Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021335
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLEEVEC IMATINIB MESYLATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
GLEEVEC IMATINIB MESYLATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/10/2001 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21335lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21335ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21335_Gleevec.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/31/2003 SUPPL-6 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21335slr006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335S006_Gleevec_Approv.pdf
12/20/2002 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335se8-Gleevec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335S004_Gleevec_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335s004_Gleevec.cfm
05/20/2003 SUPPL-3 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21588se5-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-335s003_21-588s001_Gleevec.cfm
01/22/2002 SUPPL-2 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335se8-Gleevec_lbl.pdf
02/01/2002 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21335s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-335s001_Gleevec.cfm
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/20/2003 SUPPL-3 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021588s001lbl.pdf
12/20/2002 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335se8-Gleevec_lbl.pdf
02/01/2002 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335s1lbl.pdf
01/22/2002 SUPPL-2 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21335se8-Gleevec_lbl.pdf
05/10/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21335lbl.pdf

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