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FDA Drug Application 020005 by CHIESI USA INC

Application Number020005
Application Type New Drug Application
Sponsor ApplicantCHIESI USA INC
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
AP02/21/1992N       
AP011/20/1992SLR       
AP011/4/1993SLR       
AP02/22/1996SCM       
AP01/7/1997SCP       
AP09/29/1999SLR       
AP011/9/2001SCP       
AP07/30/2002SCS       
AP08/26/2016SLR46908014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020005s014lbl.pdf 8/29/2016
AP08/26/2016SLR46932014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020005Orig1s014ltr.pdf 9/1/2016




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