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FDA Drug Application 078126 by APOTEX INC

Application Number078126
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
TA07/27/2007TA17551000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078126s000lbl.pdf 8/7/2007
TA07/27/2007TA17558000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078126s000ltr.pdf 8/7/2007
AP18/6/2007N17551000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/078126s000lbl.pdf 8/7/2007
AP18/6/2007N17558000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078126s000ltr.pdf 8/7/2007
AP06/24/2016SLR       
AP06/24/2016SLR       
AP06/24/2016SLR       
AP06/24/2016SLR       




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