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FDA Drug Application 076703 by APOTEX INC

Application Number076703
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
TA011/30/2004TA11054000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076703ltr.pdf 1/27/2005
TA011/30/2004TA18232000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076703_ORIGINAL APPROVAL_PACKAGE.pdf 10/11/2007
AP11/27/2005N11054000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076703ltr.pdf 1/27/2005
AP11/27/2005N18232000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076703_ORIGINAL APPROVAL_PACKAGE.pdf 10/11/2007




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