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FDA Drug Application 077603 by MYLAN

Application Number077603
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
TA06/1/2007TA20719000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077603s000ltr.pdf 8/29/2008
TA06/1/2007TA20839000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm 9/19/2008
AP18/28/2008N20719000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077603s000ltr.pdf 8/29/2008
AP18/28/2008N20839000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm 9/19/2008




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