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FDA Drug Application 020671 by NOVARTIS PHARMS CORP

Application Number020671
Application Type New Drug Application
Sponsor ApplicantNOVARTIS PHARMS CORP
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
AP05/28/1996N       
AP02/4/1998SCS       
AP011/30/1998SE1693004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20671s4ltr.pdf 11/30/1998
AP011/30/1998SE1694004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20671s004.cfm 11/30/1998
AP011/30/1998SE1695004   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20671s4lbl.pdf 11/30/1998
AP01/18/2000SCM       
AP02/10/2000SCS       
AP08/3/2001SCS       
AP03/6/2002SLR2269009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20671s9ltr.pdf 3/6/2002
AP02/26/2003SE84503010PEDIATRIC STUDIES  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671SE8010PEDS.pdf 3/26/2003
AP03/11/2003SLR4667011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671slr011ltr.pdf 3/28/2003
AP05/9/2003SLR5665012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20671slr012_hycamtin_lbl.pdf 5/29/2003
AP05/9/2003SLR5822012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20671slr012ltr.pdf 6/8/2003
AP06/14/2006SE114313014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020671s014lbl.pdf 6/15/2006
AP06/14/2006SE114341014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020671s014LTR.pdf 6/20/2006
AP03/26/2010SLR25207016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020671s016,s017ltr.pdf 4/5/2010
AP03/26/2010SLR25223016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf 4/5/2010
AP03/26/2010SLR25224017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020671s016s017lbl.pdf 4/5/2010
AP03/26/2010SLR25206017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020671s016,s017ltr.pdf 4/5/2010
AP02/28/2014SLR38642020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020671s020lbl.pdf 3/4/2014
AP02/28/2014SLR38659020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020671Orig1s020ltr.pdf 3/5/2014
AP06/2/2015SLR42980021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020671Orig1s021ltr.pdf 6/4/2015
AP06/2/2015SLR42987021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020671s021lbl.pdf 6/4/2015




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