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FDA Drug Application 077605 by BARR

Application Number077605
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
TA05/10/2007TA20720000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077605s000ltr.pdf 8/29/2008
AP18/28/2008N20720000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077605s000ltr.pdf 8/29/2008
TA05/10/2007TA20838000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm 9/19/2008
AP18/28/2008N20838000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109350.htm 9/19/2008
TA05/10/2007TA21254000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077605s000lbl.pdf 11/20/2008
AP18/28/2008N21254000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/077605s000lbl.pdf 11/20/2008




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