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FDA Drug Application 022041 by SERB SA

Application Number022041
Application Type New Drug Application
Sponsor ApplicantSERB SA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/15/2006N15487000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022041lbl.pdf 12/19/2006
AP012/15/2006N16101000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022041s000_LTR.pdf 3/26/2007
AP012/15/2006N21349000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022041_cyanokit_toc.cfm 12/12/2008
AP02/4/2016SCM       
AP010/13/2010SLR26685004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022041s004ltr.pdf 10/19/2010
AP010/13/2010SLR26702004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s004lbl.pdf 10/19/2010
AP06/4/2009SLR22736005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022041s005lbl.pdf 6/10/2009
AP06/4/2009SLR22753005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022041s005ltr.pdf 6/16/2009
AP02/19/2010SLR24863007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022041s007ltr.pdf 2/26/2010
AP02/19/2010SLR24940007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022041s007lbl.pdf 3/3/2010
AP04/8/2011SLR28504008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf 4/11/2011
AP04/8/2011SLR28505009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022041s008s009lbl.pdf 4/11/2011
AP011/21/2013SCM       
AP07/3/2014SCM       
AP02/4/2016SCM       




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