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FDA Drug Application 021314 by EXALENZ BIOSCIENCE

Application Number021314
Application Type New Drug Application
Sponsor ApplicantEXALENZ BIOSCIENCE
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
AP012/17/2002N5080000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21314_BreathID_lbl.pdf 4/9/2003
AP012/17/2002N9095000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21314ltr.pdf 6/7/2004
AP012/17/2002N13185000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021314s000_IDKitTOC.cfm 11/30/2005
AP02/26/2010SLR       
AP01/18/2013SCM       
AP010/28/2014SLR40892004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021314Orig1s004ltr.pdf 10/29/2014
AP010/28/2014SLR41019004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021314s004.pdf 11/18/2014
AP07/8/2016SCM46496005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021314Orig1s005ltr.pdf 7/12/2016
AP07/25/2016SCM       




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