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FDA Drug Application 020388 by PIERRE FABRE

Application Number020388
Application Type New Drug Application
Sponsor ApplicantPIERRE FABRE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1994N       
AP02/22/1996SLR       
AP05/24/1996SLR       
AP08/29/1997SLR16215003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1997/020388_S003_NAVELBINE INJECTION_AP.pdf 4/11/2007
AP04/16/1998SCM       
AP01/6/1998SLR       
AP09/16/1998SCP       
AP010/16/1998SLR       
AP06/8/2000SLR2925008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_Approv.pdf 6/8/2000
AP06/8/2000SLR2926008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388S008_Navelbine_prntlbl.pdf 6/8/2000
AP06/8/2000SLR2927008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-388s008_Navelbine.cfm 6/8/2000
AP05/12/2000SLR       
AP010/2/2001SE85409010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20388s10lbl.pdf 4/22/2003
AP010/2/2001SE86141010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20388s10ltr.pdf 7/24/2003
AP08/25/2000SLR       
AP011/29/2000SLR       
AP04/3/2002SCM       
AP011/5/2002SE82923014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20388se8-014ltr.pdf 11/5/2002
AP011/5/2002SE82924014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20388S014lbl.pdf 11/5/2002
AP011/5/2002SE817032014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020388_S014_NAVELBINE_INJECTION_AP.pdf 7/6/2007
AP03/14/2014SLR38809027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020388Orig1s027ltr.pdf 3/19/2014
AP03/14/2014SLR38844027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020388s027lbl.pdf 3/19/2014
AP05/23/2014SCM       
AP08/13/2014SCM       
AP08/21/2015SCM       
AP09/4/2016SCM       




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