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FDA Drug Application 020933 by BOEHRINGER INGELHEIM

Application Number020933
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
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
AP09/11/1998N7685000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_20-636S009_Viramune.cfm 2/9/2004
AP09/11/1998N9631000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Approv.pdf 6/30/2004
AP09/11/1998N9632000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Prntlbl.pdf 6/30/2004
AP09/11/1998N15875000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089818.pdf 2/22/2007
AP010/25/1999SLR       
AP08/10/2000SLR       
AP011/6/2000SLR       
AP05/17/2001SCP       
AP02/23/2001SCS       
AP012/31/2002SLR9630006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636slr016,20933slr006ltr.pdf 6/30/2004
AP012/31/2002SLR4895006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20636slr016,20933slr006_viramune_lbl.pdf 4/4/2003
AP03/27/2002SE72794007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636s17ltr.pdf 3/27/2002
AP03/27/2002SE711469007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020636s017_020933s007_Viramune.cfm 4/27/2005
AP012/20/2002SCS       
AP07/29/2003SLR9629010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr020,20933slr010ltr.pdf 6/30/2004
AP07/29/2003SLR6407010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr020,20933slr010_viramune_lbl.pdf 8/6/2003
AP012/22/2003SLR7352011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr021,20933slr011ltr.pdf 12/23/2003
AP012/22/2003SLR7431011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr021,20933slr011_viramune_lbl.pdf 12/29/2003
AP05/24/2004SLR       
AP02/24/2005SLR17404014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020933_S014_VIRAMUNE.pdf 7/27/2007
AP02/24/2005SLR11179014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20636s025,20933s014lbl.pdf 3/2/2005
AP02/24/2005SLR11180014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20636s025,20933s014ltr.pdf 3/2/2005
AP04/13/2007SLR16243015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s026,020933s015ltr.pdf 4/20/2007
AP04/13/2007SLR16268015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.pdf 4/20/2007
AP06/24/2008SE520079017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020636s027,020933s017lbl.pdf 6/26/2008
AP06/24/2008SE520097017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020636s027, 020933s017ltr.pdf 6/30/2008
AP08/16/2007SLR17637019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s029,020933s019lbl.pdf 8/17/2007
AP08/16/2007SLR17645019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s029,020933s019ltr.pdf 8/17/2007
AP01/13/2010SLR24547022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf 1/20/2010
AP01/13/2010SLR24645022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020933s022,020636s032ltr.pdf 1/26/2010
AP07/20/2010SLR25993026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf 7/22/2010
AP07/20/2010SLR26012026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020636s035,020933s026ltr.pdf 7/23/2010
AP01/7/2011SLR27504027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s036,020933s027lbl.pdf 1/10/2011
AP01/7/2011SLR27526027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s036,020933s027ltr.pdf 1/14/2011
AP03/25/2011SLR28395028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf 3/28/2011
AP03/25/2011SLR28409028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s028,020636s037ltr.pdf 3/31/2011
AP05/6/2011SLR28774029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf 5/10/2011
AP011/9/2011SLR30552030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s039_020933s030lbl.pdf 11/10/2011
AP011/9/2011SLR30563030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s039,020933s030ltr.pdf 11/14/2011
AP011/9/2012SLR34368033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020636Orig1s042,020933Orig1s033ltr.pdf 11/13/2012
AP011/9/2012SLR34385033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033lbl.pdf 11/15/2012
AP011/9/2012SLR34386033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033mg.pdf 11/15/2012
AP02/8/2013SCM       
AP01/27/2014SLR38381035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020636Orig1s044,020933Orig1s035ltr.pdf 1/28/2014
AP01/27/2014SLR38393035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.pdf 1/28/2014
AP02/3/2015SCM       




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