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FDA Drug Application 204592 by IROKO PHARMS LLC

Application Number204592
Application Type New Drug Application
Sponsor ApplicantIROKO PHARMS LLC
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
AP010/18/2013N37494000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204592Orig1s000ltr.pdf 10/22/2013
AP010/18/2013N37519000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204592s000lbl.pdf 10/22/2013
AP010/18/2013N37548000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372061.pdf 10/24/2013
AP010/18/2013N38911000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204592Orig1s000TOC.cfm 3/26/2014
AP010/18/2013N38912000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204592Orig1s000SumR.pdf 3/26/2014
AP04/14/2014SCM       
AP08/22/2014SE840316002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf 8/26/2014
AP08/22/2014SE840319002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204592Orig1s002,s004ltr.pdf 8/27/2014
AP08/11/2014SCM       
AP08/22/2014SE840320004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204592Orig1s002,s004ltr.pdf 8/27/2014
AP08/22/2014SE840317004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204592s002s004lbl.pdf 8/26/2014
AP01/29/2015SCM       
AP05/9/2016SLR45968007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf 5/11/2016
AP05/9/2016SLR45897007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204592Orig1s007,s008ltr.pdf 5/10/2016
AP05/9/2016SLR45898008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204592Orig1s007,s008ltr.pdf 5/10/2016
AP05/9/2016SLR45969008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204592s007s008lbl.pdf 5/11/2016




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