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FDA Drug Application 020984 by ORGANON USA INC

Application Number020984
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
AP08/18/1999N802000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20984ltr.pdf 8/18/1999
AP08/18/1999N803000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20984lbl.pdf 8/18/1999
AP08/18/1999N4165000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20984_Raplon.cfm 7/2/2001
AP01/19/2000SCS       
AP07/7/2000SCS       
AP011/22/2010SLR27081003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020984s003lbl.pdf 11/22/2010
AP011/22/2010SLR27090003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020984s003ltr.pdf 11/30/2010




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