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FDA Drug Application 021335 by NOVARTIS

Application Number021335
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/10/2001N1597000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21335ltr.pdf 5/10/2001
AP05/10/2001N1598000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21335lbl.pdf 5/10/2001
AP05/10/2001N2131000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21335_Gleevec.cfm 5/10/2001
AP05/10/2001N7121000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110502.htm 12/9/2003
AP02/1/2002SE16107001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335s001_Gleevec.cfm 7/8/2003
AP02/1/2002SE12127001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21335s001ltr.pdf 2/1/2002
AP02/1/2002SE12129001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335s1lbl.pdf 2/1/2002
AP01/22/2002SCM5076002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335se8-Gleevec_lbl.pdf 4/9/2003
AP05/20/2003SE55646003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf 5/20/2003
AP05/20/2003SE56134003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se5-001ltr.pdf 7/23/2003
AP05/20/2003SE59957003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm 8/9/2004
AP012/20/2002SE19043004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335S004_Gleevec_Approv.pdf 6/4/2004
AP012/20/2002SE16106004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335s004_Gleevec.cfm 7/8/2003
AP012/20/2002SE12126004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335se8-Gleevec_lbl.pdf 12/20/2002
AP010/31/2003SLR6938006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21335slr006ltr.pdf 11/25/2003
AP010/31/2003SLR10312006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335S006_Gleevec_Approv.pdf 9/29/2004




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