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FDA Drug Application 021057 by ORGANON USA INC

Application Number021057
Application Type New Drug Application
Sponsor ApplicantORGANON USA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/29/1999N1065000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21057ltr.pdf 7/29/1999
AP07/29/1999N1066000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21057lbl.pdf 7/29/1999
AP07/29/1999N8748000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21057_Antagon.cfm 5/27/2004
AP06/7/2001SCS       
AP05/15/2001SLR       
AP012/20/2002SCS       
AP06/30/2008SLR20109007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021057s007lbl.pdf 6/30/2008
AP06/30/2008SLR20152007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021057s007ltr.pdf 7/2/2008
AP03/10/2016SCM       
AP012/19/2014SLR41369010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021057Orig1s010ltr.pdf 12/23/2014
AP012/19/2014SLR41588010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021057s010lbl.pdf 1/9/2015
AP01/12/2015SCM       
AP05/3/2016SCM       
AP08/2/2016SCM       




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