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FDA Drug Application 018332 by IROKO PHARMS

Application Number018332
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
AP010/10/1985N23999000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088612.pdf 11/19/2009
AP01/6/1986SLR       
AP06/4/1986SCP       
AP09/19/1986SLR       
AP08/15/1986SLR       
AP06/3/1988SLR       
AP01/6/1989SLR       
AP03/10/1988SCS       
AP01/9/1989SLR       
AP01/6/1989SLR       
AP05/25/1989SLR       
AP09/26/1994SLR       
AP012/30/1994SCS       
AP09/13/1994SLR       
AP010/24/1994SLR       
AP010/31/2001SLR       
AP04/28/1998SCS       
AP011/26/2001SLR       
AP03/24/2005SLR11301028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf 3/29/2005
AP01/26/2006SLR13501029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf 1/27/2006
AP01/30/2007SLR15737030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf 2/2/2007
AP01/30/2007SLR15754030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016059s097, 017814s040, 018332s030.pdf 2/2/2007
AP03/31/2009SLR22201032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/018332s032lbl.pdf 4/3/2009
AP05/9/2013SCM       
AP010/16/2014SCM       
AP05/9/2016SLR45946037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf 5/11/2016
AP05/9/2016SLR45999037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018332Orig1s037,s038ltr.pdf 5/12/2016
AP05/9/2016SLR46007038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/018332Orig1s037,s038ltr.pdf 5/12/2016
AP05/9/2016SLR45947038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/018332s037s038lbl.pdf 5/11/2016




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