Application Information

This drug has been submitted to the FDA under the reference 021335/001.

Names and composition

"GLEEVEC" is the commercial name of a drug composed of IMATINIB MESYLATE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
021335/001 GLEEVEC IMATINIB MESYLATE CAPSULE/ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021335/002 GLEEVEC IMATINIB MESYLATE CAPSULE/ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021588/001 GLEEVEC IMATINIB MESYLATE TABLET/ORAL EQ 100MG BASE
021588/002 GLEEVEC IMATINIB MESYLATE TABLET/ORAL EQ 400MG BASE

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
021335/001 GLEEVEC IMATINIB MESYLATE CAPSULE/ORAL EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021335/002 GLEEVEC IMATINIB MESYLATE CAPSULE/ORAL EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
021588/001 GLEEVEC IMATINIB MESYLATE TABLET/ORAL EQ 100MG BASE
021588/002 GLEEVEC IMATINIB MESYLATE TABLET/ORAL EQ 400MG BASE
078340/001 IMATINIB MESYLATE IMATINIB MESYLATE TABLET/ORAL EQ 100MG BASE
078340/002 IMATINIB MESYLATE IMATINIB MESYLATE TABLET/ORAL EQ 400MG BASE
079179/001 IMATINIB MESYLATE IMATINIB MESYLATE TABLET/ORAL EQ 100MG BASE
079179/002 IMATINIB MESYLATE IMATINIB MESYLATE TABLET/ORAL EQ 400MG BASE
204285/001 IMATINIB MESYLATE IMATINIB MESYLATE TABLET/ORAL EQ 100MG BASE
204285/002 IMATINIB MESYLATE IMATINIB MESYLATE TABLET/ORAL EQ 400MG BASE
204644/001 IMATINIB MESYLATE IMATINIB MESYLATE TABLET/ORAL EQ 100MG BASE
204644/002 IMATINIB MESYLATE IMATINIB MESYLATE TABLET/ORAL EQ 400MG BASE

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