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FDA Drug Application 021684 by EMD SERONO

Application Number021684
Application Type New Drug Application
Sponsor ApplicantEMD SERONO
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
AP05/25/2004N8822000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21684ltr.pdf 6/1/2004
AP05/25/2004N8844000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21684_gonal-f_lbl.pdf 6/1/2004
AP05/25/2004N13768000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021684s000_GonalTOC.cfm 3/21/2006
AP012/18/2007SLR18679007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021684s007lbl.pdf 12/27/2007
AP012/18/2007SLR18822007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021684s007ltr.pdf 1/9/2008
AP012/6/2007SCM18855008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021684s008ltr.pdf 1/9/2008
AP01/11/2013SCM       
AP02/6/2013SCM       
AP01/23/2013SCM       
AP01/31/2013SCM       
AP02/8/2013SCM       
AP02/14/2013SCM       
AP02/19/2013SCM       
AP04/4/2013SCM       
AP010/16/2013SCM37464036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021684s036lbl.pdf 10/18/2013
AP09/13/2016SCM       




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