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FDA Drug Application 091471 by MYLAN PHARMS INC

Application Number091471
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
TA03/28/2011TA45205000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091471Orig1s000ltr.pdf 2/19/2016
AP12/17/2016N45205000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091471Orig1s000ltr.pdf 2/19/2016
TA03/28/2011TA45233000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/091471Orig1s000lbl.pdf 2/23/2016
AP12/17/2016N45233000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/091471Orig1s000lbl.pdf 2/23/2016




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