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FDA Drug Application 021251 by ABBVIE

Application Number021251
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation; New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/15/2000N1529000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21251ltr.pdf 9/15/2000
AP09/15/2000N1530000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21251lbl.pdf 9/15/2000
AP09/15/2000N1941000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-226_Kaletra.cfm 9/15/2000
AP09/15/2000N4729000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21251ppi.pdf 9/15/2000
AP09/15/2000N24000000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM310187.pdf 11/19/2009
AP01/30/2001SLR       
AP03/13/2001SLR1978002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21251s2ltr.pdf 3/13/2001
AP03/13/2001SLR1979002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra_prntlbl.pdf 3/13/2001
AP03/13/2001SLR1980002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra.cfm 3/13/2001
AP01/18/2002SE8       
AP01/18/2002SE81973004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21226s3ltr.pdf 1/18/2002
AP01/18/2002SE81974004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226s3lbl.pdf 1/18/2002
AP01/18/2002SE81975004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-251S003_Kaletra.cfm 1/18/2002
AP011/27/2002SE71961005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226se7-006,21251se7-005_Kaletra_lbl.pdf 11/27/2002
AP011/27/2002SE718079005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021251_S005_KALETRA.pdf 9/26/2007
AP012/24/2002SCS       
AP012/3/2003SLR7059009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21226slr012,21251slr009ltr.pdf 12/8/2003
AP012/3/2003SLR7070009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21226slr012,21251slr009_kaletra_lbl.pdf 12/8/2003
AP010/19/2004SE810459010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21226s014,21251s010ltr.pdf 10/26/2004
AP010/19/2004SE810466010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21226s014,21251s010lbl.pdf 10/26/2004
AP010/19/2004SE818078010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021251_S010_KALETRA.pdf 9/26/2007
AP03/28/2005SLR11330011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021226s017,021251s011ltr.pdf 3/30/2005
AP03/28/2005SLR11331011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s017,021251s011lbl.pdf 3/30/2005
AP04/20/2007SE816301012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s012,021906s002lbl.pdf 4/25/2007
AP04/20/2007SE816309012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s012, 021906s002_LTR.pdf 4/25/2007
AP012/21/2006SLR15514013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021906s003,021251s013lbl.pdf 12/28/2006
AP012/21/2006SLR15588013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021906s003, 21251s013ltr.pdf 1/8/2007
AP03/2/2007SLR15970014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s014, 021906s004ltr.pdf 3/7/2007
AP03/2/2007SLR15986014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s014,021906s004lbl.pdf 3/7/2007
AP06/29/2007SLR16878016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s016,021906s00533ltr.pdf 7/5/2007
AP06/29/2007SLR16951016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s016,021906s005lbl.pdf 7/5/2007
AP07/30/2008SLR20501017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s017ltr.pdf 8/5/2008
AP011/9/2007SE218422018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021251s018,021906s007lbl.pdf 11/19/2007
AP011/9/2007SE218460018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021251s018, 021906s007ltr.pdf 11/19/2007
AP09/25/2007SLR18033019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021906s008,021251s019lbl.pdf 9/26/2007
AP09/25/2007SLR18150019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021906s008, 021251s019ltr.pdf 10/4/2007
AP06/20/2008SE520068022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021251s022, 021906s013ltr.pdf 6/24/2008
AP06/20/2008SE520085022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021251s022,021906s013lbl.pdf 6/26/2008
AP04/6/2009SLR22229023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s014,021251s023ltr.pdf 4/10/2009
AP04/6/2009SLR22274023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s023,021906s014lbl.pdf 4/16/2009
AP010/3/2008SLR20974024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021906s015, 021251s024ltr.pdf 10/8/2008
AP010/3/2008SLR21008024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021906s015,021251s024lbl.pdf 10/9/2008
AP04/20/2009SE822311026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021251s026,021906s017lbl.pdf 4/23/2009
AP04/20/2009SE822320026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021906s017,021251s026ltr.pdf 4/24/2009
AP01/29/2010SLR24704029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s029,021906s022lbl.pdf 2/4/2010
AP01/29/2010SLR24739029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s029,021906s022ltr.pdf 2/5/2010
AP04/27/2010SE525447031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021906s024,021251s031ltr.pdf 5/3/2010
AP04/27/2010SE525510031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021906s024,021251s031lbl.pdf 5/7/2010
AP06/14/2010SLR25740033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021251s033lbl.pdf 6/15/2010
AP06/14/2010SLR25749033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021251s033,021906s026ltr.pdf 6/16/2010
AP02/24/2011SLR27989039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s039,021906s032ltr.pdf 3/1/2011
AP02/24/2011SLR28049039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021251s039,021906s032lbl.pdf 3/4/2011
AP05/6/2011SLR28777040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021251s040,21906s033ltr.pdf 5/10/2011
AP04/20/2012SLR32509041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034mg.pdf 4/24/2012
AP04/20/2012SLR32510041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s041,021906s034lbl.pdf 4/24/2012
AP04/20/2012SLR32530041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s034,021251s041ltr.pdf 4/24/2012
AP02/17/2012SLR31858042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021251s042,021906s035lbl.pdf 2/22/2012
AP02/17/2012SLR31894042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021251s042,021906s035ltr.pdf 2/27/2012
AP05/16/2012SLR32703044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044mg.pdf 5/17/2012
AP05/16/2012SLR32704044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021906s036,021251s044lbl.pdf 5/17/2012
AP05/16/2012SLR32713044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021906s036,021251s044ltr.pdf 5/18/2012
AP01/17/2013SLR34902045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s038,021251Orig1s045ltr.pdf 1/22/2013
AP01/17/2013SLR34925045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s045,021906s038lbl.pdf 1/22/2013
AP011/7/2013SLR37764046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021906Orig1s039,021251Orig1s046ltr.pdf 11/8/2013
AP011/7/2013SLR37778046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021251s046_021906s039lbl.pdf 11/8/2013
AP01/28/2015SE841717047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s040,021251Orig1s047ltr.pdf 1/29/2015
AP01/28/2015SE841745047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s047,021906s040lbl.pdf 1/30/2015
AP06/26/2015SE843176049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021906s042,021251s049lbl.pdf 7/1/2015
AP06/26/2015SE843250049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021906Orig1s042,021251Orig1s049ltr.pdf 7/6/2015
AP03/27/2015SLR42345050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s050,021906Orig1s043ltr.pdf 4/1/2015
AP03/27/2015SLR42404050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s050,021906s043lbl.pdf 4/2/2015
AP011/10/2015SLR44458051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021251s051,021906s044lbl.pdf 11/12/2015
AP011/10/2015SLR44489051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021251Orig1s051,021906Orig1s044ltr.pdf 11/17/2015
AP09/15/2016SLR47080053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021251Orig1s053,021906Orig1s047ltr.pdf 9/20/2016
AP09/15/2016SLR47124053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021251s053,021906s047lbl.pdf 9/20/2016




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