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FDA Drug Application 205095 by MYLAN PHARMS INC

Application Number205095
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN PHARMS INC
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
TA04/16/2015TA46045000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205095Orig1s000ltr.pdf 5/18/2016
TA04/16/2015TA46081000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205095Orig1s000lbl.pdf 5/20/2016
AP15/16/2016N46045000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205095Orig1s000ltr.pdf 5/18/2016
AP15/16/2016N46081000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205095Orig1s000lbl.pdf 5/20/2016




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