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FDA Drug Application 050536 by MAYNE PHARMA

Application Number050536
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
AP01/26/1981N       
AP04/22/1981SCM       
AP05/21/1981SLR       
AP05/18/1981SCS       
AP05/20/1981SCS       
AP06/5/1981SLR       
AP06/16/1986SCF       
AP06/5/1981SCS       
AP06/15/1981SLR       
AP08/7/1981SLR       
AP01/28/1982SCM       
AP03/30/1982SCE       
AP09/22/2000SLR       
AP010/21/1997SCS       
AP08/5/1999SCS       
AP02/2/2004SLR7738016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50536slr016ltr.pdf 2/27/2004
AP012/18/2003SLR7304018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50536slr018ltr.pdf 12/22/2003
AP01/12/2006SLR13391019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050536s019lbl.pdf 1/13/2006
AP01/12/2006SLR13460019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050536s019ltr.pdf 1/20/2006
AP02/21/2008SLR19280020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050536s020lbl.pdf 2/25/2008
AP02/21/2008SLR19295020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050536s020ltr.pdf 2/25/2008
AP03/20/2013SLR35498021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050536Orig1s021ltr_corrected.pdf 3/22/2013
AP03/20/2013SLR35535021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050536s021lbl.pdf 3/26/2013
AP02/14/2012SLR31833022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050536s022lbl.pdf 2/17/2012
AP02/14/2012SLR31836022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050536s022ltr.pdf 2/21/2012
AP012/19/2013SCM       
AP012/19/2013SCM       




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