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FDA Drug Application 205075 by GLENMARK PHARMS LTD

Application Number205075
Application Type Abbreviated New Drug Application
Sponsor ApplicantGLENMARK PHARMS LTD
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
TA05/14/2015TA46044000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205075Orig1s000ltr.pdf 5/18/2016
AP15/16/2016N46044000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205075Orig1s000ltr.pdf 5/18/2016
TA05/14/2015TA46170000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205075Orig1s000lbl.pdf 5/26/2016
AP15/16/2016N46170000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205075Orig1s000lbl.pdf 5/26/2016




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