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FDA Drug Application 022514 by BOEHRINGER INGELHEIM

Application Number022514
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/19/2010N25095000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022514s000ltr.pdf 3/24/2010
AP03/19/2010N25112000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022514lbl.pdf 3/26/2010
AP03/19/2010N26360000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022514_mirapex_er_toc.cfm 9/3/2010
AP03/19/2010N26361000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022514s000SumR.pdf 9/3/2010
AP03/19/2010N33796000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm320049.htm 9/19/2012




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