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FDA Drug Application 022156 by CHIESI USA INC

Application Number022156
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
AP08/1/2008N20515000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022156s000ltr.pdf 8/8/2008
AP08/1/2008N20879000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022156_cleviprex_toc.cfm 9/23/2008
AP08/1/2008N20880000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022156s000_SumR.pdf 9/23/2008
AP012/8/2011SLR30945003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022156s003lbl.pdf 12/13/2011
AP012/8/2011SLR30949003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022156s003ltr.pdf 12/14/2011
AP011/8/2013SCM       
AP06/23/2015SCM       




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