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FDA Drug Application 078458 by MAYNE PHARMA

Application Number078458
Application Type Abbreviated New Drug Application
Sponsor ApplicantMAYNE PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/1/2011N31997000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078458Orig1s000LBL.pdf 3/2/2012
AP112/13/2011N31997000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/078458Orig1s000LBL.pdf 3/2/2012
AP06/23/2016SCQ46415010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078458Orig1s010ltr.pdf 6/24/2016
AP06/23/2016SCQ46426010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/078458Orig1s010lbl.pdf 6/27/2016




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