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FDA Drug Application 090431 by MYLAN

Application Number090431
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN
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
AP012/28/2010N       
AP05/19/2016SCQ46177004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s004ltr.pdf 5/27/2016
AP04/29/2016SCQ45841005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/090431Orig1s005lbl.pdf 5/3/2016
AP04/29/2016SCQ45857005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s005ltr.pdf 5/4/2016
AP05/23/2016SCQ46137010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/090431Orig1s010ltr.pdf 5/25/2016
AP05/23/2016SCQ46167010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/90431Orig1s010lbl.pdf 5/26/2016




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