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FDA Drug Application 020659 by ABBVIE

Application Number020659
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/1/1996N       
AP010/1/1996SCS       
AP010/1/1996SCS       
AP09/24/1996SLR       
AP01/8/1997SLR       
AP09/17/1997SCS       
AP05/9/1997SCM       
AP03/14/1997SE2       
AP010/31/1997SLR       
AP01/23/1998SCM       
AP05/1/1998SCM       
AP02/12/1998SLR       
AP05/26/1999SE711482013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020659s013_020680s011_Norvir.cfm 4/27/2005
AP07/24/1998SCS       
AP09/25/1998SCM       
AP010/30/1998SLR       
AP02/26/1999SCS       
AP04/12/1999SLR       
AP04/9/1999SLR       
AP010/28/1999SCS       
AP010/21/1999SLR       
AP010/26/1999SLR       
AP05/8/2000SLR       
AP09/1/2000SCM       
AP08/21/2001SLR5469025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf 4/25/2003
AP03/6/2001SLR1614026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20659s26ltr.pdf 3/6/2001
AP03/14/2002SLR3005027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20659s27ltr.pdf 3/14/2002
AP03/14/2002SLR3006027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20659S27lbl.pdf 3/14/2002
AP012/24/2002SCS       
AP09/10/2003SLR6656030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20659slr030,20945slr013ltr.pdf 9/25/2003
AP09/10/2003SLR6687030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf 9/25/2003
AP03/28/2005SLR11318032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20659s032,20945s014ltr.pdf 3/30/2005
AP03/28/2005SLR11319032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20659s032,20945s014lbl.pdf 3/30/2005
AP011/9/2005SLR13069033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020945s016,020659s033lbl.pdf 11/17/2005
AP011/9/2005SLR13090033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020945s016,020659s033ltr.pdf 11/18/2005
AP011/9/2005SLR18531033   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020659_S033_NORVIR.pdf 11/19/2007
AP010/6/2005SE512853034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf 10/10/2005
AP010/6/2005SE512863034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020659s034,020945s017ltr.pdf 10/11/2005
AP010/6/2005SE518530034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020659_S034_NORVIR.pdf 11/19/2007
AP05/10/2007SLR16564036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s036,020945s018ltr.pdf 5/16/2007
AP05/10/2007SLR16574036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s036,020945s018lbl.pdf 5/16/2007
AP05/16/2008SLR19849039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s039ltr.pdf 5/20/2008
AP07/31/2007SLR17456040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s040,020945s020lbl.pdf 8/2/2007
AP07/31/2007SLR17468040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s040, 020945s020ltr.pdf 8/2/2007
AP08/29/2008SLR20726042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf 8/29/2008
AP08/29/2008SLR20730042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s022, 020659s042ltr.pdf 9/3/2008
AP010/1/2008SLR20919043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s043, 020945s023ltr.pdf 10/2/2008
AP010/1/2008SLR23124043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf 8/4/2009
AP02/10/2010SLR24768045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s045lbl.pdf 2/16/2010
AP02/10/2010SLR24795045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s045ltr.pdf 2/17/2010
AP011/23/2009SLR24172047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020945s026,020659s047lbl.pdf 12/2/2009
AP011/23/2009SLR24561047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020945s026,020659s047ltr.pdf 1/20/2010
AP04/27/2010SLR25442050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020659s050,022417s001ltr.pdf 5/3/2010
AP04/27/2010SLR25506050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020659s050,022417s001lbl.pdf 5/7/2010
AP012/6/2011SLR30898055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020659s055,022417s006ltr.pdf 12/8/2011
AP012/6/2011SLR30995055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020659s055,022417s006lbl.pdf 12/14/2011
AP02/17/2012SLR31863056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020659s056,022417s007lbl.pdf 2/22/2012
AP02/17/2012SLR31890056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020659s056,022417s007ltr.pdf 2/27/2012
AP011/20/2012SLR34450057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022417Orig1s008,020659Orig1s057ltr.pdf 11/23/2012
AP011/20/2012SLR34487057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022417s008,020659s057lbl.pdf 11/28/2012
AP011/7/2013SLR37746058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020659Orig1s058,022417Orig1s010ltr.pdf 11/8/2013
AP011/7/2013SLR37774058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020659s058_022417s010lbl.pdf 11/8/2013
AP03/16/2015SLR42164060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s012,020659Orig1s060ltr.pdf 3/17/2015
AP03/16/2015SLR42195060   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s060,022417s012lbl.pdf 3/19/2015
AP03/27/2015SLR42411061   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022417Orig1s013,020659Orig1s061ltr.pdf 4/3/2015
AP03/27/2015SLR42462061   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022417s013,020659s061lbl.pdf 4/7/2015
AP011/10/2015SLR44456062   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020659s062,022417s014lbl.pdf 11/12/2015
AP011/10/2015SLR44487062   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020659Orig1s062,022417Orig1s14ltr.pdf 11/17/2015
AP011/10/2015SLR45371062SLC  http://www.fda.gov/cder/ 3/4/2016
AP09/15/2016SLR47076065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022417s017,020659Orig1s065ltr.pdf 9/19/2016
AP09/15/2016SLR47112065   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020659s065,022417s017lbl.pdf 9/20/2016




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