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FDA Drug Application 017814 by IROKO PHARMS

Application Number017814
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
AP08/13/1984N       
AP011/27/1984SLR       
AP07/23/1985SLR       
AP01/6/1986SLR       
AP06/4/1986SLR       
AP08/15/1986SLR       
AP09/19/1986SLR       
AP06/3/1988SLR       
AP01/6/1989SLR       
AP03/10/1988SCS       
AP01/9/1989SLR       
AP01/6/1989SLR       
AP05/23/1989SLR       
AP09/26/1994SLR       
AP012/30/1994SCS       
AP09/13/1994SLR       
AP010/24/1994SLR       
AP010/31/2001SLR       
AP010/3/1997SCS       
AP010/6/1999SCS       
AP011/3/1997SCS       
AP010/29/1997SCS       
AP02/4/2000SCM       
AP03/24/2005SLR11300038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf 3/29/2005
AP01/26/2006SLR13502039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf 1/27/2006
AP01/30/2007SLR15738040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf 2/2/2007
AP01/30/2007SLR15755040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016059s097, 017814s040, 018332s030.pdf 2/2/2007
AP05/9/2016SLR45930041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042ltr.pdf 5/11/2016
AP05/9/2016SLR45948041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf 5/11/2016
AP05/9/2016SLR45931042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017814Orig1s041,s042ltr.pdf 5/11/2016
AP05/9/2016SLR45949042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017814s041s042lbl.pdf 5/11/2016




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