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FDA Drug Application 065162 by TEVA

Application Number065162
Application Type Abbreviated New Drug Application
Sponsor ApplicantTEVA
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
AP03/12/2004N17116000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/065162_ORIGINAL APPROVAL_PACKAGE.pdf 7/6/2007
AP03/5/2009S26781021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/065162s021lbl.pdf 10/26/2010
AP03/5/2009S26925021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/065162s021ltr.pdf 11/10/2010




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