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FDA Drug Application 076894 by APOTEX INC

Application Number076894
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
AP05/31/2005N20350000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076894_ORIGINAL APPROVAL_PACKAGE.pdf 7/31/2008
AP010/3/2007SCC20326001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/076894_S001_TORSEMIDE TABS.pdf 7/30/2008
AP011/7/2007S20327002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/076894_S002_TORSEMIDE TABS.pdf 7/30/2008
AP05/9/2008S20256003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076894_S003_TORSEMIDE TABS.pdf 7/18/2008
AP04/10/2008S20255004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/076894_S004_TORSEMIDE TABS.pdf 7/18/2008




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