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FDA Drug Application 076258 by MYLAN TECHNOLOGIES

Application Number076258
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN TECHNOLOGIES
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
AP011/21/2003N9523000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76-258.rescind.ltr.pdf 6/24/2004
AP011/21/2003N11061000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076258ltr.pdf 2/1/2005
AP011/21/2003N12069000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076258.pdf 7/22/2005
AP011/21/2003N43143000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
TA16/22/2004TA9523000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76-258.rescind.ltr.pdf 6/24/2004
TA16/22/2004TA11061000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076258ltr.pdf 2/1/2005
TA16/22/2004TA12069000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076258.pdf 7/22/2005
TA16/22/2004TA43143000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP21/28/2005N9523000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76-258.rescind.ltr.pdf 6/24/2004
AP21/28/2005N11061000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076258ltr.pdf 2/1/2005
AP21/28/2005N12069000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076258.pdf 7/22/2005
AP21/28/2005N43143000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP01/23/2007SCQ       
AP01/23/2007SCQ       




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