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FDA Drug Application 020604 by EMD SERONO

Application Number020604
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 Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/23/1996N       
AP01/16/1998SLR       
AP07/25/1997SCS       
AP01/21/1998SCM       
AP07/9/1998SCM       
AP07/9/1998SCS       
AP04/4/2000SLR       
AP03/28/2000SCM       
AP09/18/2000SCE       
AP07/17/2000SLR       
AP010/27/2000SLR       
AP04/11/2000SCM       
AP07/19/2000SCS23364012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020604_s012_SAIZEN INJECTION.pdf 9/16/2009
AP08/17/2000SCS       
AP06/13/2001SLR       
AP05/3/2001SCM       
AP09/6/2001SLR       
AP07/19/2001SCM       
AP09/6/2002SCS       
AP011/19/2001SCS       
AP012/3/2001SCS       
AP012/20/2002SCM       
AP012/31/2002SCM       
AP010/17/2002SCS       
AP012/1/2003SLR7053026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21597,20604slr026ltr.pdf 12/4/2003
AP012/1/2003SLR7066026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604s026_zorbtive_lbl.pdf 12/8/2003
AP012/1/2003SLR17525026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020604_S026_ZORBITIVE.pdf 8/6/2007
AP08/29/2003SE76605027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20604se7-027_serostim_lbl.pdf 9/9/2003
AP08/29/2003SE76606027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20604se7-027ltr.pdf 9/9/2003
AP08/29/2003SE723365027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020604_s027_SEROSTIM.pdf 9/16/2009
AP02/11/2005SCF11125029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20604s029ltr.pdf 2/17/2005
AP02/11/2005SCF11132029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20604s029lbl.pdf 2/17/2005
AP07/9/2004SCP9736030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19764scp,20604scp030ltr.pdf 7/14/2004
AP07/9/2004SCP9739030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19764scp,20604scp030_serostim_lbl.pdf 7/14/2004
AP08/24/2005SLR12673031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020604s031ltr.pdf 8/31/2005
AP08/24/2005SLR12687031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020604s031lbl.pdf 8/31/2005
AP09/21/2006SCS14951034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020604s034ltr.pdf 9/25/2006
AP09/21/2006SCS14971034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s034lbl.pdf 9/25/2006
AP011/27/2006SCS15422035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020604s035lbl.pdf 12/4/2006
AP011/27/2006SCS15427035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020604s035ltr.pdf 12/4/2006
AP07/13/2007SLR17288040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s040lbl.pdf 7/16/2007
AP07/13/2007SLR17345040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s040ltr.pdf 7/24/2007
AP07/13/2007SLR27870040   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/020604_s040_serostim.pdf 2/15/2011
AP08/27/2007SLR17726044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044lbl.pdf 8/30/2007
AP08/27/2007SLR17727044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044ltr.pdf 8/30/2007
AP08/27/2007SLR17740044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044_2lbl.pdf 9/4/2007
AP08/27/2007SLR17744044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044_v2ltr.pdf 9/4/2007
AP18/30/2007SLR17726044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044lbl.pdf 8/30/2007
AP18/30/2007SLR17727044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044ltr.pdf 8/30/2007
AP18/30/2007SLR17740044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020604s044_2lbl.pdf 9/4/2007
AP18/30/2007SLR17744044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020604s044_v2ltr.pdf 9/4/2007
AP08/31/2009SLR23971048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020604s048ltr.pdf 11/19/2009
AP04/3/2012SLR32357049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020604s049,019764s049ltr.pdf 4/5/2012
AP04/3/2012SLR32365049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020604s049lbl.pdf 4/6/2012
AP011/20/2012SCM       
AP02/8/2013SCM       
AP01/31/2013SCM       
AP02/15/2013SCM       
AP02/28/2013SCM       
AP112/17/2013SCM       
AP04/5/2013SCM       
AP012/11/2013SCM       
AP012/12/2013SCM       
AP06/16/2014SLR39586078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020604Orig1s078ltr.pdf 6/19/2014
AP06/16/2014SLR39625078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020604s078lbl.pdf 6/23/2014
AP09/17/2014SCM       
AP09/30/2014SCM       
AP08/11/2014SCM       




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