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FDA Drug Application 019488 by CHIESI USA INC

Application Number019488
Application Type New Drug Application
Sponsor ApplicantCHIESI USA INC
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
AP012/21/1988N       
AP04/18/1989SCS       
AP09/12/1989SCS       
AP09/12/1989SCP       
AP06/7/1990SCP       
AP010/16/1990SCS       
AP012/17/1992SCF       
AP012/30/1994SCM       
AP09/20/1999SLR       
AP011/9/2001SCP       
AP08/26/2016SLR46901010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019488Orig1s010ltr.pdf 8/29/2016
AP08/26/2016SLR46910010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019488s010lbl.pdf 8/29/2016




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