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FDA Drug Application 050795 by MAYNE PHARMA

Application Number050795
Application Type New Drug Application
Sponsor ApplicantMAYNE PHARMA
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
AP05/6/2005N11631000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050795ltr.pdf 5/17/2005
AP05/6/2005N11656000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050795lbl.pdf 5/17/2005
AP05/6/2005N13977000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/050795s000_DoryxTOC.cfm 4/21/2006
AP012/19/2006SE815490002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050795s002lbl.pdf 12/26/2006
AP012/19/2006SE815527002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050795s002ltr.pdf 12/28/2006
AP012/18/2007SLR18680003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050795s003lbl.pdf 12/27/2007
AP012/18/2007SLR18816003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050795s003ltr.pdf 1/9/2008
AP06/20/2008SCF20073005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050795s005ltr.pdf 6/24/2008
AP06/20/2008SCF20091005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050795s005lbl.pdf 6/26/2008
AP04/11/2013SE835703010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050795Orig1s010ltr.pdf 4/16/2013
AP04/11/2013SE835722010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050795s010lbl.pdf 4/16/2013
AP04/11/2013SCM       
AP03/21/2011SLR28337013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050582s028,050795s013ltr.pdf 3/24/2011
AP03/21/2011SLR28381013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s013lbl.pdf 3/28/2011
AP09/13/2011SCM30023014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050795s014lbl.pdf 9/16/2011
AP011/25/2013SCM       
AP012/6/2013SCM       
AP012/6/2013SCM       
AP06/4/2015SLR43009018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050795Orig1s018ltr.pdf 6/10/2015
AP06/4/2015SLR43025018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795s018lbl.pdf 6/10/2015
AP012/19/2014SCM44516019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/050795Orig1s019.pdf 11/18/2015
AP012/19/2014SCM45569019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050795Orig1s019lbl.pdf 4/1/2016
AP012/19/2014SCM45570019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050795Orig1s019ltr.pdf 4/1/2016
AP03/4/2015SLR42038020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050795Orig1s020ltr.pdf 3/6/2015
AP03/4/2015SLR42131020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050795Orig1s020lbl.pdf 3/12/2015
AP15/18/2016SLR46088021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050795Orig1s021ltr.pdf 5/20/2016
AP15/18/2016SLR46089021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s021lbl.pdf 5/20/2016
AP05/20/2016SE846108022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050795s022lbl.pdf 5/23/2016
AP05/20/2016SE846118022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050795Orig1s022ltr.pdf 5/24/2016
AP010/18/2016SCM       




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