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FDA Drug Application 018925 by EXELA PHARMA SCS LLC

Application Number018925
Application Type New Drug Application
Sponsor ApplicantEXELA PHARMA SCS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/30/1984N       
AP07/10/1984SCM       
AP02/21/1985SCS       
AP09/15/1986SLR       
AP09/16/1986SCS       
AP09/15/1986SLR       
AP010/25/1988SLR       
AP04/13/2010SLR25272007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018925s007,019038s003ltr.pdf 4/19/2010
AP04/13/2010SLR25300007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018925s007,019038s003lbl.pdf 4/19/2010
AP011/2/2011SLR30493008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018925s008lbl.pdf 11/4/2011
AP011/2/2011SLR30523008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018925s008ltr.pdf 11/7/2011
AP04/11/2016SCM       




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