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FDA Drug Application 022052 by CHIESI USA INC

Application Number022052
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
AP05/30/2007N16668000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022052s000ltr.pdf 6/4/2007
AP05/30/2007N16694000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022052lbl.pdf 6/4/2007
AP05/30/2007N20947000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022052_zyflo_toc.cfm 10/3/2008
AP09/4/2009SLR23251005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.pdf 8/28/2009
AP09/4/2009SLR23832005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020471s014,022052s005ltr.pdf 11/12/2009
AP011/30/2011SLR30835009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022052s009ltr.pdf 12/1/2011
AP011/30/2011SLR30869009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022052s009lbl.pdf 12/2/2011
AP010/27/2014SCM       




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