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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Moodys
Queensland Health
Johnson and Johnson
Cerilliant
Julphar
AstraZeneca
US Army
Medtronic

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079179

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NDA 079179 describes IMATINIB MESYLATE, which is a drug marketed by Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, and Teva Pharms Usa, and is included in four NDAs. It is available from ten 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
Therapeutic Class:Antineoplastics
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 AvKARE, Inc. 42291-351 N 42291-351-90
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 079179 ANDA AvKARE, Inc. 42291-352 N 42291-352-30

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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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Healthtrust
Teva
Johnson and Johnson
Accenture
McKesson
AstraZeneca
UBS
Cantor Fitzgerald

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