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FDA Drug Application 022159 by SEPTODONT HOLDING

Application Number022159
Application Type New Drug Application
Sponsor ApplicantSEPTODONT HOLDING
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
AP05/9/2008N19819000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022159s000ltr.pdf 5/14/2008
AP05/9/2008N20252000   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/022159s000_SUMR.pdf 7/17/2008
AP05/9/2008N23235000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022159_oraverse_toc.cfm 8/26/2009
AP01/9/2014SCM       
AP09/9/2013SCM       
AP04/9/2014SCM       
AP01/5/2015SCM       
AP01/26/2015SCM       
AP01/26/2015SCM       
AP03/18/2016SE845480011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022159s011lbl.pdf 3/22/2016
AP03/18/2016SE845482011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022159Orig1s011ltr.pdf 3/23/2016
AP01/7/2016SCM       
AP010/4/2016SCM       




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