Details for New Drug Application (NDA): 021588

NDA 021588 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 021588

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

Pharmacology for NDA: 021588

Mechanism of Action

Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 021588

Antineoplastic Agents

Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 021588

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLEEVEC	imatinib mesylate	TABLET;ORAL	021588	NDA	Novartis Pharmaceuticals Corporation	0078-0401	0078-0401-34	90 TABLET in 1 BOTTLE (0078-0401-34)
GLEEVEC	imatinib mesylate	TABLET;ORAL	021588	NDA	Novartis Pharmaceuticals Corporation	0078-0649	0078-0649-13	3 BLISTER PACK in 1 CARTON (0078-0649-13) / 10 TABLET in 1 BLISTER PACK (0078-0649-26)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Apr 18, 2003	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Apr 18, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021588

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-002	Apr 18, 2003
Novartis	GLEEVEC	imatinib mesylate	TABLET;ORAL	021588-001	Apr 18, 2003

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