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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Federal Trade Commission
Fish and Richardson
Harvard Business School
US Department of Justice

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078340

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NDA 078340 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. Twelve suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 078340
Applicant:Sun Pharma Global
Ingredient:imatinib mesylate
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 078340
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 078340
Suppliers and Packaging for NDA: 078340
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 078340 ANDA NorthStar RxLLC 16714-704 N 16714-704-01
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 078340 ANDA NorthStar RxLLC 16714-705 N 16714-705-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Dec 3, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Dec 3, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Johnson and Johnson
Chinese Patent Office

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