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FDA Drug Application 076578 by MYLAN

Application Number076578
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN
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
TA07/17/2003TA16324000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 4/26/2007
TA07/17/2003TA16409000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076578s000ltr.pdf 5/1/2007
AP14/23/2007N16324000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101557.htm 4/26/2007
AP14/23/2007N16409000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/076578s000ltr.pdf 5/1/2007




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