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FDA Drug Application 020471 by CHIESI USA INC

Application Number020471
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
AP012/9/1996N       
AP05/21/1997SCS       
AP05/30/1997SCM       
AP05/6/1997SCS       
AP09/8/1997SCS       
AP09/24/1998SCP       
AP09/4/1998SLR23358007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020471_s007_Zyflo Filmtabs.pdf 9/16/2009
AP04/23/2001SLR       
AP012/16/2002SLR23359009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020471_s009_Zyflo_Filmtab.pdf 9/16/2009
AP012/16/2002SLR9679009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20471slr009ltr.pdf 7/1/2004
AP09/28/2005SCM12832011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020471s011lbl.pdf 9/30/2005
AP09/28/2005SCM13498011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020471s011ltr.pdf 1/27/2006
AP08/21/2009SLR23250014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.pdf 8/28/2009
AP08/21/2009SLR23830014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020471s014,022052s005ltr.pdf 11/12/2009
AP06/8/2012SLR32896017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020471s017ltr.pdf 6/12/2012
AP06/8/2012SLR32943017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020471s017lbl.pdf 6/18/2012




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