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FDA Drug Application 203389 by RAPTOR INC

Application Number203389
Application Type New Drug Application
Sponsor ApplicantRAPTOR INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/30/2013N35900000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203389Orig1s000ltr_repl.pdf 5/1/2013
AP04/30/2013N35912000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203389s000lbl.pdf 5/1/2013
AP04/30/2013N38702000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203389Orig1s000TOC.cfm 3/6/2014
AP04/30/2013N38703000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203389Orig1s000SumR.pdf 3/6/2014
AP010/8/2013SCM       
AP010/18/2013SCM       
AP010/31/2013SCM       
AP01/30/2014SCM       
AP04/21/2014SCM       
AP08/14/2015SE843658010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203389s010lbl.pdf 8/17/2015
AP08/14/2015SE843666010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203389Orig1s010ltr.pdf 8/18/2015
AP012/2/2014SCM       
AP04/8/2015SCM       
AP09/9/2015SCM       
AP03/10/2016SCM       
AP05/13/2016SCM       
AP03/21/2016SCM       




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