Back to FDA Applications sponsored by EMD SERONO

FDA Drug Application 019764 by EMD SERONO

Application Number019764
Application Type New Drug Application
Sponsor ApplicantEMD SERONO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/8/1996N       
AP012/9/1996SLR       
AP01/21/1998SCM       
AP08/29/2000SCS       
AP07/9/1998SCM       
AP02/11/1999SCM       
AP04/4/2000SLR       
AP03/28/2000SCM       
AP06/7/2000SCM       
AP07/26/2000SLR       
AP04/11/2000SCM       
AP07/19/2000SCS21608011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019764_s011_SAIZEN INJECTION.pdf 1/12/2009
AP08/17/2000SCS       
AP05/3/2001SCM       
AP07/19/2001SCM       
AP09/6/2002SCS       
AP012/3/2001SCS       
AP012/20/2002SCM       
AP012/31/2002SCM       
AP010/17/2002SCS       
AP211/1/2004SE110580020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764s020ltr.pdf 11/15/2004
AP211/1/2004SE110581020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764s020lbl.pdf 11/15/2004
AP07/1/2003SLR6089023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19764slr023_saizen_lbl.pdf 7/8/2003
AP07/1/2003SLR6095023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19764slr023ltr.pdf 7/8/2003
AP07/9/2004SCP9735025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764scp,20604scp030ltr.pdf 7/14/2004
AP07/9/2004SCP9738025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf 7/14/2004
AP01/16/2007SCS15686030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s030lbl.pdf 1/18/2007
AP01/16/2007SCS15708030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s030ltr.pdf 1/25/2007
AP03/5/2007SLR15982034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s034lbl.pdf 3/7/2007
AP03/5/2007SLR16033034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s034ltr.pdf 3/15/2007
AP010/31/2007SCP18309035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s035lbl.pdf 11/7/2007
AP010/31/2007SCP18372035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s035ltr.pdf 11/8/2007
AP08/22/2007SLR17703037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s037lbl.pdf 8/23/2007
AP08/22/2007SLR17723037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s037ltr.pdf 8/27/2007
AP08/27/2007SLR17725039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019764s039lbl.pdf 8/30/2007
AP08/27/2007SLR17729039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019764s039ltr.pdf 8/30/2007
AP04/3/2012SLR32358049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf 4/5/2012
AP04/3/2012SLR32366049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019764s049lbl.pdf 4/6/2012
AP01/11/2013SCM       
AP01/11/2013SCM       
AP01/18/2013SCM       
AP01/19/2013SCM       
AP01/19/2013SCM       
AP01/19/2013SCM       
AP011/13/2013SCM       
AP02/7/2013SCM       
AP02/8/2013SCM       
AP06/11/2015SCM       
AP02/13/2013SCM       
AP01/31/2013SCM       
AP02/15/2013SCM       
AP02/15/2013SCM       
AP02/20/2013SCM       
AP04/5/2013SCM       
AP012/12/2013SCM       
AP011/18/2013SCM       
AP06/16/2014SLR39553072   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019764s072lbl.pdf 6/17/2014
AP06/16/2014SLR39579072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019764Orig1s072ltr.pdf 6/18/2014
AP09/30/2014SCM       
AP08/11/2014SCM       
AP02/16/2015SCM       
AP03/3/2015SCM       
AP06/12/2015SCM       
AP04/21/2016SCM       
AP09/7/2016SCM       




Back to FDA Applications sponsored by EMD SERONO