Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021335
Company: NOVARTIS

• Other Important Information from FDA

Products on NDA 21335

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GLEEVEC	IMATINIB MESYLATE	EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
GLEEVEC	IMATINIB MESYLATE	EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

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