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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021335
Company: NOVARTIS

Other Important Information from FDA

Products on NDA 021335

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GLEEVEC	IMATINIB MESYLATE	EQ 50MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No
GLEEVEC	IMATINIB MESYLATE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021335

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

Labels for NDA 021335

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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