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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207586

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NDA 207586 describes IMATINIB MESYLATE, which is a drug marketed by Amneal Pharms, Apotex, Chartwell Rx, Cspc Ouyi, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Hikma, Mylan, Natco Pharma Ltd, Novitium Pharma, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in sixteen NDAs. It is available from twenty 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-two suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

Summary for 207586

Tradename:	IMATINIB MESYLATE
Applicant:	Hikma
Ingredient:	imatinib mesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 207586

Antineoplastic Agents
Protein Kinase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Jul 13, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Jul 13, 2018	TE:		RLD:	No

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