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FDA Drug Application 202958 by APOTEX INC

Application Number202958
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
TA05/17/2013TA42008000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202958Orig1s000ltr.pdf 3/4/2015
TA05/17/2013TA42132000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202958Orig1s000lbl.pdf 3/12/2015
AP12/25/2015N42008000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202958Orig1s000ltr.pdf 3/4/2015
AP12/25/2015N42132000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202958Orig1s000lbl.pdf 3/12/2015




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