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FDA Drug Application 021226 by ABBVIE

Application Number021226
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/15/2000N1465000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21226ltr.pdf 9/15/2000
AP09/15/2000N1466000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21226lbl.pdf 9/15/2000
AP09/15/2000N1981000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-226_Kaletra.cfm 9/15/2000
AP09/15/2000N4730000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21226ppi.pdf 9/15/2000
AP09/15/2000N33060000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143461.pdf 6/29/2012
AP01/30/2001SLR       
AP03/13/2001SLR1613002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21251s2ltr.pdf 3/13/2001
AP03/13/2001SLR1976002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra_prntlbl.pdf 3/13/2001
AP03/13/2001SLR1977002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-251S002_Kaletra.cfm 3/13/2001
AP01/18/2002SE81962003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21226s3ltr.pdf 1/18/2002
AP01/18/2002SE81971003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226s3lbl.pdf 1/18/2002
AP01/18/2002SE81972003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-251S003_Kaletra.cfm 1/18/2002
AP01/18/2002SE8       
AP02/13/2002SCS       
AP011/27/2002SE71942006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21226se7-006,21251se7-005_Kaletra_lbl.pdf 11/27/2002
AP011/27/2002SE718083006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021226_S006_KALETRA.pdf 9/26/2007
AP012/24/2002SCS       
AP012/3/2003SLR7058012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21226slr012,21251slr009ltr.pdf 12/8/2003
AP012/3/2003SLR7069012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21226slr012,21251slr009_kaletra_lbl.pdf 12/8/2003
AP010/19/2004SE810458014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21226s014,21251s010ltr.pdf 10/26/2004
AP010/19/2004SE810465014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21226s014,21251s010lbl.pdf 10/26/2004
AP010/19/2004SE818082014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021226_S014_KALETRA.pdf 9/26/2007
AP04/29/2005SE211568016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021226s016ltr.pdf 5/3/2005
AP04/29/2005SE211574016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s016lbl.pdf 5/3/2005
AP03/28/2005SLR11328017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021226s017,021251s011ltr.pdf 3/30/2005
AP03/28/2005SLR11329017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021226s017,021251s011lbl.pdf 3/30/2005
AP03/28/2005SLR18081017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021226_S017_KALETRA.pdf 9/26/2007
AP04/20/2007SE816299018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s018lbl.pdf 4/25/2007
AP04/20/2007SE816310018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s018_LTR.pdf 4/25/2007
AP012/21/2006SLR15513019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021226s019lbl.pdf 12/28/2006
AP012/21/2006SLR15594019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021226s019ltr.pdf 1/8/2007
AP07/9/2007SLR17269020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s020lbl.pdf 7/10/2007
AP07/9/2007SLR17278020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s020ltr.pdf 7/16/2007
AP09/26/2007SLR18045022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021226s022lbl.pdf 9/26/2007
AP09/26/2007SLR18138022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021226s022ltr.pdf 10/4/2007
AP04/27/2010SLR25509030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021226s030lbl.pdf 5/7/2010
AP04/27/2010SLR25721030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021226s030ltr.pdf 6/9/2010
AP02/17/2012SLR31856035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s035lbl.pdf 2/22/2012
AP02/17/2012SLR31896035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021226s035ltr.pdf 2/27/2012
AP06/27/2012SLR33041036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021226s036ltr.pdf 6/28/2012
AP06/27/2012SLR33049036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021226s036lbl.pdf 6/28/2012
AP01/17/2013SLR34900037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021226Orig1s037ltr.pdf 1/22/2013
AP01/17/2013SLR34923037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s037lbl.pdf 1/22/2013
AP011/7/2013SLR37753038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021226Orig1s038ltr.pdf 11/8/2013
AP011/7/2013SLR37777038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021226s038lbl.pdf 11/8/2013
AP06/26/2015SE843172040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s040lbl.pdf 7/1/2015
AP06/26/2015SE843227040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s040ltr.pdf 7/6/2015
AP03/27/2015SLR42343041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s041ltr.pdf 4/1/2015
AP03/27/2015SLR42398041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s041lbl.pdf 4/2/2015
AP011/10/2015SLR44459042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021226s042lbl.pdf 11/12/2015
AP011/10/2015SLR44464042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021226Orig1s042ltr.pdf 11/13/2015
AP09/15/2016SLR47092044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021226Orig1s044ltr.pdf 9/20/2016
AP09/15/2016SLR47158044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021226s044lbl.pdf 9/23/2016




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