Details for New Drug Application (NDA): 021335

NDA 021335 describes GLEEVEC, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the GLEEVEC profile page.

The generic ingredient in GLEEVEC is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

Summary for 021335

Tradename:	GLEEVEC
Applicant:	Novartis
Ingredient:	imatinib mesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 021335

Antineoplastic Agents

Protein Kinase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	May 10, 2001	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	May 10, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 021335

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-001	May 10, 2001
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-001	May 10, 2001
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-002	May 10, 2001
Novartis	GLEEVEC	imatinib mesylate	CAPSULE;ORAL	021335-001	May 10, 2001

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