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FDA Drug Application 078936 by MYLAN PHARMS INC

Application Number078936
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
TA02/4/2015TA41802000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078936Orig1s000TAltr.pdf 2/6/2015
TA02/4/2015TA43572000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078936Orig1s000lbl.pdf 8/4/2015
TA02/4/2015TA43578000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078936Orig1s000ltr.pdf 8/6/2015
AP18/3/2015N41802000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078936Orig1s000TAltr.pdf 2/6/2015
AP18/3/2015N43572000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078936Orig1s000lbl.pdf 8/4/2015
AP18/3/2015N43578000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078936Orig1s000ltr.pdf 8/6/2015




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