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Generated: October 16, 2018

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Details for New Drug Application (NDA): 079179

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NDA 079179 describes IMATINIB MESYLATE, which is a drug marketed by Apotex Inc, Dr Reddys Labs Ltd, Mylan Pharms Inc, Sun Pharma Global, Teva Pharms Usa, and West-ward Pharms Int, and is included in six NDAs. It is available from eleven suppliers. Additional details are available on the IMATINIB MESYLATE profile page.

The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-three drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 079179
Tradename:IMATINIB MESYLATE
Applicant:Apotex Inc
Ingredient:imatinib mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079179
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 079179
Suppliers and Packaging for NDA: 079179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 079179 ANDA AvPAK 50268-426 50268-426-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-426-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-426-11)
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 079179 ANDA AvPAK 50268-427 50268-427-12 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-427-12) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-427-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 5, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Aug 5, 2016TE:ABRLD:No

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