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FDA Drug Application 020214 by ORGANON USA INC

Application Number020214
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/17/1994N       
AP011/22/1994SCS       
AP010/4/1995SCS       
AP012/7/1994SLR       
AP06/21/1996SCP       
AP07/25/1996SCS       
AP012/3/1997SCS       
AP06/30/1997SCS       
AP03/27/2000SLR       
AP03/17/1999SCM       
AP03/27/2000SLR       
AP06/5/2001SLR       
AP07/20/2001SCS       
AP02/6/2004SLR7795016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20214slr016ltr.pdf 3/3/2004
AP06/4/2003SLR5807017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20214slr017ltr.pdf 6/8/2003
AP08/18/2004SLR10053021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20214s021ltr.pdf 8/25/2004
AP08/28/2008SE520698030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020214s030lbl.pdf 8/29/2008
AP08/28/2008SE520718030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020214s030ltr.pdf 8/29/2008
AP011/22/2010SLR27082034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020214s034lbl.pdf 11/22/2010
AP011/22/2010SLR27084034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020214s034ltr.pdf 11/30/2010
AP04/29/2013SCM       
AP01/6/2015SLR41518036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020214Orig1s036ltr.pdf 1/8/2015
AP01/6/2015SLR41541036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020214s036lbl.pdf 1/8/2015




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