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FDA Drug Application 076448 by BARR

Application Number076448
Application Type Abbreviated New Drug Application
Sponsor ApplicantBARR
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
AP012/17/2003N19039000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 2/1/2008
AP012/17/2003N22292000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076448s000ltr.pdf 4/21/2009
AP14/15/2009N19039000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 2/1/2008
AP14/15/2009N22292000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076448s000ltr.pdf 4/21/2009




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