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FDA Drug Application 019297 by EMD SERONO

Application Number019297
Application Type New Drug Application
Sponsor ApplicantEMD SERONO
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1987N19597000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019297_S000_ORIGINAL_APPROVAL_PKG.pdf 4/4/2008
AP012/23/1987N20302000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm126445.htm 7/29/2008
AP03/17/1988SCM       
AP011/26/1990SCS       
AP02/22/1990SCP       
AP02/19/1992SCM       
AP07/30/1990SCS       
AP04/15/1994SCS       
AP09/23/1994SLR       
AP04/10/1995SCS       
AP010/18/1996SLR       
AP011/13/1996SE13755014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019297_s014ap.pdf 11/20/1997
AP05/8/1997SCS       
AP05/23/1997SLR       
AP08/13/1998SCM       
AP09/19/1997SLR       
AP05/8/1998SLR       
AP010/19/2000SCS       
AP02/4/2000SLR3011021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19297-S021_Novantrone.pdf 2/4/2000
AP01/31/2001SLR       
AP02/9/2001SCS       
AP02/20/2002SLR3010024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19297s24ltr.pdf 2/20/2002
AP01/13/2003SLR4865025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf 1/13/2003
AP01/13/2003SLR4866026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf 1/13/2003
AP01/13/2003SLR4867027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf 1/13/2003
AP04/27/2005SLR11532028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019297s028ltr.pdf 4/28/2005
AP04/27/2005SLR11536028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019297s028lbl.pdf 4/28/2005
AP04/11/2007SCM16251029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019297s029LTR.pdf 4/20/2007
AP02/11/2009SLR21810030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf 2/12/2009
AP02/11/2009SLR21837030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019297s030,s031ltr.pdf 2/13/2009
AP02/11/2009SLR21838031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019297s030,s031ltr.pdf 2/13/2009
AP02/11/2009SLR21811031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf 2/12/2009
AP06/13/2010SLR25746033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019297s033,s034ltr.pdf 6/16/2010
AP06/13/2010SLR25781033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf 6/24/2010
AP06/13/2010SLR25782034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf 6/24/2010
AP06/13/2010SLR25747034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019297s033,s034ltr.pdf 6/16/2010
AP03/23/2012SLR32189035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019297s035ltr.pdf 3/26/2012
AP03/23/2012SLR32222035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035lbl.pdf 3/27/2012
AP03/23/2012SLR32223035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035mg.pdf 3/27/2012




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