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FDA Drug Application 020636 by BOEHRINGER INGELHEIM

Application Number020636
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
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
AP06/21/1996N15874000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089818.pdf 2/22/2007
AP011/21/1997SCS       
AP05/20/1998SE117511002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020636_S002_VIRAMUNE.pdf 8/6/2007
AP01/16/1998SCS       
AP09/24/1997SCS       
AP09/19/1997SCP17509005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020636_S005_VIRAMUNE.pdf 8/6/2007
AP05/20/1998SLR17510007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020636_S007_VIRAMUNE.pdf 8/6/2007
AP09/11/1998SE19634009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Prntlbl.pdf 6/30/2004
AP09/11/1998SE19635009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_Viramune_Approv.pdf 6/30/2004
AP09/11/1998SE17678009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-933_20-636S009_Viramune.cfm 2/4/2004
AP06/1/1999SCM       
AP010/25/1999SLR       
AP08/5/1999SCM17508012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020636_S012_VIRAMUNE.pdf 8/6/2007
AP08/10/2000SLR       
AP011/6/2000SLR       
AP02/23/2001SCS       
AP012/31/2002SLR9633016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636slr016,20933slr006ltr.pdf 6/30/2004
AP012/31/2002SLR4894016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20636slr016,20933slr006_viramune_lbl.pdf 4/4/2003
AP03/27/2002SE72793017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20636s17ltr.pdf 3/27/2002
AP03/27/2002SE711468017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020636s017_020933s007_Viramune.cfm 4/27/2005
AP012/18/2002SCS       
AP07/29/2003SLR6406020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr020,20933slr010ltr.pdf 8/6/2003
AP07/29/2003SLR6408020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr020,20933slr010_viramune_lbl.pdf 8/6/2003
AP012/22/2003SLR7351021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20636slr021,20933slr011ltr.pdf 12/23/2003
AP012/22/2003SLR7430021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20636slr021,20933slr011_viramune_lbl.pdf 12/29/2003
AP05/24/2004SLR8656022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20636slr022ltr.pdf 5/26/2004
AP05/24/2004SLR8701022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20636slr022_viramune_lbl.pdf 5/27/2004
AP02/24/2005SLR17507025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020636_S025_VIRAMUNE.pdf 8/6/2007
AP02/24/2005SLR11178025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20636s025,20933s014lbl.pdf 3/2/2005
AP02/24/2005SLR11181025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20636s025,20933s014ltr.pdf 3/2/2005
AP04/13/2007SLR16244026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s026,020933s015ltr.pdf 4/20/2007
AP04/13/2007SLR16269026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s026,020933s015lbl.pdf 4/20/2007
AP06/24/2008SE520080027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020636s027,020933s017lbl.pdf 6/26/2008
AP06/24/2008SE520096027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020636s027, 020933s017ltr.pdf 6/30/2008
AP08/16/2007SLR17636029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020636s029,020933s019lbl.pdf 8/17/2007
AP08/16/2007SLR17644029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020636s029,020933s019ltr.pdf 8/17/2007
AP01/13/2010SLR24546032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020933s022,020636s032lbl.pdf 1/20/2010
AP01/13/2010SLR24646032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020933s022,020636s032ltr.pdf 1/26/2010
AP07/20/2010SLR25994035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020636s035,020933s026lbl.pdf 7/22/2010
AP07/20/2010SLR26011035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020636s035,020933s026ltr.pdf 7/23/2010
AP01/7/2011SLR27505036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s036,020933s027lbl.pdf 1/10/2011
AP01/7/2011SLR27525036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s036,020933s027ltr.pdf 1/14/2011
AP03/25/2011SLR28394037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020933s028,020636s037lbl.pdf 3/28/2011
AP03/25/2011SLR28410037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s028,020636s037ltr.pdf 3/31/2011
AP05/6/2011SLR28775038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020933s029,020636s038,201152s001ltr.pdf 5/10/2011
AP011/9/2011SLR30551039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020636s039_020933s030lbl.pdf 11/10/2011
AP011/9/2011SLR30562039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020636s039,020933s030ltr.pdf 11/14/2011
AP011/9/2012SLR34367042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020636Orig1s042,020933Orig1s033ltr.pdf 11/13/2012
AP011/9/2012SLR34383042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033mg.pdf 11/15/2012
AP011/9/2012SLR34384042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020636s042,020933s033lbl.pdf 11/15/2012
AP01/27/2014SLR38380044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020636Orig1s044,020933Orig1s035ltr.pdf 1/28/2014
AP01/27/2014SLR38394044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020636s044,020933s035lbl.pdf 1/28/2014
AP04/14/2016SCM       




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