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FDA Drug Application 021765 by EMD SERONO

Application Number021765
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
AP03/25/2004N8114000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21765ltr.pdf 3/28/2004
AP03/25/2004N8221000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21765_follitropin_lbl.pdf 4/5/2004
AP03/25/2004N16283000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021765s000TOC.cfm 4/20/2007
AP012/20/2005SCS13348004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021765s004lbl.pdf 1/6/2006
AP012/20/2005SCS13411004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021765s004ltr.pdf 1/19/2006
AP07/5/2007SLR16962007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021765s007lbl.pdf 7/6/2007
AP07/5/2007SLR17255007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021765s007_ltr.pdf 7/10/2007
AP011/17/2015SCM       
AP01/17/2013SCM       
AP01/17/2013SCM       
AP02/6/2013SCM       
AP01/23/2013SCM       
AP01/31/2013SCM       
AP02/8/2013SCM       
AP02/14/2013SCM       
AP02/19/2013SCM       
AP04/4/2013SCM       
AP012/11/2013SCM       
AP012/19/2013SCM       
AP08/11/2014SCM       
AP04/29/2015SCM       
AP02/10/2016SCM       




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