Details for New Drug Application (NDA): 078340

NDA 078340 describes IMATINIB MESYLATE, which is a drug marketed by Amneal Pharms, Apotex, Breckenridge, Chartwell Rx, Dr Reddys, Eugia Pharma, Hikma, Mylan, Natco Pharma Ltd, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in fourteen NDAs. It is available from twenty-two suppliers. Additional details are available on the IMATINIB MESYLATE profile page.

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

Summary for 078340

Tradename:	IMATINIB MESYLATE
Applicant:	Sun Pharm
Ingredient:	imatinib mesylate
Patents:	0

Pharmacology for NDA: 078340

Mechanism of Action

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

Medical Subject Heading (MeSH) Categories for 078340

Antineoplastic Agents

Protein Kinase Inhibitors

Suppliers and Packaging for NDA: 078340

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	078340	ANDA	Sun Pharmaceutical Industries, Inc.	47335-472	47335-472-13	500 TABLET, FILM COATED in 1 BOTTLE (47335-472-13)
IMATINIB MESYLATE	imatinib mesylate	TABLET;ORAL	078340	ANDA	Sun Pharmaceutical Industries, Inc.	47335-472	47335-472-81	90 TABLET, FILM COATED in 1 BOTTLE (47335-472-81)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Dec 3, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Dec 3, 2015	TE:	AB	RLD:	No

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