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FDA Drug Application 075945 by MYLAN PHARMS INC

Application Number075945
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN PHARMS 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
AP011/8/2002N4392000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75945ltr.pdf 11/8/2002
AP011/8/2002N7258000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094305.htm 12/17/2003
AP011/8/2002N43204000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=24 7/2/2015
AP011/2/2007SLR32258011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/075945Orig1s011.pdf 3/28/2012
AP03/25/2010SLR32259014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/075945Orig1s014.pdf 3/28/2012




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