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FDA Drug Application 020131 by BRACCO

Application Number020131
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
AP011/16/1992N14265000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142882.htm 6/9/2006
AP011/21/1994SE1       
AP011/21/1994SE1       
AP010/26/1993SCS       
AP05/8/1995SLR       
AP010/8/1996SCS       
AP09/30/2002SLR3948009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20131slr009,0016ltr.pdf 9/30/2002
AP02/1/1996SCS       
AP04/8/1997SCS       
AP01/29/1997SCM       
AP06/13/1997SCM       
AP06/13/1997SCM       
AP04/2/1998SCM       
AP09/30/2002SLR3949016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20131slr009,0016ltr.pdf 9/30/2002
AP01/24/2001SCM       
AP03/9/2001SCM       
AP07/19/2001SCM       
AP06/3/2002SCM       
AP09/4/2007SLR17754023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020131s023,021489s001lbl.pdf 9/6/2007
AP09/4/2007SLR17769023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020131s023, 021489s001ltr.pdf 9/6/2007
AP012/20/2010SLR27320024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020131s024lbl.pdf 12/20/2010
AP012/20/2010SLR27333024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020131s024,021489s002ltr.pdf 12/22/2010
AP08/13/2013SLR36807026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020131s026,021489s003lbl.pdf 8/15/2013
AP08/13/2013SLR36811026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020131Orig1s026,021489Orig1s003ltr.pdf 8/16/2013




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