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FDA Drug Application 020945 by ABBVIE

Application Number020945
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
AP06/29/1999N8096000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945_Ritonovir.cfm 3/28/2004
AP06/29/1999N9280000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945.pdf_Ritonovir_Approv.pdf 6/10/2004
AP06/29/1999N9281000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-945.pdf_Ritonovir_Prntlbl.pdf 6/10/2004
AP010/21/1999SLR       
AP010/26/1999SLR       
AP012/23/1999SCE       
AP05/8/2000SLR       
AP08/21/2001SLR5468005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20945s5lbl.pdf 4/25/2003
AP02/5/2001SCE       
AP03/6/2001SLR3009007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20659s26ltr.pdf 3/6/2001
AP03/14/2002SLR3007008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20659s27ltr.pdf 3/14/2002
AP03/14/2002SLR3008008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20659S27lbl.pdf 3/14/2002
AP09/17/2002SCS       
AP09/30/2002SCE       
AP09/30/2002SCS       
AP012/24/2002SCS       
AP09/10/2003SLR6657013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20659slr030,20945slr013ltr.pdf 9/25/2003
AP09/10/2003SLR6688013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20659slr030,20945slr013_norvir_lbl.pdf 9/25/2003
AP03/28/2005SLR11320014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20659s032,20945s014ltr.pdf 3/30/2005
AP03/28/2005SLR11321014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20659s032,20945s014lbl.pdf 3/30/2005
AP011/9/2005SLR18512016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020945_S016_NORVIR.pdf 11/19/2007
AP011/9/2005SLR13068016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020945s016,020659s033lbl.pdf 11/17/2005
AP011/9/2005SLR13091016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020945s016,020659s033ltr.pdf 11/18/2005
AP010/6/2005SE518511017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020945_S017_NORVIR.pdf 11/19/2007
AP010/6/2005SE512852017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020659s034,020945s017lbl.pdf 10/10/2005
AP010/6/2005SE512862017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020659s034,020945s017ltr.pdf 10/11/2005
AP05/10/2007SLR16563018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s036,020945s018ltr.pdf 5/16/2007
AP05/10/2007SLR16573018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s036,020945s018lbl.pdf 5/16/2007
AP05/16/2008SLR19850019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s019ltr.pdf 5/20/2008
AP07/31/2007SLR17455020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020659s040,020945s020lbl.pdf 8/2/2007
AP07/31/2007SLR17467020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020659s040, 020945s020ltr.pdf 8/2/2007
AP08/29/2008SLR20725022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020945s022,020659s042lbl.pdf 8/29/2008
AP08/29/2008SLR20729022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020945s022, 020659s042ltr.pdf 9/3/2008
AP010/1/2008SLR20920023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020659s043, 020945s023ltr.pdf 10/2/2008
AP010/1/2008SLR23123023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020659s043,020945s023lbl.pdf 8/4/2009
AP011/23/2009SLR24171026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020945s026,020659s047lbl.pdf 12/2/2009
AP011/23/2009SLR24560026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020945s026,020659s047ltr.pdf 1/20/2010
AP04/27/2010SLR25385028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020945s028ltr.pdf 4/29/2010
AP04/27/2010SLR25512028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020945s028lbl.pdf 5/7/2010
AP012/6/2011SLR30897032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020945s032ltr.pdf 12/8/2011
AP012/6/2011SLR30996032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020945s032lbl.pdf 12/14/2011
AP03/29/2012SLR32313033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s033lbl.pdf 3/29/2012
AP03/29/2012SLR32327033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s033ltr.pdf 4/2/2012
AP02/17/2012SLR31861034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s034lbl.pdf 2/22/2012
AP02/17/2012SLR31874034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945s034ltr.pdf 2/23/2012
AP011/19/2012SLR34445035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020945Orig1s035ltr.pdf 11/21/2012
AP011/19/2012SLR34491035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020945s035lbl.pdf 11/28/2012
AP011/7/2013SLR37749036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020945Orig1s036ltr.pdf 11/8/2013
AP011/7/2013SLR37770036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020945s036lbl.pdf 11/8/2013
AP03/16/2015SLR42187038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s038lbl.pdf 3/17/2015
AP03/16/2015SLR42190038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s038ltr.pdf 3/18/2015
AP03/27/2015SLR42340039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s039ltr.pdf 4/1/2015
AP03/27/2015SLR42405039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s039lbl.pdf 4/2/2015
AP011/10/2015SLR44454040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020945s040lbl.pdf 11/12/2015
AP011/10/2015SLR44463040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020945Orig1s040ltr.pdf 11/13/2015
AP09/15/2016SLR47079043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020945Orig1s043ltr.pdf 9/20/2016
AP09/15/2016SLR47121043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020945s043lbl.pdf 9/20/2016




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