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FDA Drug Application 078350 by APOTEX INC

Application Number078350
Application Type Abbreviated New Drug Application
Sponsor ApplicantAPOTEX 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
TA011/9/2011TA44726000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078350Orig1s000ltr.pdf 12/9/2015
AP112/7/2015N44726000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/078350Orig1s000ltr.pdf 12/9/2015




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