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FDA Drug Application 021489 by BRACCO

Application Number021489
Application Type New Drug Application
Sponsor ApplicantBRACCO
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
AP010/9/2003N6795000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21489ltr.pdf 10/16/2003
AP010/9/2003N6796000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21489_proHance_lbl.pdf 10/16/2003
AP010/9/2003N14266000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP010/9/2003N14531000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021489s000_ProhanceTOC.cfm 7/25/2006
AP09/4/2007SLR17753001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf 9/6/2007
AP09/4/2007SLR17768001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020131s023, 021489s001ltr.pdf 9/6/2007
AP012/20/2010SLR27321002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021489s002lbl.pdf 12/20/2010
AP012/20/2010SLR27334002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020131s024,021489s002ltr.pdf 12/22/2010
AP08/13/2013SLR36806003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf 8/15/2013
AP08/13/2013SLR36812003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020131Orig1s026,021489Orig1s003ltr.pdf 8/16/2013
AP07/22/2014SLR39970004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021489s004lbl.pdf 7/24/2014
AP07/22/2014SLR39993004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021489Orig1s004ltr.pdf 7/24/2014




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