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FDA Drug Application 079161 by MYLAN PHARMS INC

Application Number079161
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
TA05/12/2010TA25557000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079161s000ltr.pdf 5/17/2010
TA17/2/2013TA25557000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079161s000ltr.pdf 5/17/2010
AP27/19/2016N25557000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079161s000ltr.pdf 5/17/2010
TA05/12/2010TA46561000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079161Orig1s000ltr.pdf 7/20/2016
TA17/2/2013TA46561000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079161Orig1s000ltr.pdf 7/20/2016
AP27/19/2016N46561000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079161Orig1s000ltr.pdf 7/20/2016




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