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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 207818

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NDA 207818 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 207818

Tradename:	IMATINIB MESYLATE
Applicant:	Natco Pharma Ltd
Ingredient:	imatinib mesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 207818

Antineoplastic Agents
Protein Kinase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Mar 1, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Mar 1, 2019	TE:	AB	RLD:	No

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