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FDA Drug Application 020582 by ORGANON USA INC

Application Number020582
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
AP09/29/1997N6437000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020582_follistim_toc.cfm 8/7/2003
AP09/29/1997N14656000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20582_FOLLISTIM%2075IU%20AND%20150IU%20VIALS_APPROV.PDF 9/29/1997
AP011/18/1998SCF6438001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020582s001_follistim_toc.cfm 8/7/2003
AP011/18/1998SCF9036001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20582-S001_FOLLISTIM_APPROV.PDF 6/4/2004
AP03/26/1999SCM6439002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020582s002_follistim_toc.cfm 8/7/2003
AP03/26/1999SCM9035002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20582-S002_FOLLISTIM_APPROV.PDF 6/4/2004
AP04/18/2000SCS       
AP03/15/2001SCS       
AP05/25/2000SCS       
TA02/26/2002SE14618006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20582s6ltr.pdf 2/7/2002
TA02/26/2002SE14619006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20582s006lbl.pdf 2/7/2002
AP07/5/2002SCS       
AP07/10/2002SCS       




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