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FDA Drug Application 018304 by FRESENIUS KABI USA

Application Number018304
Application Type 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
AP012/30/1981N       
AP09/24/1987SC       
AP05/11/1988SL       
AP08/27/1991SL       
AP010/27/1989SC       
AP08/1/1989SC       
AP08/1/1989SC       
AP08/27/1991SL       
AP011/8/1991SC       
AP05/8/1992SC       
AP03/10/1993SC       
AP09/11/1992SC       
AP012/27/1994SS       
AP010/14/1997SC       
AP05/31/1996SC       
AP04/14/1997SC       
AP07/30/1999SC       
AP06/1/2001SL       
AP06/8/2001SCS       
AP03/8/2002SS       
AP012/23/2002SS       
AP01/29/2016SCM       
AP07/10/2015SLR43348044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf 7/13/2015
AP07/10/2015SLR43353044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018304Orig1s044,s045ltr.pdf 7/14/2015
AP07/10/2015SLR43349045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018304s044s045lbl.pdf 7/13/2015
AP07/10/2015SLR43354045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018304Orig1s044,s045ltr.pdf 7/14/2015




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