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FDA Drug Application 021515 by VALEANT INTL

Application Number021515
Application Type New Drug Application
Sponsor ApplicantVALEANT INTL
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
AP08/29/2003N6601000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21515ltr.pdf 9/9/2003
AP08/29/2003N6602000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21515_wellbutrin_lbl.pdf 9/9/2003
AP08/29/2003N11461000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021515_Wellbutrin.cfm 4/27/2005
AP08/29/2003N12328000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103318.htm 7/28/2005
AP08/29/2003N24205000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM172744.pdf 12/4/2009
AP010/28/2004SLR10500002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21515s002ltr.pdf 10/29/2004
AP05/27/2004SLR8834007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18644slr028,20358slr032,21515slr007ltr.pdf 6/1/2004
AP05/27/2004SLR16863007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/018644s027s028,020358s031s032,021515s006s007_WellbutrinTOC.cfm 6/29/2007
AP01/12/2005SLR10974009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/18644s030,20358s034,21515s009,20711s021ltr.pdf 1/13/2005
AP01/12/2005SLR10994009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18644s030,20358s034,21515s009,20711s021lbl.pdf 1/13/2005
AP06/12/2006SE114303010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021515s010s018lbl.pdf 6/14/2006
AP06/12/2006SE114306010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s010,021515s018LTR.pdf 6/14/2006
AP02/28/2006SLR13721012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s012_020358s035_018644s031ltr.pdf 3/3/2006
AP07/3/2006SLR14423014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018644s33s34,020358s37s40,021515s14lbl.pdf 7/5/2006
AP07/3/2006SLR14469014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018644s33,018644s34,020358s37,020358s40,021515s14LTR.pdf 7/13/2006
AP06/12/2006SLR14307018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021515s010,021515s018LTR.pdf 6/14/2006
AP06/12/2006SLR14311018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021515s010s018lbl.pdf 6/14/2006
AP08/2/2007SLR17494020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021515s020lbl.pdf 8/3/2007
AP08/2/2007SLR17594020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018644s036, 020358s043, 021515s020, 020711s029ltr.pdf 8/7/2007
AP05/25/2010SLR25623022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021515s022ltr.pdf 5/27/2010
AP05/25/2010SLR25650022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021515s022lbl.pdf 5/28/2010
AP07/1/2009SLR22901023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021515s023,02515s024ltr.pdf 7/8/2009
AP07/1/2009SLR22922023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021515s023s024lbl.pdf 7/9/2009
AP07/1/2009SLR22902024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021515s023,02515s024ltr.pdf 7/8/2009
AP07/1/2009SLR22923024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021515s023s024lbl.pdf 7/9/2009
AP02/26/2010SLR24922025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021515s025MedGuide.pdf 3/3/2010
AP07/26/2011SLR29613026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027lbl.pdf 7/27/2011
AP07/26/2011SLR29614026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027MedG.pdf 7/27/2011
AP07/26/2011SLR29625026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf 7/28/2011
AP07/26/2011SLR29612027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027lbl.pdf 7/27/2011
AP07/26/2011SLR29615027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021515s026s027MedG.pdf 7/27/2011
AP07/26/2011SLR29626027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021515s026,s027,022108s005,s006ltr.pdf 7/28/2011
AP08/2/2012S33365028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021515Orig1s028ltr.pdf 8/3/2012
AP012/30/2014SLR41487029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf 1/5/2015
AP012/30/2014SLR41500029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf 1/7/2015
AP012/30/2014SLR41488030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s029s030lbl.pdf 1/5/2015
AP012/30/2014SLR41501030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s029,s030,022108Orig1s009ltr.pdf 1/7/2015
AP011/21/2014SCM       
AP07/11/2014SLR39857032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021515Orig1s032ltr.pdf 7/15/2014
AP07/11/2014SLR39862032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021515s032lbl.pdf 7/15/2014
AP05/24/2016SCM       
AP08/30/2016SLR46944034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021515Orig1s034ltr.pdf 9/2/2016
AP08/30/2016SLR46967034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021515s034lbl.pdf 9/2/2016




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