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FDA Drug Application 021015 by ABBVIE

Application Number021015
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/28/2000N901000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21015ltr.pdf 2/28/2000
AP02/28/2000N902000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21015lbl.pdf 2/28/2000
AP02/28/2000N7570000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-015_AndroGel.cfm 1/15/2004
AP02/28/2000N23707000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM188474.pdf 10/30/2009
AP02/28/2000N28442000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=4 4/4/2011
AP06/7/2000SLR       
AP01/23/2001SCE       
AP09/5/2001SLR       
AP010/22/2002SLR4451004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21015slr004ltr.pdf 10/22/2002
AP010/22/2002SLR4452004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21015s4lbl.pdf 10/22/2002
AP06/27/2001SLR       
AP08/9/2001SCM       
AP09/18/2002SCS       
AP09/17/2003SLR6706008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21015slr008ltr.pdf 9/29/2003
AP09/17/2003SLR14201008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021015_s008_AndrogelTOC.cfm 6/1/2006
AP09/26/2003SCP6713010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21015scp010ltr.pdf 9/30/2003
AP09/26/2003SCP14200010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021015_s010_AndrogelTOC.cfm 6/1/2006
AP08/11/2005SE812612011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021015s011ltr.pdf 8/16/2005
AP011/19/2004SLR10679012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21015s012ltr.pdf 12/2/2004
AP011/19/2004SLR10714012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21015s012lbl.pdf 12/3/2004
AP08/16/2005SLR12627013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021015s013ltr.pdf 8/19/2005
AP08/16/2005SLR12646013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021015s013lbl.pdf 8/19/2005
AP012/13/2007SLR18649016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s016lbl.pdf 12/14/2007
AP012/13/2007SLR18837016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s016ltr.pdf 1/9/2008
AP012/27/2007SLR18726019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf 1/8/2008
AP012/27/2007SLR18756019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s019,s020ltr.pdf 1/9/2008
AP012/27/2007SLR18727020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021015s019s020lbl.pdf 1/8/2008
AP012/27/2007SLR18757020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021015s019,s020ltr.pdf 1/9/2008
AP09/18/2009SLR23512022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021015s022lbl.pdf 10/1/2009
AP09/18/2009SLR23679022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021015s022ltr.pdf 10/26/2009
AP03/10/2011SLR28223028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s028lbl.pdf 3/11/2011
AP03/10/2011SLR28234028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021015s028ltr.pdf 3/14/2011
AP011/30/2011SLR30868032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021015s032lbl.pdf 12/2/2011
AP011/30/2011SLR30875032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021015s032ltr.pdf 12/5/2011
AP011/19/2012SCM       
AP09/20/2012SLR33823034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021015Orig1s034ltr.pdf 9/24/2012
AP09/20/2012SLR33832034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021015Orig1s034lbledt.pdf 9/24/2012
AP05/20/2013SLR36120036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021015Orig1s036ltr.pdf 5/22/2013
AP05/20/2013SLR36123036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021015s036lbl.pdf 5/20/2013
AP02/27/2014SCM       
AP011/12/2014SLR40988038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021015Orig1s038ltr.pdf 11/14/2014
AP011/12/2014SLR41312038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015Orig1s038lbl.pdf 12/18/2014
AP06/19/2014SLR39604039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021015Orig1s039ltr.pdf 6/23/2014
AP06/19/2014SLR39634039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021015s039lbl.pdf 6/23/2014
AP05/11/2015SLR42794040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021015Orig1s040ltr.pdf 5/13/2015
AP05/11/2015SLR42805040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021015s040lbl.pdf 5/13/2015
AP08/17/2015SCM       
AP010/17/2016SCM       
AP010/25/2016SLR47474043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021015Orig1s043ltr.pdf 10/27/2016




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