Back to FDA Applications sponsored by CHIESI USA INC

FDA Drug Application 201820 by CHIESI USA INC

Application Number201820
Application Type New Drug Application
Sponsor ApplicantCHIESI USA 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
AP010/12/2012N34098000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201820s000lbl.pdf 10/15/2012
AP010/12/2012N34111000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201820Orig1s000ltr.pdf 10/16/2012
AP010/12/2012N36931000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201820_bethkis_toc.cfm 9/3/2013
AP010/12/2012N36932000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201820Orig1s000SumR.pdf 9/3/2013
AP02/16/2015SCM       




Back to FDA Applications sponsored by CHIESI USA INC