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FDA Drug Application 050789 by FRESENIUS KABI USA

Application Number050789
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/14/2004N9748000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50789ltr.pdf 7/21/2004
AP07/14/2004N9828000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50789lbl.pdf 7/21/2004
AP07/14/2004N15208000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/050789s000_TobramycinTOC.cfm 10/25/2006
AP08/10/2009SLR23437005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050789s005lbl.pdf 9/22/2009
AP02/16/2013SCM       
AP08/10/2009SLR24161027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050789s027ltr.pdf 11/27/2009




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