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FDA Drug Application 018185 by IROKO PHARMS

Application Number018185
Application Type New Drug Application
Sponsor ApplicantIROKO PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/23/1982N       
AP02/1/1983SCS       
AP010/19/1982SLR       
AP02/1/1983SLR       
AP02/1/1983SLR       
AP010/5/1984SCS       
AP010/31/1983SLR       
AP01/6/1986SLR       
AP06/25/1984SCM       
AP05/3/1984SCM       
AP011/27/1984SLR       
AP010/3/1984SCM       
AP011/20/1984SCM       
AP02/21/1985SCM       
AP02/21/1985SCM       
AP09/30/1985SCM       
AP011/27/1984SLR       
AP07/23/1985SLR       
AP08/15/1986SLR       
AP09/19/1986SLR       
AP06/3/1988SLR       
AP02/10/1989SLR       
AP01/6/1989SLR       
AP03/10/1988SCS       
AP01/9/1989SLR       
AP01/6/1989SLR       
AP05/25/1989SLR       
AP09/26/1994SLR       
AP09/14/1994SLR       
AP012/30/1994SCS       
AP08/18/1994SCS       
AP09/14/1994SLR       
AP09/13/1994SLR       
AP010/24/1994SLR       
AP010/31/2001SLR       
AP03/1/1996SCM       
AP010/7/1997SCM       
AP010/11/2001SLR       
AP05/9/2016SLR46048055   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM501640.pdf 5/18/2016
AP05/9/2016SLR45933055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018185Orig1s055,s056ltr.pdf 5/11/2016
AP05/9/2016SLR45950055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf 5/11/2016
AP05/9/2016SLR45951056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018185s055s056lbl.pdf 5/11/2016
AP05/9/2016SLR45934056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018185Orig1s055,s056ltr.pdf 5/11/2016




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