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FDA Drug Application 021358 by BRACCO

Application Number021358
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
AP011/23/2004N10671000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21357,21358ltr.pdf 12/2/2004
AP011/23/2004N11053000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021358lbl.pdf 1/26/2005
AP011/23/2004N11431000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021358s000_021357s000_MultiHance.cfm 4/17/2005
AP011/23/2004N14262000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP09/4/2007SLR17755003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021357s003,021358s003lbl.pdf 9/6/2007
AP09/4/2007SLR17772003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021357s003, 021358s003ltr.pdf 9/6/2007
AP02/16/2011SLR27927008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021358s008ltr.pdf 2/18/2011
AP02/16/2011SLR27946008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021358s008lbl.pdf 2/24/2011
AP07/6/2012SE133098009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021357s011,021358s009ltr.pdf 7/9/2012
AP07/6/2012SE133105009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021358s009lbl.pdf 7/10/2012
AP09/29/2011SLR30202010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021358s010ltr.pdf 10/3/2011
AP01/29/2013SCM       
AP07/30/2013SLR36676012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021357Orig1s013,021358Orig1s012ltr.pdf 8/1/2013
AP07/30/2013SLR36753012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021357s013,021358s012lbl.pdf 8/9/2013




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