Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021335
Company: NOVARTIS
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GLEEVEC | IMATINIB MESYLATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |
GLEEVEC | IMATINIB MESYLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |