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FDA Drug Application 021357 by BRACCO

Application Number021357
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
AP011/23/2004N10670000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21357,21358ltr.pdf 12/2/2004
AP011/23/2004N10719000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021357lbl.pdf 12/3/2004
AP011/23/2004N11289000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021357_021358_Multihance.cfm 3/28/2005
AP011/23/2004N14261000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP09/4/2007SLR17756003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021357s003,021358s003lbl.pdf 9/6/2007
AP09/4/2007SLR17773003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021357s003, 021358s003ltr.pdf 9/6/2007
AP010/2/2009SLR23566004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021357s004lbl.pdf 10/14/2009
AP010/2/2009SLR23785004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021357s004ltr.pdf 11/10/2009
AP03/17/2010SE525073006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s006lbl.pdf 3/18/2010
AP03/17/2010SE525087006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021357s006ltr.pdf 3/22/2010
AP012/20/2010SLR27314009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021357s009lbl.pdf 12/20/2010
AP012/20/2010SLR27332009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021357s009ltr.pdf 12/22/2010
AP07/6/2012SE133097011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021357s011,021358s009ltr.pdf 7/9/2012
AP07/6/2012SE133102011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021357s011lbl.pdf 7/10/2012
AP01/29/2013SCM       
AP07/30/2013SLR36675013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021357Orig1s013,021358Orig1s012ltr.pdf 8/1/2013
AP07/30/2013SLR36754013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021357s013,021358s012lbl.pdf 8/9/2013




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