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FDA Drug Application 018248 by FRESENIUS KABI USA

Application Number018248
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
AP07/9/1980N       
AP03/10/1982SCM       
AP04/14/1983SPF       
AP011/12/1982SCS       
AP08/10/1983SLR       
AP011/8/1983SCS       
AP07/23/1984SCS       
AP03/14/1985SCS       
AP010/14/1986SLR       
AP09/19/1986SCS       
AP02/24/1987SLR       
AP02/16/1988SCP       
AP01/20/1999SCM       
AP012/16/1994SCS       
AP01/13/1995SCS       
AP011/23/1994SLR       
AP010/17/1997SCM       
AP07/2/1999SCS       
AP02/22/1999SLR17140026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018248_S026_OXYTOCIN_AP.pdf 7/9/2007
AP05/31/2000SLR17141027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/018248_S027_OXYTOCIN_AP.pdf 7/9/2007
AP010/11/2000SCE       
AP07/27/2007SCS17423034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018248s034_ltr.pdf 7/30/2007
AP09/10/2014SCM       
AP09/15/2016SCM       




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