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FDA Drug Application 203284 by HORIZON THERAPS INC

Application Number203284
Application Type New Drug Application
Sponsor ApplicantHORIZON THERAPS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/1/2013N35059000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203284Orig1s000ltr.pdf 2/4/2013
AP02/1/2013N35072000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM338056.pdf 2/5/2013
AP02/1/2013N35080000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203284s000lbl.pdf 2/6/2013
AP02/1/2013N35559000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203284Orig1s000TOC.cfm 3/28/2013
AP06/24/2014SLR39750001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203284s001lbl.pdf 7/3/2014
AP06/24/2014SLR39795001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203284Orig1s001ltr.pdf 7/8/2014
AP01/5/2015SCM       
AP07/27/2015SCM       
AP09/8/2016SE847019004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203284s004lbl.pdf 9/9/2016
AP09/8/2016SE847025004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203284Orig1s004ltr.pdf 9/12/2016




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