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FDA Drug Application 202535 by FERRING PHARMS AS

Application Number202535
Application Type New Drug Application
Sponsor ApplicantFERRING PHARMS AS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/16/2012N33211000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202535Orig1s000ltr.pdf 7/17/2012
AP07/16/2012N33219000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202535lbl.pdf 7/18/2012
AP07/16/2012N33220000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM312633.pdf 7/18/2012
AP07/16/2012N33351000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535_prepopik_toc.cfm 8/3/2012
AP07/16/2012N33352000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202535Orig1s000SumR.pdf 8/3/2012
AP05/13/2013SCM       
AP08/21/2014SCM       
AP05/6/2016SCM       




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