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FDA Drug Application 078462 by AUROBINDO PHARMA

Application Number078462
Application Type Abbreviated New Drug Application
Sponsor ApplicantAUROBINDO PHARMA
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
AP09/7/2007N19040000   http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 2/1/2008
AP13/27/2009N19040000   http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm 2/1/2008
AP09/7/2007N22154000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078462s000ltr.pdf 4/1/2009
AP13/27/2009N22154000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078462s000ltr.pdf 4/1/2009
AP09/7/2007N22246000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 4/14/2009
AP13/27/2009N22246000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 4/14/2009
AP011/4/2010SLR       




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