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FDA Drug Application 016084 by SEBELA IRELAND LTD

Application Number016084
Application Type New Drug Application
Sponsor ApplicantSEBELA IRELAND LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/19/1966N       
AP01/16/1976SCS       
AP012/6/1976SLR       
AP04/6/1977SCS       
AP01/30/1980SCP       
AP02/1/1980SCP       
AP05/16/1989SCS       
AP02/25/1985SPD       
AP012/10/1982SCP       
AP06/10/1982SCS       
AP06/10/1982SCP       
AP01/27/1986SCS       
AP012/8/1982SLR       
AP06/1/1983SCF       
AP02/27/1985SCS       
AP06/7/1985SCS       
AP07/11/1991SCS       
AP07/17/2002SLR2235041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16084slr041ltr.pdf 7/17/2002
AP07/17/2002SLR17222041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/016084_S041_Zyloprim Tablets.pdf 7/9/2007




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