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FDA Drug Application 021273 by ORGANON USA INC

Application Number021273
Application Type New Drug Application
Sponsor ApplicantORGANON USA INC
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
AP08/26/2005N12672000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021273ltr.pdf 8/31/2005
AP08/26/2005N12685000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021273lbl.pdf 8/31/2005
AP08/26/2005N17820000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021273s000TOC.cfm 9/11/2007
AP012/24/2008SCP21435003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021273s003ltr.pdf 12/31/2008
AP06/28/2010SE125833006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021273s006lbl.pdf 6/28/2010
AP06/28/2010SE125883006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021273s006ltr.pdf 7/1/2010
AP011/19/2013SCM       
AP09/10/2015SCM       




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