027,021168Orig1s025ltr.pdf 9/17/2013
AP06/14/2013SLR36418027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020593s027lbl.pdf 7/2/2013
AP011/20/2014SLR41078028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s058,018082Orig1s041,018723Orig1s050,019680Orig1s037,020593Orig1s028,021168Orig1s026ltr.pdf 11/24/2014
AP011/20/2014SLR41150028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020593s028lbl.pdf 12/3/2014
AP01/7/2015SLR41526029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s059,0108082Orig1s042,018723Origs051,019680Orig1s038,020593Orig1s029,021168Orig1s027ltr.pdf 1/8/2015
AP01/7/2015SLR41538029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020593s029lbl.pdf 1/8/2015
AP06/9/2014SLR39472030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018081s060,018082s043,018723s052,019680s039,020593s030,021168s028lbl.pdf 6/10/2014
AP06/9/2014SLR39518030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021168Orig1s028,018081Orig1s060,019680Orig1s039,018082Orig1s043,018723Orig1s052,020593Orig1s030ltr.pdf 6/11/2014
AP08/20/2014SLR40294031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018081Orig1s061,018082Orig1s044,018723Orig1s053,019680Orig1s040,020593Orig1s031,021168Orig1s029ltr.pdf 8/21/2014
AP08/20/2014SLR40304031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020593s031lbl.pdf 8/22/2014
AP03/13/2015SLR42159032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s062,018082Orig1s045,018723Orig1s054,019680Orig1s041,020593Orig1s032,021168Orig1s031ltr.pdf 3/17/2015
AP03/13/2015SLR42182032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020593s032lbl.pdf 3/17/2015
AP09/23/2015SLR43995033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018081Orig1s063,018082Orig1s046,018723Orig1s055,019680Orig1s042,020593Orig1s033,021168Orig1s032ltr.pdf 9/25/2015
AP09/23/2015SLR44135033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020593s033lbl.pdf 10/6/2015
AP02/18/2016SLR45227034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018081Orig1s064,018082Orig1s047,018723Orig1s056,019680Orig1s043,020593Orig1s034,021168Orig1s033ltr.pdf 2/23/2016
AP02/18/2016SLR45239034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020593s034lbl.pdf 2/23/2016




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