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FDA Drug Application 019414 by BRACCO

Application Number019414
Application Type New Drug Application
Sponsor ApplicantBRACCO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/29/1989N31384000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm287453.htm 1/12/2012
AP03/6/1990SCM       
AP011/14/1991SCM       
AP011/21/1997SCM       
AP05/29/1998SCM       
AP03/23/1999SCM       
AP04/5/2001SCM4939006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19414S6ltr.pdf 4/11/2001
AP07/21/2009SLR23029011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019414s011ltr.pdf 7/23/2009
AP07/21/2009SLR23063011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019414s011lbl.pdf 7/23/2009
AP07/28/2010SE826043012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019414s012ltr.pdf 7/30/2010
AP07/28/2010SE826075012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019414s012lbl.pdf 7/31/2010
AP02/8/2012SLR31725014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019414s014lbl.pdf 2/9/2012
AP02/8/2012SLR31738014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019414s014ltr.pdf 2/10/2012
AP04/22/2013SCM       
AP012/5/2014SCM       




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