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FDA Drug Application 090449 by APOTEX INC

Application Number090449
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
TA012/27/2010TA43432000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090449Orig1s000ltr.pdf 7/22/2015
TA012/27/2010TA43458000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090449Orig1s000lbl.pdf 7/23/2015
AP17/20/2015N43432000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090449Orig1s000ltr.pdf 7/22/2015
AP17/20/2015N43458000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/090449Orig1s000lbl.pdf 7/23/2015




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