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FDA Drug Application 050698 by ABBVIE

Application Number050698
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
AP212/23/1993N14982000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm084280.htm 9/25/2006
AP07/17/1996SE1       
AP08/12/1994SE1       
AP08/12/1994SE1       
AP08/12/1994SE1       
AP03/24/1994SCS       
AP010/23/1995SCF       
AP08/26/1997SLR       
AP010/3/1997SCS       
AP09/30/1998SCS       
AP06/5/2000SLR       
AP05/24/2002SE74413014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50697s002ltr.pdf 5/24/2002
AP011/21/2002SCS       
AP07/19/2004SLR9751019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50662s036,50697s003,50698s019,50775s007ltr.pdf 7/21/2004
AP010/4/2005SLR12845020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050662s038,050698s020,050775s008lbl.pdf 10/10/2005
AP010/4/2005SLR12913020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050662s038,050698s020,050775s008ltr.pdf 10/20/2005
AP07/5/2006SLR14456021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050662s039, 050698s021, 050775s009LTR.pdf 7/13/2006
AP012/18/2007SLR18682022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050662s040,050698s022,050775s011lbl.pdf 12/27/2007
AP012/18/2007SLR18818022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050662s040, 050698s022, 050775s011ltr.pdf 1/9/2008
AP05/21/2008SLR19896023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050662s041,050698s023,050775s012ltr.pdf 5/29/2008
AP08/14/2009SLR23442024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050662s042,050698s024,050775s013lbl.pdf 9/22/2009
AP08/14/2009SLR24063024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050662s042,050698s024,050775s013ltr.pdf 11/20/2009
AP05/27/2011SLR29000025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf 5/31/2011
AP05/27/2011SLR29006025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf 5/31/2011
AP05/3/2012SLR32631026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf 5/7/2012
AP05/3/2012SLR32669026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf 5/9/2012
AP05/27/2011SLR29001027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050662s043,s045,050698s025,s027,050775s014,s016ltr.pdf 5/31/2011
AP05/27/2011SLR29007027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050662s043s045,050698s025s027,050775s014s016lbl.pdf 5/31/2011
AP06/1/2012SLR32810028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s046,050698s028,050775s017lltr.pdf 6/5/2012
AP07/5/2012SLR33103029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s048,050698s029,050775s018ltr.pdf 7/10/2012
AP07/5/2012SLR33109029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s048,050698s029,050775s018lbl.pdf 7/10/2012
AP05/3/2012SLR32632030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050662s044s050,50698s026s030,050775s015s019lbl.pdf 5/7/2012
AP05/3/2012SLR32670030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050662s044,s050,050698s026,s030,050775s015,s019ltr.pdf 5/9/2012
AP09/9/2013SLR37029031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050698s031lbl.pdf 9/9/2013
AP09/9/2013SLR37051031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 9/11/2013
AP09/9/2013SLR37030032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050698s032lbl.pdf 9/9/2013
AP09/9/2013SLR37052032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050662Orig1s052,s053,050698Orig1s031,s032,050775Orig1s020,s021ltr.pdf 9/11/2013
AP05/26/2016SLR46192033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050662Orig1s054,050698Orig1s033,050775Orig1s022ltr.pdf 5/31/2016
AP05/26/2016SLR46219033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050662s054,050698s033,050775s002lbl.pdf 6/1/2016
AP010/24/2013SCM       
AP07/25/2014SLR40023035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023ltr.pdf 7/28/2014
AP07/25/2014SLR40173035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050662Orig1s055,050698Orig1s035,050775Orig1s023lbl.pdf 8/7/2014
AP01/8/2015SLR41566036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s056,050698Orig1s036,050775Orig1s024ltr.pdf 1/9/2015
AP01/8/2015SLR41616036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s056lbl.pdf 1/12/2015
AP010/23/2015SLR44318037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050662Orig1s057,050698Orig1s037,050775Orig1s025ltr.pdf 10/28/2015
AP010/23/2015SLR44334037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050662s057,050698s037,050775s025lbl.pdf 10/29/2015




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