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FDA Drug Application 075761 by FRESENIUS KABI USA

Application Number075761
Application Type Abbreviated New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/15/2002N5250000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75761.TA.pdf 4/15/2003
TA18/23/2001TA5250000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75761.TA.pdf 4/15/2003
AP010/15/2002N12309000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm 7/28/2005
TA18/23/2001TA12309000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm 7/28/2005
AP010/15/2002N13965000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075761_s000_AmiodaroneTOC.cfm 4/20/2006
TA18/23/2001TA13965000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075761_s000_AmiodaroneTOC.cfm 4/20/2006




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