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FDA Drug Application 020378 by EMD SERONO

Application Number020378
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
AP09/29/1997N       
AP09/18/1998SCM       
AP011/10/1998SCS       
AP05/25/2000SCS       
AP06/23/1999SCM       
AP01/5/2000SCS       
AP05/24/2000SE11382006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20378S6LTR.PDF 5/24/2000
AP05/24/2000SE18348006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-378S-006_review.pdf 4/14/2004
AP011/22/1999SCS       
AP01/5/2000SCS       
AP02/28/2001SCS       
AP08/31/2000SCM       
AP011/8/2000SCM       
AP010/26/2000SCM       
AP03/26/2001SCM       
AP07/23/2001SCS       
AP03/25/2004SCF8119015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20378scf015ltr.pdf 3/28/2004
AP03/25/2004SCF8257015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20378scf015_gonal_lbl.pdf 4/5/2004
AP07/15/2002SCS       
AP010/7/2002SCS       
AP010/8/2002SCS       
AP010/16/2002SCM       
AP07/16/2003SLR6173026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20378slr026,029ltr.pdf 7/28/2003
AP07/16/2003S6174029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20378slr026,029ltr.pdf 7/28/2003
AP08/13/2013SCM       
AP011/19/2015SCM       
AP01/18/2013SCM       
AP02/6/2013SCM       
AP01/23/2013SCM       
AP01/31/2013SCM       
AP02/15/2013SCM       
AP02/8/2013SCM       
AP02/14/2013SCM       
AP02/19/2013SCM       
AP02/20/2013SCM       
AP02/29/2016SCM       
AP02/26/2013SCM       
AP04/4/2013SCM       
AP01/30/2014SCM       
AP09/20/2013SCM       
AP012/11/2013SCM       
AP012/19/2013SCM       
AP08/11/2014SCM       
AP02/9/2015SCM       
AP03/3/2015SCM       




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