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FDA Drug Application 016059 by IROKO PHARMS LLC

Application Number016059
Application Type New Drug Application
Sponsor ApplicantIROKO PHARMS LLC
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
AP06/10/1965N       
AP08/27/1976SCS       
AP010/7/1981SLR       
AP06/29/1976SLR       
AP012/22/1977SLR       
AP010/11/1978SCS       
AP010/26/1979SCP       
AP02/23/1978SCS       
AP01/29/1979SCS       
AP09/24/1979SCM       
AP08/8/1979SLR       
AP010/26/1979SLR       
AP05/28/1981SLR       
AP07/29/1983SCP       
AP09/27/1980SLR       
AP04/9/1981SCS       
AP01/6/1986SES       
AP03/3/1982SCM       
AP08/13/1984SCP       
AP01/31/1983SCS       
AP011/18/1983SLR       
AP01/19/1983SCP       
AP05/11/1983SCM       
AP06/25/1984SCM       
AP012/6/1984SLR       
AP011/27/1984SLR       
AP07/23/1985SLR       
AP08/15/1986SLR       
AP06/4/1986SLR       
AP08/15/1986SLR       
AP09/22/1986SLR       
AP06/3/1988SLR       
AP01/6/1989SLR       
AP05/3/1988SCM       
AP01/9/1989SLR       
AP01/6/1989SLR       
AP05/25/1989SLR       
AP04/4/1991SCM       
AP09/26/1994SLR       
AP09/14/1994SLR       
AP012/30/1994SCS       
AP08/18/1994SCS       
AP09/13/1994SLR       
AP010/24/1994SLR       
AP010/31/2001SLR       
AP03/1/1996SCM       
AP012/1/1997SCS       
AP03/24/2005SLR11299095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/16059s095,17814s038,18332s028ltr.pdf 3/29/2005
AP01/26/2006SLR13503096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018332s029_017814s039_016059s096lbl.pdf 1/27/2006
AP01/30/2007SLR15739097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/016059s097,017814s040,018332s030lbl.pdf 2/2/2007
AP01/30/2007SLR15756097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/016059s097, 017814s040, 018332s030.pdf 2/2/2007
AP05/9/2016SLR45923098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016059Orig1s098,s099ltr.pdf 5/11/2016
AP05/9/2016SLR45944098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf 5/11/2016
AP05/9/2016SLR45945099   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/016059s098s099lbl.pdf 5/11/2016
AP05/9/2016SLR45924099   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/016059Orig1s098,s099ltr.pdf 5/11/2016




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